Article

A pragmatic cluster randomised trial evaluating three implementation interventions

Centre for Health Related Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK. .
Implementation Science (Impact Factor: 4.12). 08/2012; 7(1):80. DOI: 10.1186/1748-5908-7-80
Source: PubMed

ABSTRACT

Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.
A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.
Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.
This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.
ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).

Full-text

Available from: Jo Rycroft-Malone
RES E AR C H Open Access
A pragmatic cluster randomised trial evaluating
three implementation interventions
Jo Rycroft-Malone
1*
, Kate Seers
2
, Nicola Crichton
3
, Jackie Chandler
4
, Claire A Hawkes
1
, Claire Allen
4
,
Ian Bullock
5
and Leo Strunin
6
Abstract
Background: Implementation research is concerned with bridging the gap between evidence and practice
through the study of methods to promote the uptake of research into routine practice. Good quality evidence has
been summarised into guideline recommendations to show that peri-operative fasting times could be considerably
shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three
strategies for the implementation of recommendations about peri-operative fasting.
Methods: A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006
to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost
analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline
package, SD plus a web-b ased resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA).
The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included
duration of food fast, patients experiences, and stakeholders experiences of implementation, including influences.
ANOVA was used to test differences over time and interventions.
Results: Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were
recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect
size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for
PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to
practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-
professional tensions and a lack of cl arity for decision-making authority and responsibility.
Conclusions: This was a large, complex study and one of the first national randomised controlled trials conducted
within acute care in implementat ion research. The evidence base for fasting practice was accepted by those
participating in this study and the messages from it simple; however, implementation and practical challenges
influenced the interventions impact. A set of conditions for implementation emerges from the findings of this
study, which are presented as theoretically transferable propositions that have international relevance.
Trial registration: ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).
* Correspondence: j.rycroft-malone@bangor.ac.uk
1
Centre for Health Related Research, School of Healthcare Sciences, Bangor
University, Ffriddoedd Road, Bangor, UK
Full list of author information is available at the end of the article
Implementation
Science
© 2012 Rycroft-Malone et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
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distribution, and reproduction in any medium, provided the original work is properly cited.
Rycroft-Malone et al. Implementation Science 2012, 7:80
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Background
Implementation research is concerned with bridging the
gap between evidence and practic e through the scien-
tific study of methods to promote the systematic uptake
of clinical research findings and other evidence-based
practice into routine practice, and hence improve the
quality...of healthcare [1]. Whilst the number of
evidence-informed guidelines, frameworks , and stan-
dards are growing rapidly, their use in practice is fre-
quently reported as being unpredictable, often slow, and
complex [2-7]. This paper reports a large national imple-
mentation research trial to evaluate three strategies for
the implementation of best practice recommendatio ns
for peri-operative fasting.
Several systematic reviews summarise the evidence
about interventions for changing behaviour, using guide-
lines and research in practice, and quality improvement
collaboratives [8-14]. Whilst a consistent message from
these reviews is that the quality of implementation stud-
ies is generally poor, a number of strategies show some
promise. Wallin [15] grouped guideline implementation
strategies into the categories shown in Table 1.
Findings from these systematic reviews show that
interactive education approaches, audit and feedback, re-
minder systems, and opinion leadership may have some
impact. Schouten et al. [13] also found that quality im-
provement collaborative approaches showed moderate
positive results in some controlled studies. Additionally,
it is suggested by Grimshaw et al. [10] that passive
dissemination of guidelines should not be discounted
because it offers a cheaper, feasible approach that may
show effe ctiveness. They found that multi-faceted inter-
ventions were not necessarily more effective than single
interventions [10]. Finally, the authors of all these
reviews point out that very rarely are the cost conse-
quences of implementation and quality improvement
considered within study designs. A further critique of
the evidence base is that there has been a lack of atten-
tion to implementation processes and theory within
trials, which means that it is often difficult to determine
why interventions may have worked (or not).
There is a growing and persuasive body of evidence
that serves to highlight that the implementation of evi-
dence into practice may be influenced by many factors,
including those that could be considered organisational
or contextual [16-20]. This highlights that implementa-
tion strategy de velopment and the evaluation of imple-
mentation efforts need to capture contextual dimensions
and pay attention to a broad range of influences.
Fasting practice
Millions of people are admitted for elective surgery each
year. In preparation for anaesthesia, fasting regimes are
imposed in order to minimise the risk of regurgitation
Table 1 Effectiveness of interventions for guideline development
Dissemination / educational strategies
Educational materials Mixed effects
Conferences, courses Mixed effects
Different education strategies Mixed effects
Educational outreach visits Effective
Mass media campaigns Mostly effective
Social interaction strategies
Interaction small-group meetings Mostly effective
Feedback on performance Mixed effects
Opinion leaders Mixed effects
Multi-professional collaboration Effective
Decision support strategies
Reminders Mostly effective
Computerised decision support Mostly effective
Organisational strategies
Introduction of computers into primary care to improve clinical performance Mostly effective
Expanding professional roles Mixed effects
Total quality management/quality improvement Limited effects
Financial interventions Effective
Patient-orientated strategies
Patient mediated interventions Mixed effects
Adapted from Wallin et al. 2009 and Grimshaw et al. 2004.
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and aspiration of stomach contents [21]. Traditional
fasting rules determine that patients are nil by mouth
from midnight for a morning theatre list or have a light
breakfast for an afternoon list. However, there is good
quality robust research synthesised into national guide-
lines that recommend it is safe for healthy adult patients
undergoing elective surgery to have water and clear
fluids up to two hours before the induction of anaesthe-
sia and food up to six hours prior to induction [21-24].
Despite a robust evidence base to guide practice, surveys
show that prolonged fasting is common across the globe
[25-27]. A UK survey of departments of anaesthesia
revealed that 93 (62%) followed a fasting from midnight
policy [28], whilst fluid intake until four, three, and two
hours prior to surgery was reported as acceptable under
current guidelines at 40, 31, and 71 departments respect-
ively. Prolonged fa sting can lead to dehydration, electro-
lyte imbalance, nausea, and a reduced nutritional intake
[29,30] and discomfort for patients [24].
No research was found reporting attempts to improve
fasting times. This gap provided an opportunity to evalu-
ate implementation interventions to promote the use of
recommendations from a national guideline:
Preoperative fasting in adults undergoing elective
surgery –‘the 2 and 6 rule [24]
2 - Intake of water up to two hours before
induction of anaesthesia.
6 - A minimum preoperative fasting time of six
hours for food (solids, milk, and milk-containing
drinks).
Postoperative resumption of oral fluids in healthy
adults when fully awake.
Summary
The evidence base for implementation provides some in-
formation about the strategies that might be more effect-
ive than others for implementing guidelines. However, it
is not clear which strategies might be more or less ef-
fective in different contexts, with different clinical topics
and professional groups. Therefore, our trial objective
was to evaluate three interventions to implement fa sting
recommendations into practice with a focus on summa-
tive outcomes (duration of fasting) and the processes of
implementation (intervention delivery, influences, and
other types of impacts).
There have been calls for more robust implementation
intervention studies [e.g., 15], and to our knowledge this
study is the first and largest implementation research
trial to attempt to improve peri-operative fasting times.
Methods
Design
This study was a pragmatic cluster randomised con-
trolled trial (RCT) using time series with embedded
mixed methods process and economic evaluation. The
trial had three arms: standard dissemination (SD) of a
188 eligible UK Acute NHS Trusts
N=21 hospital trusts
1. Standard Dissemination
package n=7
2. Standard dissemination +
web based tool championed by
opinion leader n=6
3. Standard dissemination + PDSA
n=6
Pre-intervention data
collection n=7
N=19 hospital trusts randomised
2 lost in access process
Pre-intervention data
collection n=6
Pre-intervention data
collection n=6
Post intervention data
collection n=7
Post intervention data
collection n=6
Post intervention data
collection n=6
Intervention n=7
Intervention n=6
Intervention n=5
1 site unable
to deliver
intervention
due to
sickness of
facilitator
Figure 1 Flow chart from recruitment to post-intervention data collection.
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guideline package; SD plus a web-based education pack-
age championed by an opinion leader, and 3) SD plus a
Plan-Do-Study-Act (PDSA) approach. Hospital Trusts
were randomised to one of the three implementation
interventions. Data were collected eight months pre-
and post-intervention. The intervention period was six
months. The CONSORT flow diagram is shown in
Figure 1.
Theoretical framework
The theoretical framework (Figure 2) developed for this
study is based on the Promoting Action on Research Im-
plementation in Health Services (PARIHS) framework
[20,31]. Successful implementation (SI) is represented as
a function (f) of the nature and type of evidence (E) (in-
cluding research, clinical experience, patient experience,
and local information), the qualities of the context (C) of
implementation (including culture, leadership and evalu-
ation), and the way the process is facilitated (F) (internal
and/or external person who enables implementation
processes); SI = f(E,C,F). The framework was used to
incorporate interventions and to guide decisions about
data collection, qualitative data analysis, and synthesis.
Setting
All acute care NHS Trusts acro ss the UK conducting
elective surgery were invited to participate, but needed
to be able to fulfil the following criteria:
1. there were a sufficient volume of suitable
participants, i.e., at least 40 adult patients per
timepoint undergoing a routine surgical operation as
inpatient or day patient;
2. they provided gynaecological, orthopaedic, or general
surgical services;
3. they would allow staff to partic ipate in the project;
4. they would provide local investigators.
Participants
Primary outcome data were collected from individual
patients undergoing elective and routine general, ortho-
paedic, or gynaecological surgery.
Figure 2 Theoretical framework.
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Inclusion criteria
1. Patients aged 18 and over.
2. Patients who could provide informed consent.
Exclusion criteria
1. Patients who were critically ill.
2. Emergency or trauma patients because we were
evaluating routine fasting regimes.
3. Patients who were unable to give informed consent
Duration of food fast was collected from all patients,
but other secondary outcome data were collected from a
sample of patients who participated in primar y outcome
data collection and a purposive sample of staff.
Interventions
Trusts were randomised to one of the following inter-
ventions; two of which could be described as complex
interventions. See Table 2 for a summary of intervention
characteristics and expected mechanisms of action. The
null hypothesis was that all interventions are equally
effective.
Standard dissemination
SD of a guideline package, which included:
1. A copy of the RCN/RCA guideline, which included
an overview of the guideline development process
and those involved, recommendations, algorithm
poster, and audit criteria.
2. A patient version of the guideline.
3. A PowerPoint presentation outlining some principles
of guideline implementation.
We attempted to mirror, as far as possible, the dissem-
ination process of the National Institute for Health and
Clinical Excellence (NICE). The package was distributed
once via the post-at the beginning of the intervention
period and was targeted at the senior levels of the NHS
Trust organisation. Packs were posted to named medical
directors, nursing directors, clinical governance leads,
and audit leads at each Trust. Packs were also sent to
the English Strategic Health Authorities and the Health
Boards in Northern Ireland, Wales and Scotland.
Standard dissemination of guideline package plus web-
based educational package championed by an opinion
leader(s)
A web-based resource was developed from the content
of the guideline package, accessible to trusts allocated to
this intervent ion. The web-based resource was inter-
active, incorporating educational tools such as self-check
tests, working through clinical scenarios, and a patient
digital story (http://www.rcn.org.uk/development/prac-
tice/perioperative_fasting).
The resource was championed by opinion leaders
working in participating surgical areas. Opinion leaders
were identified by key contacts at the NHS Trusts
through a nomination process based on criteria de vel-
oped from previous research [32-34]:
1. Does this person have credibility across different
professional groups? i.e., will different professional
groups all take on knowledge from this person and
respect their ability?
2. Do they have an authority and presence recognised
by their colleagues?
3. Do they have good communication skills?
4. Do they treat all colleagues with respect?
Table 2 Intervention details
Intervention
Standard
dissemination
Web-based resource PDSA
Source Guideline Guideline and RCN learning resource Adapted from Modernisation Agency Improvement
Leaders Guide
Format Paper and CD Computer Package and facilitator led
Target Trust Multi-professional staff, individuals
and/or groups
Multi-professional staff groups
Delivered by Unknown Local opinion leader PDSA facilitator
Duration Six months Six months Six months
Number of events One Multiple but not specified Six meetings specified plus local audit activity
Proximity to practice Remote Arms length Grassroots
Setting Trust Ward/theatre Ward/theatre
Intended mechanism of
action
Awareness raising Social influence Facilitation
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5. Do they have the ability to convince colleagues about
reducing fasting times through the intervention?
The selection of more than one opinion leader was
permitted. Training on the use of the web-based re-
source was provided to opinion leaders at the start of
the implementation phase.
3. Standard dissemination of guideline package plus plan-
do-study-act
The PDSA quality improvement approach includes mak-
ing small changes and test cycles to see whether an
improvement occurs in the system or process [35]. Crit-
ical to this intervention is the potential to collaborate,
which in this study was possible at a local level between
teams and individuals. This intervention also included a
diagnosis phase based on the Seven S Model [18,36,37].
A dedicated facilitator with relevant clinical and/or man-
agerial experience was identified by each trust s key con-
tact. Facilitators had a one-day training session. The
PDSA package used in this study is available on request.
All trusts received their individual baseline mean food
and fluid fasting times at the beginning of the interven-
tion phase.
Outcomes
Primary outcome
The primary outcome was the duration of fluid fast prior
to induction of anaesthesia. Data on fasting were col-
lected by the local investigators by asking patients pre-
operatively when they last ate, when they last drank, and
post-operatively when they had a first drink. This infor-
mation was checked against reported information in
their notes. These data were recorded on digitally read
data sheets developed for this study (Additional File 1:
Table S1) coded for the Trusts and for individual
patients. Local investigators received trainin g about how
to collect these data. Data were collected four times
pre-intervention and four times post-intervention, with
up to two months interval between data collection
points.
Secondary outcomes: Process evaluation
1. Patients experiences of fasting:
Questionnaire: A 17-item digitally read questionnaire
(Additional File 2: Table S2) was developed and given
to all pati ents who consented to duration of fasting
data collection. Patients could return completed
questionnaires via a sealed box on the ward or in a
postage-paid envelope.
Interviews: Semi-structured audio-recorded
interviews were conducted with patients from each
Trust to explore their experiences of fasting, pre- and
post-intervention. Ward staff identifie d potential
patients for interview and the majority of patients
were interviewed within three days post-operatively.
2. PDSA Facilitator and opinion leader experiences of
implementation including activities, barriers and
facilitators and perceived impact were collected
through audio recorded semi-structured telephone
interviews both pre- and post-intervention.
3. Key contact experiences of intervention
implementation and impact including resource use
were collected through audio-recorded semi-
structured telephone interviews conducted pre- and
three months post-intervention.
4. Staff experiences of fasting practice and any impacts
of the study were collected through multi-
professional audio recorded focus groups in a sample
of the trusts that had been identified within each of
the intervention arms as having made the largest
change to fasting times, and those that had made the
smallest/no/marginal change.
5. Organisational culture was evaluated through the
administration of the Learning Organiz ation Survey
[38]. The questionnaire was distributed by local
investigators to a conven ience sample of doctors,
nurses, health care assistants, operative department
assistants and porters once pre-intervention period
and once post-intervention.
6. Cost analysis of developing and implementing the
three interventions from a national perspective (cost
of rolling out a particular intervention across the
NHS), and from the perspective of a single trust
(cost of all activity and resource used by trust
employees in implementation).
Sample size
Power calculation
This was a complex, multi-level study design, including
three intervention groups, fasting time being measured
for each patient, with randomisation at Trust level.
Whilst fasting time was measured in each patient,
comparing fasting times before and after the interven-
tion was done at the Trust (randomised unit ) level.
Because patients will generally only be in hospital for
surgery at one timepoint we could not measure the
effect of the intervention on fasting time within individ-
ual patients. The number of patients in that Trust whose
fasting time was measured will affect the precision of
the fasting time estimated for an individual hospital.
The sample size calculation was based on information
from an audit of fasting time [28]. The study had 80%
power to detect an effect size of 2 (a difference of 4 hours
and SD 2 hours) with a two-sided 5% significance level,
which required six Trusts in each of the three interven-
tion groups. These calculations were carried out using
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the sample size calculator for one way ANOVA in
MINITAB13.
At the time of designing the study, there was very little
information published about average fasting time, be-
yond reports of fasting times of around 10 hours (e.g.,
Seymour [39] reported mean fasting times of 11.5 hours
and 10.4 hours for elderly care patients), thus there was
little on which to base for the sample size calculation.
Given the apparent high reported mean and consistent
claims of long fasting times , it appeared that we could
be sure the mean fluid fasting time would substantially
exceed the target of two hours prior to introduction of
the guidelines. A national survey indicated tradi tional
guidelines still prevailed [28]. If the additional effort of
implementation beyond simply providing the guidelines
is to be worthwhile, there needs to be a substantially
greater reduction in fasting time and there was certainly
scope for large impact. After the study had been
designed, a report of fasting times for women having
scheduled caesareans was published and reported a
mean fluid fast of 11 hours (SD 3 hours) and a mean
food fast of 13 hours (SD 2 hours) [40]. Breuer et al.
[41] also found mean fluid fast times of 10 hours and
mean food fast times of 15 hours. Given that current
practice appeared to be so far away from the guideline
recommendations, it seemed reasonable to expect the
more intensive intervent ions would have a substantial
impact on fasting time and would not otherwise be clin-
ically worthwhile, hence a large effect size was used in
the sample size calculation.
The project successfully recruited 19 Trusts. Trusts
represented the four UK countries of England (15
Trusts), Scotland (2 Trusts), Wales (1 Trust) and North-
ern Ireland (1 Trust) and are referred to as Trust A, B,
C et al. At each fasting time data collection point, a tar-
get of collecting fasting times from 40 patients was set.
Randomisation
Each participating Trust was given an ID number. The
randomisation schedule was computer-generated cen-
trally and prepared by a statistician who was independ-
ent of the project team. Allocation was thus concealed
and could not be foreseen in advance of, or during
enrolment. Trusts were allocated to one of three imple-
mentation interventions, which resulted in six in two
arms and se ven in the other. Trusts were informed of
their allocation by a project researcher as near as
possible to the intervention period.
Blinding
Blinding of local investigators, research fellows or trust
staff to inter ventions was not possible because the inter-
vention required their active participation. Patients were
aware of the study, but not informed of the intervention
allocated to the trust.
Ethics
This study was approved by a multi-site ethics commit-
tee (06/MRE01/20). It took approximately 12 months
before all of the trusts gave local research govern ance
approval.
Analysis
Numerical data
Digitally read duration of fasting data sheets and patient
experience questionnaires were scanned, saved as
comma separated variable files (csv files), and then
imported into SPSS version 14 where data were cleaned
before analysis. Analysis was conducted at the cluster
level; for each Trust, mean fasting times were calculated
at each assessment timepoint. At each timepoint, the
differences in mean fasting times between the three
intervention groups were compared using analysis of
variance (ANOVA). A repeated measure ANOVA across
the timepoint means for all trusts, within each interven-
tion group, was conducted. The trend coefficient was
not significantly different to zero: there was no e vidence
of trend over time pre-or post-intervention [42] there-
fore data were combined across timepoints (1 to 4 and 5
to 8) and simple pre- and post-interventio ns compari-
sons were conducted using t-tests. The significance level
used for all tests was 5%. The effect size was calculated
for each of the web-based and PDSA interventions
compared to SD for change in fluid fasting time between
pre- and post-intervention. Confidence intervals for the
effect size are based on a non-central t distribution [43].
Patient experience questionnaires were analysed in
SPSS using descriptive statistics, chi squared tests were
used to compare characteristics pre- and post-
intervention.
Learning organization survey data were entered into
Excel and a random sample of 10% of the data entry was
quality checked before being exported into SPSS version
14. Descriptive and inferential statistics were conducted.
Qualitative data
Audio-recorded individual and focus group interviews
were transcribed in full. Data were analysed within data
set and managed in N*DIST 5 (pre-intervention) and
NVIVO 7 (post-intervent ion). A combined inductive and
deductive thematic analysis process was used whereby a
sub-set of transcripts within a data set (e.g., patient
interviews pre-intervention) were analysed inductively
by JC and CH and then an analysis framework develo ped
with JRM, which was then applied to the remainder of
the data in that set.
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The theoretical framework guided the integration of
findings across data sets.
Results
Participants and data collected
All 188 acute trusts in the four countries were invited to
participate. Trust chief executi ves, medical and nursing
directors (Binleys database) were sent a letter of invita -
tion. A total of 19 Trusts were recruited and remained
in the trial. We have no reason to believe that the char-
acteristics of participating Trusts were different from
any other NH S Trusts. However, given their willingness
to participate, we have to assume they have an interest
and therefore motivation to want to do something about
their fasting times, which may have made them atypical
of other non-participating trusts. Data were collected be-
tween November 2006 and February 2009 at a time
where the NHS was undergoing major reform under a
previous administration (see Table 3 for data collected).
Anecdotal feedback from some sites that made further
enquiries, but who then did not participate, would sug-
gest that engaging in an additional initiative at a time of
change was not feasible for them. Seven trusts were allo-
cated to SD, six to SD plus web-based resource cham-
pioned by an opinion leader, and six to SD plus PDSA.
One PDSA trust did not implement the intervention due
to staff sickness.
Not all trus ts were able to collect data for all eight
timepoints. Pre-intervention (because of lengthy govern-
ance procedures), three trusts had information from
timepoint four only, four trusts had information from
timepoints three and four, 12 trusts had information
from more than two pre-intervention timepoints. Post-
intervention, one trust had information from only one
timepoint, one trust had information for two post-
intervention timepoints, 17 trusts had inf ormation from
more than two post-intervention timepoints.
Duration of fluid and food fast pre- and post-intervention
Trends over timepoints
ANOVA showed no significant difference in mean over
time for either food or fluid fast time at any Trust pre-
intervention and post-intervention. Additionally within
each intervention group there was no evidence of a
trend across time pre-or post-intervention (Table 4).
Pre-intervention fluid and food fasting times
Across all hospitals, information was gathered from
1,575 patients in total in the pre-intervention period
(fluid fast time was missing for 135 patients and food
fast time missing for 140 patients). There was no signifi-
cant difference in the mea n food fasting time across the
four timepoints (ANOVA, p = 0.677), the overall mean
food fasting time pre-intervention was 14.0 hours (95%
CI 13.6, 14.4). Also, there was no significant differ ence
in the mean fluid fasting time across the four timepoints
(ANOVA, p = 0.877), the overall mean fluid fasting time
pre-intervention was 9.63 hours (95% CI 8.67, 10.6). For
68.4% of patients the fluid fast exceeds six hours, and for
31.3% of patien ts it exceeds 12 hours in the pre-
intervention period. The intracluster correlation for food
fasting time pre-intervention was 0.027 and for fluid
fasting was 0.12.
Post-intervention fluid and food fasting times
Across all Trusts information was gathered from 1930
patients in total in the post-intervention period (fluid
fast was missing for 16 9 patients and food fast for 153
patients post-intervention). There was no significant dif-
ference in the mean food fasting time across the four
Table 3 Summary of data collected across timepoints and intervention groups
Pre-Intervention
(2007 to 2008)
Post-Intervention
(2008 to 2009)
Total
Food fast duration information 1,435 1,777 3,212
Fluid fast duration information 1,440 1,761 3,201
Patient experience questionnaires 1,069 1,215 2,284
Local investigator audit 54 54
Interviews with key contacts 16 12 28
Interviews with facilitators and opinion leaders 9 12 21
Interviews with participants who were both key contacts and facilitators or opinion leaders 3 3
Interview with patients about their experiences 35 35 70
Completed Learning Organisation Surveys (LOS) 758 318 1,076
Focus Group participants (in five groups) 32 32
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timepoints (ANOVA, p = 0.951) or in the mean fluid
fasting time across the four timepoints (ANOVA,
p = 0.311). The mean food fast was 14.3 hours (95% CI
13.8, 14.8) and mean fluid fast 8.72 hours (95% CI 7.87,
9.57).
Comparing the three intervention groups pre-and post-
intervention
In the pre-inte rvention period there was no significant
difference in the mean food fast time between interven-
tions (ANOVA, p = 0.662). All the intervention groups
appeared to be similar with regard to food fast. There
was also no significant difference in the mean fluid fa st
time in the pre-intervention period across the interven-
tion groups (ANOVA, p = 0.506).
Post-intervention there was no significant difference in
the mean food fast time between intervention groups
(ANOVA, p = 0.641). In the post-intervention phase all
the intervention groups appeared to be similar with re-
gard to food fast. There was also no significant differ-
ence in the mean fluid fast time in the post-intervention
period between the intervention groups (ANOVA,
p = 0.751).
The mean food and fluid fasting times for each inter-
vention group at both pre- and post-intervention are
shown in Table 5 together with the change in mean food
and fluid fasting time (from pre-intervention to post-
intervention) within each intervention group. The
changes within each intervention group are small. For
mean food fast, using a generalised linear model, neither
the intervention nor the variable indicating pre/post-
intervention is significant; Figure 3 compares the pre-
and post-intervention food fast data for each interven-
tion group. Similarly for mean fluid fast, using a general-
ised linear model, neither the intervention nor the
variable indicating pre/post-intervention is sign ificant;
Figure 4 compares the pre- and post-intervention fluid
fast data for each intervention group. Consid ering the
change in fluid fasting time, the effect size for the web-
based inte rvention compared to SD alone is 0.33 (95%
CI 0.78, 1.42) and for PDSA compared to SD alone is
0.12 (95% CI 0.97, 1.21). These are small effect sizes;
neither intervent ion shows the substantial impact
beyond SD that would be required to reduce the mean
fluid fasting time close to that recommended in the
guidelines. For all three intervent ion groups, the post-
intervention mean fluid fast time remains substantially
above the guideline recommendation of two hours. In-
deed, for 62.7% of patients the fluid fast exceeds six
hours (the recommendation for food fast) and for 27.9%
of patients it exceeds 12 hours.
Summary pre- and post-intervention fasting times
Both fluid and food duration of fasting data shows no
significant change post-intervention for any of the three
interventions. The effect sizes of the more intensive
interventions compared to SD alone are small. Duration
of fluid fast continues to substantially exceed the two-
hour recommendation and food fast remains substan-
tially longer than six hours regardless of the intervention
Table 4 Intervention group across pre-and post-intervention timepoints
Intervention Pre-intervention Post-intervention
Food ANOVA Fluid ANOVA Food ANOVA Fluid ANOVA
Standard dissemination p = 0.981 p = 0.951 p = 0.872 p = 0.160
SD + web-resource/opinion leader p = 0.410 p = 0.716 p = 0.536 p = 0.814
SD + PDSA p = 0.958 p = 0.981 p = 0.748 p = 0.714
Table 5 Mean food and fluid fasting times in hours with 95% confidence intervals for each intervention group pre-
and post-intervention and for change in mean fasting time from pre-to post-intervention
Intervention Pre-intervention Post-intervention Change
Food Fluid Food Fluid Food Fluid
Standard dissemination 14.2 10.1 14.4 8.97 0.16 1.16
(95% CI 13.2, 15.2) (95% CI 7.74, 12.5) (95% CI 13.4, 15.4) (95% CI 6.77, 11.2) (95% CI1.08, 0.76) (95% CI 0.64, 2.96)
SD + web resource/opinion leader 13.8 8.83 14.5 8.25 0.74 0.58
(95% CI 13.0, 14.6) (95% CI 7.27, 10.4) (95% CI 13.4, 15.7) (95% CI 6.92, 9.58) (95% CI 1.99, 0.52) (95% CI 1.06, 2.21)
SD + PDSA 14.0 9.86 14.0 8.90 0.05 0.96
(95% CI 13.5, 14.6) (95% CI 8.02, 11.7) (95% CI 12.9, 15.0) (95% CI 7.28, 10.5) (95% CI 1.13, 1.24) (95% CI 0.32, 2.23)
All intervention groups 14.0 9.60 14.2 8.91 0.27 0.91
(95% CI 13.7, 14.3) (95% CI 9.00, 10.2) (95% CI 13.9, 14.6) (95% CI 8.46, 9.36) (95% CI 0.80, 0.25) (95% CI 0.16, 1.66)
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used. Thus no particular intervention strategy was more
effective than another.
Cost analysis
A cost analysis of the three interventions was under-
taken (see Additional File 3). Given that standard inter-
vention was used in all three arms, the arm that received
just standard intervention will by definition, have the
lowest cost. One might assume this would be the most
cost-effective intervention if the three approaches were
shown to have equal effectiveness. Whils t the study did
not detect a significant difference, it was not designed to
demonstrate equivalence, and therefore it is not possible
to say that SD is the most cost-effe ctive approach. In
Figure 3 Mean and 95% CI for food fast time for each intervention group comparing pre- and post-intervention results.
Figure 4 Mean and 95% CI for fluid fast time for each intervention group comparing pre- and post-intervention results.
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fact, the variation in outc ome within each intervention
arm is likely to reflect the significant variation in activity,
and therefore the resource use and cost, between the in-
dividual Trusts within each inter vention arm.
Patient experience
Findings from the questionnaires (n = 2,284, of which
1,069 were pre-intervention and 1,215 were post-inter-
vention) and interviews (n = 70) relate to provision of in-
formation, management of delay and symptoms of
fasting.
Provision of information
Information about fasting was provided at least once for
89% of patients pre-intervention and for 91.6% of
patients post-intervention. Information was sent by the
hospital before admission for 55.8% of patients in the
pre-intervention period and for 55.9% of patients post-
intervention. One-fifth of patients (19.7% pre-intervention
and 23.4% post-intervention) had information provided
during the pre-admission clinic, but did not have informa-
tion sent to them. For about a tenth of patients (10.7%
pre-intervention and 10.6% post -intervention), they
reported information about stopping eating and drinking
only being provided on admission to the ward.
Patients liked clear consistent information, with repeti-
tions being useful. Generally, patients were advised to
fast as if they were going to be first on the list. Most
patients reported complyi ng with instructions and in
many cases were overly cautious by choosing to fast for
longer than they needed to, 18.9% of patients pre-
intervention and 18.1% post-interventio n reported
choosing to stop eating or drinking prior to their oper-
ation at different times to those recommended by the
staff.
Management of delay
Interview data showed that patients were tolerant of
busy ward environments and often sympathetic to the
need to prioritise the list order, sometimes rationalising
that delays are due to emergencies or that organising the
list is challenging. Patients reported being frustrated by
not being reviewed if their operation was delayed.
Symptoms of fasting
Approximately one-half of the patients completing the
survey (46.5% pre-intervention and 44% post-interven-
tion) felt hungry before their operation, however, the
majority of patients (70.7% pre-intervention and 65.4%
post-intervention) experienced thirst.
The impact and process of implementation
Process e valuation data show a detailed picture of imple-
mentation processes within and across the 19 trusts and
that the study impacted in other ways other than on the
primary outcome. These findings are described below
under the main elements of the conceptual framew ork:
evidence, context, and facilitation.
Impact
Table 6 summarises some of the impacts of the study
had in trust s described by facilitators, opinion leaders
and key contacts. The study may have had an impact on
aspects of practice and service delivery that did not
translate into changes to length of fast. Some of the
influences on attempts to changing practice are outlined
below (and will be described in detail in a separate
publication).
Evidence
The research underpinning the fasting recommendations
could be judged as strong, coming from robust RCTs,
and badged by relevant UK Royal Colleges and Soci-
eties. Interview data suggests that most nursing and
anaesthetists interviewed thoug ht the evidence under-
pinning the recommendations was good and the guide-
line credible, for example:
...I am quite happy about the evidence base ... this
guideline is not nego tiable... you cant say well I
dont like this bit of it...its based on best evidence.
(Trust G, Key Contact and Change Agent [nurse])
Issues were raised about the interpretation of some of
the recommendations, such as what clear fluids meant,
and the amount of water patients could drink.
Anaesthetists reaction to the evidence base tended to-
wards conservative behaviour, which seem ed to be based
on prior experience where lists had worked well using
traditional fasting rules, for example:
... Why the extra aggro if theres a sudden chan ge in
the list...Ive been doing it x years and Ive never had
a cancellation because of that.. I personally... modify
the rules. If somebody turns up having had a jug of
water and its only one hour and 45 minutes I ll go
ahead and anaesthetise them. Other guys will
say...lets cancel, postpone. ( Trust L, Anaesthetist
Key Contact and Change Agent)
Context
Contextual factors were important influences on indivi-
duals and trusts capability to change practises in line
with guideline recommendations, not least that it is
challenging to change service delivery in a constantly
changing environment. Three main findings are outlined
here.
Inter-professional issues
Inter-professional relationships were a significant emer-
gent theme across all data. This incorporated different
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professional approaches, leadership, power and hierarch-
ical structures, and professional cultures. Although we
did not set out to specifically explore professional cul-
ture data, findings show that fa sting practice was influ-
enced by how the disciplines functioned together,
sometimes bringing them into conflict because they had
different objectives, ways of working and power bases.
... The fasting guidelines are... embedded in so
many different cultures that so many different
aspects of the organisation that they really are quite
difficult to change. (Trust R Anaesthetist PDSA
Facilitator)
There was a professional struggle over fasting practice
within Trusts. For example, one anaesthetist key contact
(Trust J) sent out emails to medical staff promoting
shorter fast times. Some of their colleagues replied this
is my theatre. Often, such behaviour resulted in nurses
being caught in the middle of variances in practice be-
tween anaesthetists.
Communication
Linked to inter-professional working, the nature and
quality of communication between individuals, teams,
and departments significantly impacted on fasting prac-
tice. In some trusts, communication between theatres
and wards about delays was considered good. In others
it was poor and seen as an area for improvement par-
ticularly with respect to revising and individualising fast-
ing times.
...Weve had a phone call from theatre to say this
patients been cancelled and you can feed and water
them. Half an hour later weve had a phone call saying
has she or he been fed and watered, she can go down
so theres been a big miscommunication or been told
completely wrong.... (Trust A Nurse, Focus group-SD)
Implementation context
The response rates to the Learning Organization Survey
were low (18% pre-intervention and 7.4% post-interven-
tion) and therefore findings interpreted with caution.
General features to emerge included that the organisa-
tions in this study were perceived to be highly struc-
tured, rule-based organisations. Over 50% of responders
did not feel innovative ideas were rewarded, and fewer
than 60% of the responders believed they are required to
upgrade and increase their knowledge. Less than 50% of
responders did not feel an integral part of their Trust.
Facilitation
Opinion leaders and PDSA facilitators within two inter-
vention arms had the potential to take on facilitation
roles (making things easier). In reality, the enactment
of these roles varied and linked to activities rather than
the model of facilitation/change agency of the interven-
tion. As such, fidelity to interventions was variable and
as a research team did not intervene in the intervention
Table 6 Summary of impact with examples
Impact Description
Policy changes and development Some trusts participating in the study had no Trust fasting policy. Some had fasting policies that were not
consistent with guideline recommendations. For these trusts, the intervention period included the
development of a policy (which in one Trust took six months to complete), and amending existing policy
to ensure it was with the guideline recommendations.
Changes to information given to
patients pre-operatively
Some trusts either developed or amended their patient information, including information provided in the
letters that were sent to patients pre-operatively to make it clear what time individual patients could eat
and drink up to (i.e., a move away from traditional block fasting rules), and what exactly terms such as
clear fluids meant.
Introducing new approaches to
communicating individual fasting times
Examples of different practical approaches to making patients and staff aware of the individual fasting
times were reported. For example, the use of various tools to mark/record individual patient fasting times,
such as paper cups, white boards and drug charts. Other practices included taking a more active approach
to encouraging patients to drink up to two hours before anaesthesia.
Improved communication Some staff reported that there had been improved communication between staff, and staff and patients
about fasting times (although communication was also highlighted as a barrier to changing practice in
some trusts).
Management of lists In some trusts it was reported that there had been a review of operational list management to attempt to
facilitate more individualised fasting times.
Raising awareness of fasting It was repo rted that the project raised practitioners awareness of fasting practice in their units
through infor mal and fo rmal education sessions, meetings, web-based resources, data collection, role
modelling.
Development of individuals A number of staff reported personal and professional development as a result of taking on key contact
and facilitator of PDSA roles.
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phase. Skills and attributes and activities are summarised
in Tables 7 and 8.
Summary
Whilst the research evidence underpinn ing fasting
recommendations was strong and relatively uncontested,
its translation into practice was challenging. Overall,
there was no significan t change to fluid and food fasting
times pre- and post-intervention and no significant dif-
ferences between the effectiveness of the three imple-
mentations. There were some significant decreases in
fluid fast times within trusts, but in two trusts there was
a significant increase in either fluid or fast times. These
data present a complex, but realistic picture of imple-
mentation within acute care settings where multiple
people, teams, and departments are involved.
Discussion
This study was a large and complex evaluation of imple-
mentation interventions within acute care, the findings
of which are relevant to the international community.
Evidence use can impact in different ways. The gap
between changing behaviour or practice, and how a
change in practice or behaviour then translates into a
change in (patient) outcomes is notoriously challenging
to achieve. Within this study, whilst we did not observe
significant positive changes to the primary outcome of
duration of fluid fasting, other types of impact were
achieved, which can be mapped along the continuum of
research use that includes changes to awareness, know-
ledge and understanding, attitudes, perceptions, ideas,
and practice and policy changes [44]. For example,
trusts involvement in the project had raised awareness
of the issue of fasting locally. Data also show that some
participants belie ved that attitudes and ideas towards
local fasting practice had shifted and that the project
had kick-started ideas. In some trusts, new policies and
procedures were developed and there were changes to
fasting practic e. However, these impacts were not
enough to result in changes to fasting outcomes over the
time period studied. Methodologically, if we accept that
evidence can have different types of impact, this raises
questions about how these should/could be captured
within implementation projects. There have been calls
Table 7 Skills and attributes of opinion leaders and facilitators
Attribute or skill Description
Authority Through their position (role) and their seniority they had the status and autonomy to influence
colleagues and decide how to do this. This attribute may have been particularly important in this study
where fasting practice was not particularly viewed as a clinical priority.
Credibility Often specified as clinical credibility, which in turn commanded respect of colleagues.
Drive, commitment, tenacity and enthusiasm To see the project through and keep motivated and motivate others.
Change management and practice
development skills, including:
These skills were seen as important for identifying facilitators and barriers, handling difficult situations,
understanding where people are coming from, and leadership in practice change. Both opinion
leaders and facilitators reported working with teams.
People management
Inter-professional working
Networking
Leadership
Education
Communication skills The ability to communicate well was perceived as contributing to the effectiveness of the skills and
attributes described above.
Table 8 Implementation activities
Activity How operationalised
Using existing structures or initiatives For example, adding a discussion of fasting times to pre-list theatre meetings introduced as part of The Health
Foundation Safer Patient Initiative or adding some information giving process (verbal or written) to pre-
assessment clinic appointments.
Dissemination of information Dissemination of the guideline to staff either on the intranet, via email or paper copies or the placement of
the algorithm poster on staff information boards.
Sharing examples of good practice Highlighting certain wards, departments and anaesthetists as role models.
Collection of local data Some trusts collected data on fasting and/or patients views of fasting (separate from their involvement in the
study).
Informal and formal education Using real time practice opportunities such as anaesthetic rounds to educate staff, and more formally through
education sessions and web tool use.
Identifying local leaders to work
with/delegate to
Identifying and working through others within trusts to lead on practice change such as anaesthetic nurses,
theatre co-ordinators, and surgical care practitioners.
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for ensuring that process evaluations are embedded
within trials [10], and this study demonstrates why
theory-led evaluation is important. Using theory facili-
tates a better understanding of impacts and outcomes,
including and understanding of what , why, and how [45]
Process data show that the most influential mediators
of practice change were inter-professional issues/ten-
sions and communication, and a lack of clarity for the
authority and responsibility for local fa sting de cisions
(e.g., when operating lists changed). These issues were
evident irrespective of the allocation to intervention. The-
oretically, the PDSA intervention had the potential to
diagnose and ameliorate these issues, however within this
study facilitator activities undertaken were more project
related (e.g., arranging education meetings) than process
orientated (e.g., teambuilding) [46,47]. Future change
strategies in this area of practice would benefit from a
focus on effective team working. More generally, there is
still much to learn about what good enough facilitation is,
and what might work in different situations.
Theoretically, we had anticipated that more active
interventions might have a greater impact than a passive
strategy alone. Our findings suggest the effect size of the
more active interventions compared to SD alone is
small, thus supporting previous assertions that passive
and simple interventions, may be as effective as active,
and multi-faceted ones [10]. However, process data pro-
vide some more explanation. Closer analysis of the trust
that made the greatest change to fasting times, for ex-
ample, shows they were disappointed to have been allo-
cated to SD, there was an existing commitment by the
hospital to reduce fasting times, there was targeted and
active dissemination of the guideline to relevant parts of
the organisation, a number of key stakeholders took a
leadership role in championing the issue, and the key
contact led on multiple implementation related activ-
ities. These findings are supported by published studies
showing that strategic buy-in, leadership, and active
strategies may all be essential ingredients for successful
implementation [31,48,49].
As researchers, our ability to control intervention and
implementation activities in this study was limited. The-
oretically, the interventions were standardised in that all
were packaged and appropriate training provided. How-
ever, in reality, there was variability in the starting points
of trusts (e.g., some had no fasting policy), and therefore
a difference in how different compon ents of the inter-
ventions were implemented. For example, all PDSA
intervention trusts had a start-up meeting, but not all
continued to meet regularly throughout the intervention
period as pl anned in the intervention package because
of difficulties securing time away from practice. There-
fore, within this study there are important questions
about intervention fidelity and whether relevant staff
and departments had insufficient exposure to the imple-
mentation interventions. However, there are questions
to ask about if, and how, you could control activities in
studies that are undertaken in the reality of complex and
unpredictable clinical environment s where researchers
are working at arms length with local clinical/research
communities. Hawe et al. [50] suggest we pay attention
to the function and process of the intervention, rather
than the standardisation of the intervention components
themselves. Identifying the essential functions of an
intervention, for example, facilitation, and examining the
evidence for a fit with the theory of facilitation would
provide an alternative perspective on standardisation
and fidelity.
Within this study, some theoretical integrity was
achieved by applying a theoretical framework that
guided implementation intervent ion development, evalu-
ation activities and for providing explanation. As out-
lined earlier, the underlying theory of PARIHS is that SI
= f(E,C,F). If we test the proposition with the findings of
this study, the component that does not stand up to
scrutiny is evidence. Fasting practice has a robust re-
search evidence base, which was generally accepted by
those participating in this study. Previous research has
indicated that where there is strong research evidence,
about which there is clinical consensus it is more likely
to be used in practice [17,18]. In this study, the mediat-
ing effect of context (particularly the effect that teams
and professional groups had on operating list manage-
ment) was stronger, and facilitative activities used in this
study did not overcome these.
Limitations
The interrupted time series did not have all data at all
timepoints for all trusts, mainly due to the delays in get-
ting research governance approval from participating
Trusts. However, because there were no significant time
trends pre-or post-intervention, and thus all four pre-
and all four post-timepoints were combined, the impact
of this missing data was minimised.
The primary outcome wa s duration of fluid fast prior
to induction of anaesthesia. This together with food fast
time was collected by the local investigator asking
patients when they last drank and ate, supported by data
in patients notes. It is possible the times recorded were
not always recalled or recorded completely accurately.
The intervention period was six months, which limited
the amount of activity that was possible before post-
intervention outc ome data was collected. The four post-
intervention timepoints did not show any trends over
time, suggesting that a longer intervention period may
not have led to improved fasting times. However, evi-
dence is lacking about how long an intervention period
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is needed to make changes to practice and service deliv-
ery, particularly ones that sustain.
The size of this study19 Trusts split over three inter-
vention groupsmay be seen as a limitation. The study
was designed to be adequately powered to detect an ef-
fect size that was large because the evidence available at
the time of designing the trial suggests fluid fasting
times are far too long and would need to reduce sub-
stantially more for the intensive intervention than by SD
if the effort required was to have an impact on fluid fast-
ing time that was beneficial to patients.
As a cluster trial, to have a substantial impact on the
power of the study would require additional Trusts, not
simply more observations within the existing Trusts.
However, to recruit and maintain Trusts in a study of
this type is complex, costly, and very time-onsuming.
The evidence from surveys suggests that fluid fasting
times have not substantially decreased since the guide-
lines were published and disseminated in 2004 [39,40];
thus, our assumption that fluid fasting time needs to
substantially reduce is still supported by other studies.
Whilst it is important in designing studies to be realistic
about the effect size that can be achieved, we also need
to strive to detect effects of clinical worth not simply
those that are statistically significant. The more intensive
interventions considered in this study would need to
show a substantial reduction in fluid fasting time beyond
that of SD to be of noticeable benefit to patients.
Intervention fidelity was difficult to ensure and evalu-
ate. We were aware that different teams implemented
their intervention in different ways, and we attempted to
capture this through the process evaluation. For example,
some PDSA groups appeared to follow the process closely,
others were less engaged and followed it in a more ad hoc
manner. T hus, the intervention dose is likely to be differ -
ent between the groups. As a pragmatic RCT, tailoring of
interventions is a recognised component [51] and viewed
as making the intervention more feasible to implement in
the real world.
Conclusions
This study is one of the first national RCTs with an em-
bedded process e valuation conducted within acute care
in the field of implementation research. Evaluating im-
plementation in the context of fasting practice provided
a useful vehicle with which to expose some of the gen-
eral issues and challenges faced when implementing evi-
dence into practice. The issues uncovered in this study
have important international implications because they
have helped to further articulate the complex processes
embedded in implementation as well as its evaluation.
There are a set of conditions and antecedents for im-
plementation that emerge from the findings of this
study, which we have developed into a number of
propositions:
1. Implementation is more likely to be successful in
cases where the topic/issue is a strategic and
organisational priority. If the issue is not a priority,
the active engagement of individuals and
departments is mediated by for example, a lack of
dedicated human and financial resource, and
resultant implementation will be patchy.
2. A historical lack of clear leadership, structure, and
process for local guideline dissemination and
implementation, in which staff are unclear about
their responsibilities, will negatively impact on an
organisations ability to routinely use guideline
recommendations.
3. Robust and believable evidence is not always
sufficient to change decision making and practice,
therefore implementation interventions and efforts
need to extend beyond individual decision making (at
least for certain clinical topics) and take account of
the systemic interconnections betwe en individuals,
teams and organisations.
4. In areas where there is more effective teamwork with
clear communication, practice change will be easier
to achieve.
5. New improvement and implementation projects have
a higher chance of success if they are embedded into
existing programmes and structures.
6. Change agen t effectiveness is a function of the
protected space and dedicated time to fulfil the role,
i.e., it has to be part of the day job.
7. Change agen ts will be more effective if they have
people management skills, work collaboratively,
handle difficult situations and people with diplomacy,
understand where people are coming from, develop
and motivate a team, including effective and
considerate delegation of work, using team members
skills well. This is a skilled role at which some excel,
and some find more challenging.
8. Evaluations of implementation interventions that
capture different types of impacts over the course of
the study/programme are more likely to provide a
realistic picture of knowledge use, and intended and
unintended consequences. Clearly, how one proceeds
to evaluate these impacts will be dependent on the
definition of knowledge and use.
9. Complex interventions such as implementation
interventions need to be deconstructed to gain a
greater understanding of the linkages between the
active components/mechanisms of action and the
impact on both process and summative outcomes.
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It is likely that these propositions will be theo retically
transferable to other implementation studies, particularly
when considered alongside the growing empirical and
theoretical evidence base about the successful ingredi-
ents for successful implementation.
Additional files
Additional file 1: Table S1. Data recording sheet for fasting time.
Additional file 2: Table S2. Digitally read patient experience
questionnaire.
Additional file 3: TableS3. Cost analysis.
Competing interests
The authors declare they have no competing interests.
Authors' contributions
JRM conceived the study, and led the design of the study with KS, IB, and
NC. JRM, KS, and IB secured funding. JRM supervised all aspects of the study,
with input from KS. IB supervised the cost consequence analysis. NC led and
conducted the quantitative data analysis. JC and CH coordinated and took
the lead role in data collection and analysis, and commented on drafts of
the paper. CA provided a patient perspective throughout the conduct of the
study including the development of patient related materials and data
collection processes. LS provided a clinical perspective on the project as an
anaesthetist. JRM drafted the paper, KS, NC, and CH wrote sections of the
paper and KS, CH, JC, CA, IB commented and approved the final manuscript.
Acknowledgements
The authors gratefully acknowledge funding of this research from The Health
Foundations Engaging with Quality Initiative. Results and opinions expressed
are those of the investigators and do not necessarily reflect the opinion or
policies of The Health Foundation. We also wish to thank the many local
investigators, change agents and patients that took part in this study: Sarah
Davis (working at National Clinical Guidelines Centre for Supporting Care at
the time of the study) for conducing the economic analysis; and Ross
Scrivener (RCN) for his support with the development of the web-based
resource, including training.
Author details
1
Centre for Health Related Research, School of Healthcare Sciences, Bangor
University, Ffriddoedd Road, Bangor, UK.
2
RCN Research Institute, School of
Health and Social Studies, Warwick University, Coventry, UK.
3
Faculty of
Health and Social Care, London South Bank University, London, UK.
4
Cochrane Collaboration, Summertown Pavilion, Oxford, UK.
5
National Clinical
Guideline Centre (NCGC), Royal College of Physicians, St Andrews Place,
London, UK.
6
former President of the Royal College of Anaesthetists, London,
UK.
Received: 16 November 2011 Accepted: 27 August 2012
Published: 30 August 2012
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Cite this article as: Rycroft-Malone et al.: A pragmatic cluste r randomised
trial evaluating three implementation interventions. Implementation
Science 2012 7:80.
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    • "However, prospective studies remain limited. One exception to this is a prospective study on peri-operative fasting, which used PARIHS to design a pragmatic trial to test the effectiveness of the introduction of guidelines to improve practice [12, 17]. From their analysis, the authors suggested that an additional weakness in the framework was the failure to acknowledge the central role of individuals in determining the process and outcomes of implementation , mediated through individual interactions with and influence on the evidence and context dimensions of PARIHS. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: The Promoting Action on Research Implementation in Health Services, or PARIHS framework, was first published in 1998. Since this time, work has been ongoing to further develop, refine and test it. Widely used as an organising or conceptual framework to help both explain and predict why the implementation of evidence into practice is or is not successful, PARIHS was one of the first frameworks to make explicit the multi-dimensional and complex nature of implementation as well as highlighting the central importance of context. Several critiques of the framework have also pointed out its limitations and suggested areas for improvement. Discussion: Building on the published critiques and a number of empirical studies, this paper introduces a revised version of the framework, called the integrated or i-PARIHS framework. The theoretical antecedents of the framework are described as well as outlining the revised and new elements, notably, the revision of how evidence is described; how the individual and teams are incorporated; and how context is further delineated. We describe how the framework can be operationalised and draw on case study data to demonstrate the preliminary testing of the face and content validity of the revised framework. Summary: This paper is presented for deliberation and discussion within the implementation science community. Responding to a series of critiques and helpful feedback on the utility of the original PARIHS framework, we seek feedback on the proposed improvements to the framework. We believe that the i-PARIHS framework creates a more integrated approach to understand the theoretical complexity from which implementation science draws its propositions and working hypotheses; that the new framework is more coherent and comprehensive and at the same time maintains it intuitive appeal; and that the models of facilitation described enable its more effective operationalisation.
    Full-text · Article · Dec 2015 · Implementation Science
    • "These provided an initial framework with which to synthesize the purposively selected texts, which involved annotation, extraction and theming to develop the framework of core concepts. Applying the core concept framework The findings of a cluster-randomized controlled trial to evaluate implementation strategies to address the practice of prolonged fasts before routine surgery included an embedded process evaluation described in full elsewhere (Rycroft-Malone et al. 2012, 2013). A key evidence-based recommendation specifies nil by mouth before induction of anaesthesia should be at 2 hours (RCN/RCoA 2005). "
    [Show abstract] [Hide abstract] ABSTRACT: AimTo examine the application of core concepts from Complexity Theory to explain the findings from a process evaluation undertaken in a trial evaluating implementation strategies for recommendations about reducing surgical fasting times.Background The proliferation of evidence-based guidance requires a greater focus on its implementation. Theory is required to explain the complex processes across the multiple healthcare organizational levels. This social healthcare context involves the interaction between professionals, patients and the organizational systems in care delivery. Complexity Theory may provide an explanatory framework to explain the complexities inherent in implementation in social healthcare contexts.DesignA secondary thematic analysis of qualitative process evaluation data informed by Complexity Theory.Method Seminal texts applying Complexity Theory to the social context were annotated, key concepts extracted and core Complexity Theory concepts identified. These core concepts were applied as a theoretical lens to provide an explanation of themes from a process evaluation of a trial evaluating the implementation of strategies to reduce surgical fasting times. Sampled substantive texts provided a representative spread of theoretical development and application of Complexity Theory from late 1990's–2013 in social science, healthcare, management and philosophy.FindingsFive Complexity Theory core concepts extracted were ‘self-organization’, ‘interaction’, ‘emergence’, ‘system history’ and ‘temporality’. Application of these concepts suggests routine surgical fasting practice is habituated in the social healthcare system and therefore it cannot easily be reversed. A reduction to fasting times requires an incentivised new approach to emerge in the surgical system's priority of completing the operating list.Conclusion The application of Complexity Theory provides a useful explanation for resistance to change fasting practice. Its utility in implementation research warrants further attention and evaluation.
    No preview · Article · Sep 2015 · Journal of Advanced Nursing
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    • "We intend to extend our evaluation of factors that may impact on implementation by conducting a process evaluation alongside the trial. The process evaluation, informed by the Promoting Action on Research Implementation in Health Services (PARIHS) framework [38], will follow a similar design to that used in a cluster trial in acute care considering the interplay between the intervention, local experience, the PICU context and the implementation process [39]. This will reveal how the sedation and ventilation weaning protocols were received within PICUs, any observed local issues, how the implementation processes performed and the impact on the trial outcomes. "
    Full-text · Article · Jul 2015 · Trials
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