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Implementing training and support, financial reimbursement, and referral to an
internet-based brief advice program to improve the early identification of
hazardous and harmful alcohol consumption in primary care (ODHIN): study
protocol for a cluster randomized factorial trial
Implementation Science 2013, 8:11doi:10.1186/1748-5908-8-11
Myrna N Keurhorst (firstname.lastname@example.org)
Peter Anderson (email@example.com)
Fredrik Spak (firstname.lastname@example.org)
Preben Bendtsen (email@example.com)
Lidia Segura (firstname.lastname@example.org)
Joan Colom (email@example.com)
Jillian Reynolds (firstname.lastname@example.org)
Colin Drummond (Colin.email@example.com)
Paolo Deluca (Paolo.firstname.lastname@example.org)
Ben Steenkiste (email@example.com)
Artur Mierzecki (firstname.lastname@example.org)
Karolina K¿oda (email@example.com)
Paul Wallace (firstname.lastname@example.org)
Dorothy Newbury-Birch (email@example.com)
Eileen Kaner (firstname.lastname@example.org)
Toni Gual (email@example.com)
Miranda GH Laurant (firstname.lastname@example.org)
18 November 2012
22 January 2013
24 January 2013
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© 2013 Keurhorst et al.
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Implementing training and support, financial
reimbursement, and referral to an internet-based
brief advice program to improve the early
identification of hazardous and harmful alcohol
consumption in primary care (ODHIN): study
protocol for a cluster randomized factorial trial
Myrna N Keurhorst1*
* Corresponding author
Ben van Steenkiste8
Miranda GH Laurant1
1 Radboud University Nijmegen Medical Centre, Scientific Institute for Quality
of Healthcare (IQ healthcare), P.O. Box 9101, 114 IQ healthcare, 6500 HB
Nijmegen, The Netherlands
2 Institute of Health and Society, Medical Faculty, Baddiley-Clark Building,
Richardson Road, Newcastle upon Tyne NE2 4AX, United Kingdom
3 Department of Social medicine, University of Gothenburg, P.O. Box 453, 405
30 Gothenburg, Sweden
4 Department of Medicine and Health, Linköping University, 581 83 Linköping,
5 Program on Substance Abuse, Public Health Agency, Government of Catalonia,
6 Hospital Clínic de Barcelona, Addictions Unit, Institut Clínic de
Neurosciències, C/Villarroel 170, CP 08036 Barcelona, Spain
7 Addictions Department, National Addiction Centre, Institute of Psychiatry,
King’s College London, 4 Windsor Walk, London SE5 8BB, UK
8 Department of General Practice, Maastricht University, School CAPHRI, P.O
Box 616, 6200 MD Maastricht, The Netherlands
9 Independent Laboratory of Family Physician Education, Pomeranian Medical
University in Szczecin, ul. Rybacka 1, 70-204 Szczecin, Poland
10 Department of Primary Care and Population Health, University College
London, London, UK
The European level of alcohol consumption, and the subsequent burden of disease, is high
compared to the rest of the world. While screening and brief interventions in primary
healthcare are cost-effective, in most countries they have hardly been implemented in routine
primary healthcare. In this study, we aim to examine the effectiveness and efficiency of three
implementation interventions that have been chosen to address key barriers for improvement:
training and support to address lack of knowledge and motivation in healthcare providers;
financial reimbursement to compensate the time investment; and internet-based counselling
to reduce workload for primary care providers.
In a cluster randomized factorial trial, data from Catalan, English, Netherlands, Polish, and
Swedish primary healthcare units will be collected on screening and brief advice rates for
hazardous and harmful alcohol consumption. The three implementation strategies will be
provided separately and in combination in a total of seven intervention groups and compared
with a treatment as usual control group. Screening and brief intervention activities will be
measured at baseline, during 12 weeks and after six months. Process measures include health
professionals’ role security and therapeutic commitment of the participating providers
(SAAPPQ questionnaire). A total of 120 primary healthcare units will be included, equally
distributed over the five countries. Both intention to treat and per protocol analyses are
planned to determine intervention effectiveness, using random coefficient regression
Effective interventions to implement screening and brief interventions for hazardous alcohol
use are urgently required. This international multi-centre trial will provide evidence to guide
ClinicalTrials.gov. Trial identifier: NCT01501552
Alcohol, Screening, Brief interventions, Primary healthcare, Training and support, Financial
reimbursement, Internet, Implementation
The European Union (EU) has the highest alcohol consumption of the world: in 2009, the
average adult (aged 15+ years) alcohol consumption in the EU was 12.5 litres of pure alcohol
. A review showed that consumption above 20 to 30 grams of alcohol a day (two to three
glasses of wine) increases an individual’s risks of mortality and morbidity [2,3]. However,
people often overestimate the positive health effects of alcohol; in fact, only small amounts of
alcohol have positive effects on health [2,3].
Alcohol consumption is the third world leading cause of diseases and premature death .
The costs related to alcohol are €
justice sectors as a consequence of alcohol-attributable disease, injury, and violence .
Therefore, individuals and society would benefit from effective preventive measures with
respect to morbidity and mortality and social costs.
?????? ?? ? ? ??? ?? ??????lfare, employment, and criminal
There is considerable evidence showing that early identification of hazardous and harmful
alcohol consumption result in reduced alcohol consumption and improved health outcomes.
Primary healthcare (PHC) is the primary point of contact for many people seeking healthcare.
In this setting, screening  and brief intervention programs have proven to be effective in
reducing alcohol consumption [6-10], with a mean reduction of 38 grams of alcohol per week
(three to four glasses of wine) . Although the evidence is still inconsistent about positive
effects of nurse-led interventions [11,12], generally screening and brief interventions are
provided by healthcare workers such as GPs, nurses, or psychologists . The number
needed to treat (NNT) in offering screening and brief interventions is eight (for every eight
people treated one will change their behaviour) , which is relatively low compared to
smoking cessation, which has a NNT of around 35 or higher . Despite the evidence for
efficacy and cost-efficacy of screening and brief interventions in PHC, these interventions are
rarely implemented in routine practice . Commonly, less than 10% of the population at
risk are identified, and less than 5% of those who could benefit are offered screening and
brief interventions in PHC settings .
Some of the reasons for this gap are identified and can be categorised in three main domains.
First, evidence suggests there is substantial lack of knowledge among general practitioners
(GPs) [5,16]. A survey across 13 countries found that one-third of all GPs reported never
receiving alcohol-related education, 23% reported less than four hours, and 37% reported
more than seven hours of alcohol-related education ever . A recent update from England
has shown that 52% of the United Kingdom’s surveyed GPs indicated that they had received
less than four hours of post-graduate training, continuing medical education, or clinical
supervision on alcohol and alcohol related problems . Furthermore a lack of role security
and therapeutic commitment has been identified .
Secondly, lack of adequate resources and support are identified as important barriers [16,20].
Financial incentives could be important measures to overcome this barrier, but as far as we
know, there have been no randomised controlled trials conducted investigating the impact of
reimbursement for alcohol screening and brief interventions in the PHC setting.
The third important barrier relates to time constrains in terms of perceived workload and
work pressure for screening and brief intervention activities . In PHC, trained nurses are
increasingly involved in preventive care activities and in the management of chronic ill
patients due to the increased workload of GPs. It has shown that they provide safe and
effective care . This study focuses on all healthcare professionals working at primary
healthcare units (PHCUs).
Although previous implementation studies [22,23] have tried to increase screening and brief
interventions in primary healthcare, the gap between scientific knowledge and everyday
clinical practice remains . With regard to the first category of barriers of knowledge and
attitude, earlier studies found that training and support could make GPs even less secure in
their work with drinkers, when the training and support does not address prior GP’s attitude
in the training and support [15,19]. In the ODHIN study, we will tailor our implementation
strategy to the primary healthcare worker’s prior attitude. With regard to the second category,
lack of resources, there are mixed results of evidence of finance systems to change provider
behaviour [25,26]. There is limited evidence that finance systems can change provider
behaviour of screening and brief interventions of alcohol . Still, financial incentives for
smoking cessation interventions have shown a significant positive outcome on increases in
referral to tobacco cessation services , and suggest financial support for alcohol
interventions might be effective. In the third category, workload and work pressure, we
suggest e-health interventions might be of benefit. E-self help interventions without therapist
support are available both in brief and more extended formats and have shown to be effective
in reduction of alcohol consumption . Additionally, internet interventions with therapist
support focused on depression and anxiety were found to have larger effect sizes compared to
internet interventions without therapist support , but has not yet been tested for alcohol
internet interventions. These e-health interventions might be helpful to reduce workload of
healthcare professionals after identification of patients at risk as well as availability for
patients 24 h a day. Therefore, it is of interest to test if primary healthcare workers’ referral to
internet-based brief interventions, hereafter termed e-BI, could be time-saving for healthcare
professionals and consequently might raise primary care worker’s intervention activity.
It is of significant public health interest to explore, and optimize, effective implementation
strategies to improve PHC activities in screening and brief interventions for hazardous and
harmful alcohol consumption. In the current study, we evaluate the effect of three strategies,
each aimed to tackle one of the above reported barriers, singly or in combination, in order to
overcome the gap between knowledge and daily practice.
Aim and objectives
Our aim is to study the effectiveness of training and support (T&S), financial reimbursement,
and internet based brief interventions (e-BI), targeted singly or in combination to primary
healthcare units, on screening and brief intervention activities, compared to treatment as
usual. The following hypotheses will be tested in the study:
1. Provision of training and support to primary healthcare providers will increase use of
preventive screening and brief interventions compared to a care as usual control group.
2. Financial reimbursement to primary healthcare providers as a pay-for-performance of brief
alcohol interventions will increase screening and brief intervention rates compared to care
3. Providing resources, i.e., offering referral possibility to an internet-based method of
delivering brief intervention, will increase screening and brief intervention rates compared
to care as usual.
4. The combination of training and support, financial reimbursement, and e-BI will be more
effective in increasing screening and brief intervention rates compared to single-focused
Our study is designed as a cluster randomized factorial trial. Data from PHCUs in Catalonia,
England, the Netherlands, Poland, and Sweden will be combined to examine the effect of
three different implementation strategies singly or in combination on screening and brief
advice rates for hazardous and harmful alcohol consumption compared with care as usual
(controls). In all countries, the complete trial will be conducted between August 2012 and
PHCUs with approximately 5,000 to 20,000 registered patients will be the unit of
randomization and implementation. In Poland, because practitioners normally operate as
single-handed entities working with other practitioners in one building, three practitioners
and their staff working in one building will be the unit of randomization. PHCUs who agree
to participate in the study are volunteers that will be drawn from administrative or academic
registries of PHCU at national or regional levels. PHCUs that have current ongoing alcohol-
related projects that have a focus on screening and brief interventions, involve GPs and/or
nurses, and include one of the ODHIN implementation strategies, will be excluded.
Besides fully-trained GPs, nurses or practice assistants with a permanent appointment
working in the PHCU and involved in medical and/or preventive care are also eligible,
because they also have skills to assist in screening and brief interventions [12,30,31]. At the
start of the study, all eligible providers within the PHCU will be identified by the research
team. Participating providers are those eligible providers who agree to participate in the trial.
Before baseline measurement, the participating providers have to sign up for the study,
allowing PHCU with a high number of staff to include only a selection of staff. Staff not able
to attend this meeting but willing to participate will be informed by the contact person in the
PHCU. These providers will also sign an informed consent for their participation. In the
Netherlands, England, Poland and Sweden, PHCU will receive a trial fee. The trial flow chart
is shown in Figure 1.
Figure 1 Trial flow chart. Myrna → allocation nog aanpassen: hokjes iets groter. Financial
niet afkorten…. Nu valt tekst weg. Lijn onder alle groepen en vandaaruit pijl naar beneden en
vervolgens allen van de verticale pijl een pijl horizontaal naar N PHCU/providers lost to
The implementation period will last twelve weeks, with the start date for each country
between November 2012 and March 2013. The start date of the implementation period for
each PHCU will be staggered. Implementation strategies are outlined in detail in Table 1. All
groups will receive the same input as controls but with additional components added. These
strategies are about to be tested singly or in combination:
1. Control group, treatment as usual
3. Financial incentives
5. T&S and financial incentives
6. T&S and e-BI
7. Financial incentives and e-BI
8. T&S, financial incentives, and e-BI
Table 1 Outline of intervention groups with three different implementation strategies
1. Control Group—treatment as usual: The control group will receive a package, either hand-
delivered or by post, containing a summary card of the national guideline recommendation
for screening and brief advice for hazardous and harmful alcohol consumption, without
demonstration. In Poland, where no national guidelines exist, the summary card will be
adapted from the PHEPA guidelines for the purposes of this trial . No further
instructions will be given.
2. Training and support: Countries differ largely with regard to usual T&S and other
educational training of primary care staff. To maximise comparability, a set of minimal and
maximal criteria have been established, in which each country specific T&S package
In addition to receiving the same package as the control group, the T&S group will be
offered two initial 1 to 2 hours face-to-face educational trainings, and one (10 to 30 min)
telephone support call to the lead PHCU contact person during the twelve week
implementation period. If necessary, one additional face-to-face training of 1 to 2 h
duration will be offered. The time intervals between the initial training, the telephone call,
and the additional optional training will be, on average, two weeks. The training addresses
knowledge, skills, attitudes, and perceived barriers and facilitators in implementing
screening and brief advice, combining theory and practical exercises. The location of the
educational training will vary from country to country and include in-house meetings at the
PHCU or within clusters of PHCUs. The trainers will include peer trainers, members of the
research team, accredited teachers, or addiction consultants. Each country will use an
adapted existing country-based T&S package. In the case of Poland, the T&S package will
be based on the PHEPA training program.
3. Financial incentives: In addition to receiving the same package as the control group,
financial incentive groups will be paid for their registered screening and brief intervention
activities. Payment depends on normal country specific fees and rates for financial
incentives for clinical preventive activities.
4. e-BI: In addition to receiving the same package as the control group, the e-BI group will be
asked to refer identified at risk patients with an e-leaflet with unique log in codes to an
approved e-BI specific package, which will be country specific, or, for Poland based on the
WHO e-SBI program. The website should include the following: Log-in facility to allow
monitoring of the patient (i.e., patient actually log-in); suitable brief screening tool with
ability to calculate score and give feedback (i.e., brief intervention); appropriate
information on sensible drinking guidelines; information on impact of alcohol on health
and wellbeing; and a drink diary facility. Furthermore, the website could offer reminder
facilities for follow-up activity.
5. T&S and financial incentives: The T&S and financial incentive group will receive the
package, T&S, and the financial incentives as described above.
6. T&S and e-BI: The T&S and e-BI group will receive the package, T&S as above, and will
be asked to refer identified at risk patients to e-BI as above.
7. Financial incentives and e-BI: The financial incentive and e-BI group will receive the
package and will be asked to refer identified at risk patients to e-BI as above. They will be
paid for screening, referral performance to e-BI, and brief advice if actually delivered, with
the system of pay as above.
8. T&S, financial incentive and e-BI: The T&S, financial incentive and e-BI group will
receive the package and T&S as above. They will be asked to refer identified at risk
patients to e-BI as above. They will be paid for screening, brief advice activities, and
referral performance to e-BI, with the system of pay as above.
A graphical depiction of the study is depicted in Additional file 1.
An introductory meeting (first briefing) will be held in all PHCUs that agree to participate in
the study, describing the study’s purpose and the four-week baseline data collection, which
will follow the introductory meeting. After the baseline data collection, all PHCUs will
receive a second briefing within one month, either face to face or by telephone, tailor-made to
the study group to which they are allocated.
Primary outcomes: screening and brief advice rates
PHCUs will be asked to screen all patients aged 18 years and over who attended the PHCU.
These patients are defined as eligible patients.
Patients will be screened for hazardous and harmful alcohol consumption with AUDIT-C
. Screen positives, or at risk patients, are defined as those who scored ≥5 for men or ≥4
for women on AUDIT-C. Participating staff that have signed up to the study will be asked to
deliver brief alcohol advice of 5 to 15 min duration to at-risk patients, with the length and
format of the brief advice based on country-specific guidelines or, for Poland where national
guidelines are lacking, the European guidelines developed by PHEPA . Providers of
PHCUs allocated to e-BI activity will be asked to refer patients to a computerized brief
advice program, considered equivalent to providing brief advice. Besides counting referral
rate to e-BI, actual e-BI log-in rates of patients will be collected.
Screening and brief advice will be measured at five timepoints: during the four-week baseline
period, the three consecutive four-week blocks during the twelve week implementation
period; and, the four-week follow-up period, which will occur during the seventh month after
the end of the twelve-week implementation period using paper tally sheets, with the
exception of Catalonia who will use their electronic patient records. The tally sheets include
AUDIT-C scores (i.e., identification of at risk patients) with additional table to indicate the
type of brief advice that was delivered to the patients at risk. Gender and age of patients will
be recorded as well as the name and profession of the provider.
The screening rate will be calculated as the number of completed screens divided by the total
number of consultations of all patients eligible for screening (as defined above) per
participating provider times 100. The brief advice rate will be calculated as the number of BIs
delivered (received oral brief advice, and/or were given an advice leaflet, and/or were
referred to the e-BI program, and/or were referred to another provider in or outside the
practice), divided by the total number of screen positives per participating provider times
100. Information will also be collected on the number of screen negatives who received brief
Screening and brief advice rates will be calculated at two levels: at an aggregate PHCU level
for all participating providers in the PHCU; and, at an individual provider level for each
participating and actively participating providers. Participating providers are defined as those
who attended the first briefing, or who were identified as joining the study by the contact
person of the PHCU at the first briefing. Actively participating providers are defined as those
participating providers who completed at least one tally sheet or computerized record during
one of the measurement periods.
Secondary outcomes: role security and therapeutic commitment
Role security and therapeutic commitment of the participating providers will be measured by
the short version of the Alcohol and Alcohol Problems Perception questionnaire (SAAPPQ)
 at three time points: at or immediately after the first introduction meeting, at the end of
the 12-week implementation period, and during the end of the four-week follow-up period.
All participating providers who have signed an informed consent will be asked to complete
the SAAPPQ at each of the three time points. The responses will be summed within the two
scales of role security and therapeutic commitment. Individual missing values for any of the
items in a domain will be assigned the mean value of the remaining items of the domain
Randomization and blinding
Randomization will take place after formal agreement of the PHCU to take part in the trial.
The PHCU will be randomly allocated to one of eight groups by the European coordinating
centre, using computerized randomization stratifying by country, ensuring 15 PHCUs per
group (three per country). Although the PHCUs will be randomly allocated before the
baseline measurement, the research team in each of the countries and the PHCU only are
informed of the allocation after collection of the baseline measurement to avoid bias as a
result of group allocation. For the remainder of the study period, the PHCU and investigators
will not be blind to group allocation.
It is estimated that 56 PHCUs (seven per eight allocation groups) with a minimum of 1,000
eligible patients per month would be needed for a 80% chance of detecting an increase in
screening rates from 8% to 12% (ICC = 0.029) and that 120 PHCUs (15 per eight allocation
groups) would be needed for a 80% chance of detecting an increase in brief advice rates from
4% to 6% (ICC = 0.029) (alpha = 5%). As country is used as stratification criteria each
country has to include a minimum of 24 PHCUs. These conservative estimates are based on
published evidence of screening and advice rates [22,23].
Because of the hierarchical structure of the data (individual providers nested within PHCU
nested within country), we will perform multilevel analyses of the screening and advice rates
to examine the effect of the implementation strategies in comparison with the controls. The
intention to treat analyses will include all participating providers (see above). Per protocol
analyses will include only actively participating providers (see above). In all the analyses, we
will use exposure to the implementation strategy as co-variate. Exposure is defined as
positive if the providers meet the following criteria: financial—the PHCU received the
financial incentive; e-BI—the provider handed out at least one referral card; and T&S—the
provider attended the two face-to-face educational meetings. If these criteria will not be met,
the exposure will be defined as negative.
Analyses will be performed in SAS V9.2 and based on mixed effects model (PROC
GLIMMIX and PROC MIXED). We will use a random intercept model with fixed variables.
By conducting this trial, we are trying to address the well-known implementation gap
(evidence to practice) of screening and brief interventions for hazardous and harmful alcohol
consumption in PHC. For example, researchers rarely have been in a position to actively
compare a number of incentive-based strategies. With this trial, we aim to assist in building a
knowledge base, on which policy could be based on.
We are aware of some strengths and limitations of this trial. This trial is approached
pragmatically. In other words, each of the five countries differs slightly in the implementation
strategy contents. For example, countries will differ in their distribution of research fees,
amount of financial reimbursements, and deliverers of training and support strategies. The
research team explicitly determined this pragmatic approach, because they considered this
approach being most valuable for country policy makers. Albeit, in terms of research, this is
less powerful because there are small variations in implementation strategies per country.
The five participating countries are different in their organization of primary care and have
different drinking patterns. This creates opportunities to conduct across-country analyses and
relate different implementation rate outcomes to cultural and organizational differences.
These results can consequently be applicable through Europe and other similar Western
countries. In the future, if our implementation strategies result in improved screening and
brief intervention rates, other countries with comparable primary care systems could use
these strategies to improve the prevention of hazardous and harmful alcohol consumption in
e-BI, Internet based brief interventions; PHC, Primary healthcare; PHCU, Primary healthcare
unit; SAAPPQ, Short Alcohol and Alcohol Perceptions Questionnaire; T&S, Training and
The authors declare that they have no competing interests.
MK, PA, and ML wrote the first draft of the manuscript and all other authors revised the
manuscript critically. PB, FS, and PA were responsible for the original set up of the study
design, which has further been discussed with all authors during three meetings. The final and
in this paper presented design is the outcome of these discussions and written comments of
all authors. All authors read and approved the final manuscript.
The research leading to these results or outcomes has received funding from the European
Community’s Seventh Framework Program (FP7/2007-2013), under Grant Agreement nº
259268 – Optimizing delivery of healthcare intervention (ODHIN). Participant organisations
in ODHIN can be seen at: www.odhinproject.eu.
Radboud University Nijmegen Medical Centre received co-funding from The Netherlands
Organisation for Health Research and Development (ZonMW, Prevention Program), under
Grant Agreement nº 200310017 – ODHIN – Optimizing delivery of healthcare interventions
in the Netherlands, according Art.II.17 of the FP7 EC Grant Agreement.
The following individuals were part of the WP5 ODHIN group, besides the authors of this
study protocol: Begoña Baena (Spain), Amy Wolstenholme (UK) , Marcin Wojnar (Poland),
Katarzyna Okulicz- Kozaryn (Poland), Krzysztof Brzózka (Poland), Luiza Slodownik
(Poland), Gaby Ronda (Netherlands), Trudy van der Weijden (Netherlands), Michel Wensing
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