Partner randomized controlled trial: Study protocol and coaching intervention

Article (PDF Available)inBMC Pediatrics 12(1):42 · April 2012with23 Reads
DOI: 10.1186/1471-2431-12-42 · Source: PubMed
Abstract
Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured. Twenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

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STUDY PROT O C O L Open Access
Partner randomized controlled trial: study
protocol and coaching intervention
Jane M Garbutt
1,2,5*
, Gabrielle Highstein
3
, Yan Yan
4
and Robert C Strunk
1
Abstract
Background: Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent
care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns
or problems with management, or provide self-management education. Effective interventions to improve asthma care
such as small group training and care redesign have been difficult to disseminate into office practice.
Methods and design: This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-
month telephone-coaching program designed to support primary care management of children with persistent
asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care
events for asthma care. Randomization occurred at the practice level with eligible families within a practice having
access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical
model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use
of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with
education and support for asthma care, tailoring the information provided and frequency of contact to the parents
readiness to change their childs day-to-day asthma management. Coaching calls varied in frequency from weekly
to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after
enrollment in the study during a telephone interview.
The primary outcomes were the mean change in 1) the childs asthma control score, 2) the parents quality of life
score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected
adherence to guideline recommendations by the primary care pediatricians and included the proportion of
children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma
action plan. Cost-effectiveness of the intervention was also measured.
Discussion: Twenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with
a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is
presented.
Trial registration: ClinicalTrials.gov identifier NCT00860834.
Keywords: Asthma, Behavioral skills training, Lay coaching
Background
Asthma is the most common chronic disease of child-
hood, and in 2009 affected an estimated 7.1 million chil-
dren in the United States (9.6%) [1]. Despite advances in
preventive treatments, asthma morbidity is significant.
In 2008, children with asthma missed 10.5 million
school days, experienced 6.7 million office visits,
640,000 Emergency Department (ED) visits, 157,000
hospital admissions, and 185 died [1]. Each year, the
direct costs for asthma in the United States are more
than $8.1 billion, and in-patient hospital costs are over
$3.5 billion [2]. Reducing asthma morbidity is a national
healthcare objective [3]
In 1991, the National Asthma Education and Preven-
tion Program (NAEPP) of the National Heart, Lung and
Blood Institute (NHLBI) developed Guidelines for the
* Correspondence: jgarbutt@dom.wustl.edu
1
Department of Pediatrics, Division of Allergy and Pulmonary Medicine,
Washington University, St Louis, USA
Full list of author information is available at the end of the article
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Diagnosis and Management of Asthma,[4] with updates
in 1997,[5] 2002,[6] and 2007 [7]. Many studies have
demonstrated significant gaps between guideline recom-
mendations and actual practice. Daily treatment with
inhaled corticosteroids (ICS) or leukotriene receptor
antagonists (LTRAs) is recommended to prevent asthma
symptoms, activity limitations and minimize acute
exacerbations, [8-16] but these effective controller medi-
cations are underused [17-20]. Recent physician surveys
and pharmacy data suggest only 50-90% of eligible chil-
dren are prescribed an effective controller medication,
[20-28] and up to a third of parents do not fill their
childs prescription [20,29]. When prescriptions are
filled, adherence is poor [20,30-32]. Parents report that
not knowing how to use asthma medications effectively,
not believing them to be necessaryoften due to con-
flicting advice from friends and relatives,[33] and con-
cerns about efficacy, risks of long-term usage, cost and
social stigmatization associated with inhaler use are sig-
nificant barriers to regular use of controller medications
[18,34-37].
Short-acting beta
2
-agonists are the treatment of choice
for relieving acute symptoms,[5] and systemic corticos-
teroids may speed recovery and prevent recurrence of
exacerbations [38,39]. Early treatment with these rescue
medicationsin an acute exacerbation can reduce ED
visits, improve patient outcomes, and can be managed
effectively by the parent guided by a written Asthma
Action Plan (AAP) [40]. Yet, many families come to the
ED because of a delayed response to the childsearly
asthma signs, or failure to implement the steps detailed
on their AAP [41-43].
Morbidity is reduced and ICS use is higher in patients
who report regularly scheduled asthma visits [44,45].
The guidelines recommend 1) periodic assessments
(every 1 to 6 months) to monitor asthma control, assess
if the goals of therapy are being met, review medication
useandthechilds AAP, and adjust treatment as
needed; 2) asthma self-management education at diag-
nosis, with review and reinforcement at every opportu-
nity; 3) a partnership between the primary care provider
(PCP), the patient and their family to develop shared
treatment goals, select an appropriate treatment regi-
men, resolve asthma-related concerns, and provide sup-
port for day-to-day care. However, maintenance asthma
care delivered by PCPs is not optimal [46,47]. Only 50%
of asthmatic children report maintenance care visits
twice a year,[48] 70% report some asthma education,
and 30-50% have an AAP [1,46]. Pediatricians report
that lack of familiarity with the complex guidelines, lack
of agreement with some recommendations, low self-effi-
cacy in their ability to improve patientsself-manage-
ment behaviors, low expectation of improvements, and
the perceived associated high workload deter them from
following guideline recommendations [49-53]. In addi-
tion, logistical issues such as lack of time, educational
materials, support staff, and inadequate reimbursement
are significant barriers to guideline implementation
[46,49,50,52].
Effective interventions to improve asthma care have
been difficult to disseminate into office practice; many
physicians are unwilling or unable to attend training ses-
sions to improve their skills,[52,54-56] and most offices
do not have a nurse or health educator available to
share the work of asthma care or provide home visits
[24,57-59]. Most efforts to redesign care delivery have
been implemented in managed care settings, federally
funded or specialist clinics and have limited potential to
be translated into office-based care. Programs report
improved quality of life, reduced school and work
absences, and reduced ED visits and hospitalizations
among patients who complete the program,[58,59] but
may fail to reach up to two thirds of the target popula-
tion [57,59].
Consumer demand can change physician behavior.
Patients who ask for treatment are more likely to receive
it than those who do not make a request [60]. Direct-to-
consumer advertising has been shown to cause patients
to seek more information about a product from their
physicians and stimulate discussion about treatment
options [61]. In addition, patients with chronic illnesses
who actively participate in planning their treatment (ask
questions, review treatment options, state preferences)
are more likely to follow through with their treatment
plan, and have better health outcomes than those who
do not participate [62-66]. Participatory decision-making
also increases patient satisfaction and retention [67].
Self-management education is most effective when it
includes self management training and support and
active sustained follow-up [68]. These are some of the
key features of what we have called coachingtailored
education and support to improve asthma self-manage-
ment delivered by lay health workers [69-71]. Lay or
community health workers are from or like the commu-
nity they serve in a relevant way, and have been used
successfully to increase access to appropriate health care
services for underserved minority populations [69,72,73].
In the PARTNER study (Parents, Pediatricians and
Telephone Coaches Partner to Improve Control of
Asthma), coaching is integrated into office-based asthma
care without placing unrealistic expectations on the PCP
or their staff. The lay asthma coach encourages parents
to maintain active partnership with the pediatrician to
improve asthma control and planning for risk events
and provides tailored education about self-management
behaviors. We hypothesized that integrating this prag-
matic intervention into primary care would improve
asthma outcomes for the child and their family and also
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improve asthma care provided by their PCP. The PART-
NER Study tested this hypothesis in a randomized con-
trolled trial (RCT) comparing outcomes for practices
with access to the 12-month telephone coaching inter-
vention for their patients to those from practices who
provide usual care. Participant follow-up occurs 12 and
24-months after randomization. This paper describes
the study protocol and the coaching intervention.
Methods and design
Design and setting
The coaching intervention is being evaluated in a strati-
fied cluster randomized design, stratifying on office loca-
tion (urban or suburban) and randomizing at the
practice level, thus avoiding contamination within prac-
tices that would occur with randomization at the patient
level. Study outcomes are measured at the level of the
patient using a cohort design in which the same subjects
from each PCP are tracked throughout the study. Prac-
tices were randomly assigned to the intervention or the
control condition with all participating physicians within
thesamepracticeassignedtothesamestudygroup.
Using billing data, each practice has identified poten-
tially eligible families with a child who had received
asthma care (ICD-9 493.XX). The study team contacted
these families to invite participation, informing them of
the study group assignment of their practice prior to
obtaining their consent. Participants are followed for
two years with outcomes measured by parent interviews
and chart audit. The study was approved by Washington
University Institutional Review Board and was con-
ducted in 22 primary care pediatric practices in the
Midwest.
Participants
Practices and physicians
Practices were eligible to participate if they were com-
munity-based, affiliated with St Louis ChildrensHospi-
tal and provided primary care for children, including
asthma care for at least 40 children aged 3 to 12 years
old. At each practice, physicians were eligible to partici-
pate in the study if they spent at least 50% of their time
in general pediatrics and they were not an asthma spe-
cialist (allergist or pulmonary specialist).
Families
At each participating practice, families were eligible to
participate in the trial if their child was 3 to 12 years
old, and reported a physician diagnosis of asthma, and
1 acute exacerbation within the prior year that
required an unscheduled office visit, a course of oral
steroids, an Emergency Department (ED) visit or hos-
pitalization. Eligibility also required the parent to
report that the child was using daily controller
medications or had asthma symptoms consistent with
persistent asthma for the past 2 weeks [5]. Families
were excluded if they did not have a phone or could
not speak English, if a sibling was already a study sub-
ject, or if the child was participating in another asthma
study.
Recruitment and consent
Practices and physicians
All potentially eligible pediatricians received a written
invitation to participate and faxed back a form indicat-
ing their level of interest in study participation. The
Principal Investigator (PI) met with each PCP who indi-
cated their willingness to take part in order to explain
the requirements for study participation. One pediatri-
cian in each practice provided written consent. Although
participation by all pediatricians in the practice was
encouraged, it was not required. Each participating phy-
sician received access to the Education in Quality
Improvement in Pediatric Practice (EQIPP) asthma
module offered by the American Academy of Pediatrics,
and each practice was paid $100 to compensate for
administrative time required for study tasks.
Families
Each practice used billing data to provide a list of
potentially eligible families to the study team. These
families included those with a child between 3 and 12
years old who had received asthma care in the past year
either at the office, in the Emergency Department (ED)
or through the After Hours Call Center. Each physician
was provided an opportunity to review their list of
names to identify families they considered to be unsuita-
ble for study participation.
All potentially eligible families received an invitation
to participate in the study from their PCP and the study
team. The mailed invitation included a business reply
postcard and phone contact information to use to indi-
cate their willingness to take part. If no reply was
received within 2 weeks, a research assistant (RA) tele-
phoned to repeat the study invitation, provide informa-
tion about participation requirements and answer
questions, and complete the eligibility questionnaire.
Non-respondents received up to three phone contacts.
Consent forms were mailed to each eligible family
who was interested in study participation. One parent
(or legal guardian) per family provided written consent.
Each family was paid $20 to $25 for completion of each
of three study interviews. Parents who completed the
consent and the baseline interview were enrolled in the
study. Recruitment continued until all names provided
by the practice had been processed, or the target for
that practice was reached. The recruitment goal was an
average of 40 families/practice.
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The intervention and control conditions
The coaching intervention
The intervention comprised
Interactions with PCPs Each PCP in the intervention
group had two 45-minute face-to-face meetings with the
PIs (an asthma expert and the director of the local prac-
tice-based research network, PBRN). The goals of these
meetings were to discuss the coaching program, deter-
mine a communication plan between the coach and the
PCP, and address any issues with implementation. Inter-
mittently during the study period asthma newsletters
were circulated to all PCPs in the intervention group to
provide updates about asthma treatment and address
common issues in care identified by the coaches.
The coaching program
Program content The program is based on the trans-
theoretical model of behavior change developed by
James Prochaska [74-77]. Core constructs of the model
are the Stages of Change, a series of five categories fall-
ing along a continuum of readiness (Precontemplation,
Contemplation, Preparation, Action and Maintenance)
to change a problem behavior. Movement forward and
backward along the behavior change continuum is influ-
enced by: the Pros and Cons for the desired behavior
change; Self-efficacy or confidence in ones ability to
change; and Cognitive/Affective Processes such as gath-
ering information, being a role model, being moved
emotionally, ones self-image, and social norms; and
Behavioral Processes such as making a commitment,
substituting, rewarding, cues, and social support. The
targeted behaviors include: 1) effective use of controller
medications, 2) effective use of rescue medications, and
3) monitoring to ensure optimal control.
The coaches Four full-time lay coaches were recruited
from the local community through advertising in the
offices of participating practices and through the Uni-
versity. Three are mothers of children with asthma and
one has experience with the transtheoretical model.
Training covered asthma pathophysiology, asthma man-
agement, the transtheoretical model, building rapport,
reflective listening and communication skills. The coa-
ches were trained to stagea parent for each of the tar-
geted behaviors, and tailor the information they
provided to that assessment. Training activities included
small group discussions, demonstrations, videos, experi-
ential learning in the community, and role play. The
coaches also learned by reviewing materials to be shared
with the parents and by developing an annotated list of
useful websites. The initial training took 4 weeks, and
on-going training continued with weekly review of taped
calls and discussions about topics of interest. The coa-
ches provided support for each other.
Thecoachhelpedtheparenttoidentifywhichofthe
targeted asthma care behaviors they wanted to work on.
Triage questions and a written study protocol guided
care advice. An example of triage questions and a treat-
ment protocol is provided in Table 1. The coach
encouraged the parent to set a short-term goal and pro-
vide a confidence score (1 to 10) for goal attainment in
order to facilitate successful progress.
Program delivery Newly enrolled subjects were assigned
a coach by the coach manager and mailed a package of
PARTNER study materials for use in the coaching inter-
vention including parent educational materials, an
example of an Asthma Action Plan (AAP), and a sche-
dule of asthma education classes available in the
community.
Parents were called by their assigned coach within one
week of enrollment and invited to participate in the
coaching program. The coach provided an overview of
the program goals and content, asked the parent about
the childs asthma history, asthma treatment and treat-
ment goals, and assessed the childs level of asthma con-
trol using questions based on the NAEPP guidelines [7].
The parent was asked to accept a short-term goal to
read a booklet about asthma included in their study
materials and to provide a confidence score from 1 to
10 to indicate the likelihood this goal would be reached
in the next week. In this way, the coach introduced
study processes used during the 12-month intervention
to facilitate behavior change. The parent provided their
contact information and a phone number for two rela-
tives or friends who could be contacted if necessary.
The second coaching call occurred one week later when
the coach further described the program and the tar-
geted behaviors, determined if the parent had achieved
their short-term goal, staged the parent for each beha-
vior and helped them to identify which behavior to tar-
get for improvement. Subsequent calls occurred weekly
to monthly with the goal of addressing all three targeted
behaviors during the 12-month intervention. Coaching
calls were scheduled at times convenient for the parent
and the coach and occurred during office hours from
Monday to Friday, with evening appointments available
until 8 pm one night per week. If necessary, the parent
could leave a telephone message or send an email or
text message to their coach to reschedule a call appoint-
ment or request an additional call. The coach was avail-
able to the parent for one year, and as much as possible,
each family worked with the same coach.
The coaches were housed in an offsite call center to
allow taping of calls and ensure the research assistants
(RAs) remained blinded to group assignment during
measurement calls. A sample of recorded calls was
reviewed by the coach manager (weekly) and/or the PI
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(bi-weekly) to ensure program fidelity and provide feed-
back about management strategies. Calls were also
reviewed by the coaches (self and peer review) as a
learning resource.
The program was implemented in a flexible manner as
determined by the parentsneeds, circumstances and
preferences. If a parent was initially unwilling to receive
coaching help, the coach expressed understanding of the
competing demands on the parents time, and contacted
the parent again in a low-key, non-demanding way to
check in,repeating this until the parent decided they
wanted help with their childs asthma care. Anyone who
asked directly not to be called was removed from the
coachs call list, but could initiate calls to the coach any
time during their 12-month enrollment in the program.
The coach referred the parent to the PCP to discuss
problems, develop or modify an AAP, or for training in
useofasthmamedicationsorequipment.Thecoach
also distributed educational and other materials (such as
a symptom diary), and referred the parent to community
classes for asthma education or other community
resources as needed. If significant personal problems
that impacted asthma care were identified, the coach
encouraged the parent to seek help from their own PCP
or other advisors, and provided contact numbers for
community resources. A resource manual was developed
to assist the coach with these referrals and the PIs were
available for consultation as needed.
The primary mechanism for communication between
the coach and the PCP was through the parent. In addi-
tion, with the parents permission, the coach provided a
one-page faxed summary after 6-months and at the end
of the program describing the childs asthma care and
history of asthma control assessed during coaching calls.
If the coach had particular concerns or was aware that
the parent planned to return to their PCP for an asthma
care visit, they sent a concernsfax detailing any cur-
rent problems and relevant information for the PCP,
and the PCP was invited to notify the coach if there was
a particular problem they wanted the coach to address.
The coach used forms developed for the study to guide
their interaction with the parent, and record their
activities.
The control condition At the beginning of the study, all
PCPs (intervention and control groups) received a flow
chart for recommended administration of albuterol for
worsening symptoms and information to help them
overcome known barriers to additional maintenance
care visits such as scheduling and billing difficulties
[78,79]. They were also provided access to the EQIPP
asthma module.
Measurements All patient outcomes were measured by
telephone interview of the parent or child, or by chart
audit.
Physician measurements All PCPs who signed the con-
sent completed a brief, self-administered baseline
Table 1 Effective use of prescription controller medication(s)
STAGING QUESTIONS ANSWERS STAGE
Has your child been prescribed a controller medication (e.g.,
Pulmicort, Flovent or Singulair)? If yes, how often is it
supposed to be given?
No
Yes
NA
Continue questions
Tell me about yesterday.
What medication(s) did you give?
What time(s)?
How about the day before that?
Go back as far as you need to get a sense of
whether the meds are being given correctly
or not
Is the controller medication(s) used every day as directed?
How often are doses missed? How many missed doses in the
last week?
If has been doing it correctly for
more than 6 months
Maintenance
(I STILL AM)
Possible Questions to help answer above question
Do you have controller medications at home now?
If no, why?
Have you ever tried to use them every day? How did your
child respond?
Why did you stop?
Do you think that controller medications help the asthma?
If doing it correctly at least for
the last week
Action
(I AM)
If doing it some of the time
and intending to do better
Preparation
(I WILL)
If not doing it but thinking
about how to do it
Contemplation
(I MAY)
If not doing it because bogged
down
Precontemplation Believer
(I CANT)
If not doing it because dont
believe in giving children
regular meds
Precontemplation Nonbeliever
(I WONT)
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questionnaire concerning their own and their practice
demographics and features of asthma care provided for
their patients. At the 24-month follow-up, all participat-
ing PCPs complete a self-administered questionnaire
detailing the asthma care they provide, how they assess
asthma control, and their confidence about providing
asthma care. PCPs who participate in the intervention
group provide feedback about the coaching program.
Participant measurements
Interviews Interviews are conducted at baseline and 12
months to assess the impact of the intervention and at
24 months to assess if changes were sustained. Each
interview was conducted by phone by a trained research
assistant (RA) blinded to study group assignment and
takes 20-30 minutes to complete. The baseline interview
was completed after the signed parental consent was
received or, with verbal consent, during the initial
recruitment call. The 12-month and 24-month inter-
views were conducted on the appropriate anniversary of
enrollment into the study using (call windows of 12 to
18monthsand24to27months).Iftheparentcould
not be reached (answering machine, busy signal, no
answer), multiple calls were made at different times of
the day, on different days. Alternative numbers were
called to allow other contacts to notify the parent. If the
number was disconnected, it was called the following
day and then weekly during the call window to see if it
had been reconnected.
Content For each interview, questions focused on
asthma management, asthma outcomes, interactions
with the PCP, and costs. Demographic information was
collected at baseline.
The parent reported all medications used for asthma
in the past week and whether or not they had an up-to-
date asthma action plan (AAP). The child (if 5years
old) completed the Asthma Control Questionnaire
(ACQ) (with permission) [80-83] to indicate their level
of asthma control. The ACQ was also completed by the
parent. Disease-specific quality of life (QOL) was mea-
sured for the parent using the validated, interviewer-
administered 13-item Pediatric Asthma Caregivers
Quality of Life Questionnaire (PACQLQ) (with permis-
sion) [84]. Additional questions were asked about the
frequency of asthma symptoms in the past 2 weeks and
the number of days missed from school and work in the
past year. Asthma risk was measured as reported urgent
care episodes (events that required treatment with oral
steroids or aerosolized bronchodilators in ED or office,
or hospitalization for each 12-month measurement per-
iod). If the child received multiple types of urgent care
on the same day, the most extensive level of treatment
received was counted (hospitalization > ED > office
visit). Using data from an entire calendar year avoids
bias due to seasonal changes in the disease. Three
questions from the Medical Outcomes Study [85] were
use to assess the PCPs participatory style and an instru-
ment developed by Wu and colleagues [86] was used to
assess parent perceptions of asthma including their
expectations about their childs asthma symptoms and
functioning, concerns about controller medications, and
competing family priorities. Parents also reported their
costs for asthma medications and visits, and provided
income information.
Chart audits Audits of PCP charts assess office visits
for asthma care over 3 time periods: the 12 months
prior to enrollment and the two 12 month periods fol-
lowing enrollment. Asthma visits that occurred in each
12-month measurement period are categorized using a
non-overlapping classification scheme.
PrimaryandsecondaryoutcomesThe primary out-
comes are a reduction in asthma impairment measured
as improvement in asthma control and in asthma-
related quality of life, and a reduction in asthma risk
measured as a decrease in urgent care events. Secondary
outcomes reflect changes in physician behavior, namely
increased adherence to guideline-recommended mainte-
nance care activities measured as the proportion of
patients who report daily use of controller medications,
an AAP and regular maintenance care visits. Aggregates
of patient-level data are used to estimate physician
behavior, recognizing that external factors such as par-
ent behaviors and logistical issues may influence these
measures.
Analytic plan All main data analyses adhere to the
intention-to-treat principle, quantifing the intervention
effect both at the level of the cluster (practice), and at
the level of the individual patient. In addition, a multile-
vel modeling strategy is used to explore the possible
interaction of cluster and individual level covariates in
modifying the intervention effect. A similar approach is
taken for primary and secondary outcomes. Confound-
ing factors are controlled for both in the study design
(by stratification) and data analyses (regression model-
ing). All inferential analyses use a 2-tailed alpha of .05
to determine statistical significance. The cost-effective-
ness and cost-benefit of the coaching program is
assessed from societysviewpointandfromthepointof
view of an insurance company or large self-insured
employer with sensitivity analysis to estimate the robust-
ness of the results.
Sample size determination The sample size and power
determination considered the three primary outcomes:
thechangeinACQscoresfrombaselineto12-months,
the change in asthma-related QOL for the parent from
baseline to 12-months measured with the PACQLQ,
[84] and the probability of having 2 urgent care events
within the first 12-months of the study. The Bonferroni
method was used to allocate the type-I error rate equally
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among these three outcomes and maintain the overall
study type-I error at 5%. Data from two prior studies
were used to estimate the sample size [16,70].
For asthma control, assuming the between-group dif-
ference in the change between the baseline and 12
month ACQ scores to be 0.5 [83] and the standard
deviation (SD) of the change in ACQ score of 0.90 in
each group, then 11 or 12 practices in each arm with an
average of 40 subjects/practice provides power of 97%
and 99% respectively. For the parentsquality of life,
assuming a 12-month change in PACQLQ scores of
0.26 (SD 1.18) in the control group and 0.66 (SD 1.18)
in the intervention group, and the ICC of change in
scores of 0.021, then 11 or 12 practices in each arm
with an average of 40 subjects/practice provides power
of 86% and 90% respectively. For urgent care events,
assuming an interclass correlation coefficient (ICC) of
0.034, and a probability of urgent care events in the
control group of 30%, and 16% in the intervention
group, then 11 or 12 practices in each arm with an aver-
age of 40 subjects/practice provides power of 81% and
85% respectively.
We originally elected to have 12 practices in each arm,
with an average of 40 subjects/PCP to ensure sufficient
power for uncertainty in ICC estimates. However, due
to pragmatic concerns, the Data Safety Monitoring
Board(DSMB)agreedwithusingonly11practicesin
each arm given that one solo PCP who was randomized
to the intervention arm had a protracted illness that
precluded our ability to implement the intervention
within the study timeline, and another solo practice allo-
cated to the control group was unable to provide patient
lists. In addition, our recruitment target of 40 families/
practice was met.
Chart audits Audits of PCP charts assess office visits
for asthma care over 3 time periods: the 12 months
prior to enrollment and the two 12 month periods fol-
lowing enrollment. Asthma visits that occurred in each
12-month measurement period are categorized using a
non-overlapping classification scheme.
PrimaryandsecondaryoutcomesThe primary out-
comes are a reduction in asthma impairment measured
as improvement in asthma control and in asthma-
related quality of life, and a reduction in asthma risk
measured as a decrease in urgent care events. Secondary
outcomes reflect changes in physician behavior, namely
increased adherence to guideline-recommended mainte-
nance care activities measured as the proportion of
patients who report daily use of controller medications,
an AAP and regular maintenance care visits. Aggregates
of patient-level data are used to estimate physician
behavior, recognizing that external factors such as par-
ent behaviors and logistical issues may influence these
measures.
Analytic plan All main data analyses adhere to the
intention-to-treat principle, quantifing the intervention
effect both at the level of the cluster (practice), and at
the level of the individual patient. In addition, a multile-
vel modeling strategy is used to explore the possible
interaction of cluster and individual level covariates in
modifying the intervention effect. A similar approach is
taken for primary and secondary outcomes. Confound-
ing factors are controlled for both in the study design
(by stratification) and data analyses (regression model-
ing). All inferential analyses use a 2-tailed alpha of .05
to determine statistical significance. The cost-effective-
ness and cost-benefit of the coaching program is
assessed from societysviewpointandfromthepointof
view of an insurance company or large self-insured
employer with sensitivity analysis to estimate the robust-
ness of the results.
Sample size determination The sample size and power
determination considered the three primary outcomes:
thechangeinACQscoresfrombaselineto12-months,
the change in asthma-related QOL for the parent from
baseline to 12-months measured with the PACQLQ,
[84] and the probability of having 2 urgent care events
within the first 12-months of the study. The Bonferroni
method was used to allocate the type-I error rate equally
among these three outcomes and maintain the overall
study type-I error at 5%. Data from two prior studies
were used to estimate the sample size [16,70].
For asthma control, assuming the between-group dif-
ference in the change between the baseline and 12
month ACQ scores to be 0.5 [83] and the standard
deviation (SD) of the change in ACQ score of 0.90 in
each group, then 11 or 12 practices in each arm with an
average of 40 subjects/practice provides power of 97%
and 99% respectively. For the parentsquality of life,
assuming a 12-month change in PACQLQ scores of
0.26 (SD 1.18) in the control group and 0.66 (SD 1.18)
in the intervention group, and the ICC of change in
scores of 0.021, then 11 or 12 practices in each arm
with an average of 40 subjects/practice provides power
of 86% and 90% respectively. For urgent care events,
assuming an interclass correlation coefficient (ICC) of
0.034, and a probability of urgent care events in the
control group of 30%, and 16% in the intervention
group, then 11 or 12 practices in each arm with an aver-
age of 40 subjects/practice provides power of 81% and
85% respectively.
We originally elected to have 12 practices in each arm,
with an average of 40 subjects/PCP to ensure sufficient
power for uncertainty in ICC estimates. However, due
to pragmatic concerns, the Data Safety Monitoring
Board(DSMB)agreedwithusingonly11practicesin
each arm given that one solo PCP who was randomized
to the intervention arm had a protracted illness that
Garbutt et al.BMC Pediatrics 2012, 12:42
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Page 7 of 11
precluded our ability to implement the intervention
within the study timeline, and another solo practice allo-
cated to the control group was unable to provide patient
lists. In addition, our recruitment target of 40 families/
practice was met.
Discussion
The PARTNER study is evaluating a business model for
dissemination of asthma coaching into office practice.
Subject recruitment is completed and 463 families have
been randomized to the coaching intervention. During
implementation of the PARTNER intervention the
coaching process and quality monitoring procedures
have been refined, and a manual and training program
developed. Comparison of the processes in PARTNER
with a previous telephone asthma coaching intervention,
in which the coaches were nurses and worked part-time
[70], has been instructive. Based on our experience in
these two studies, we would propose that a coaching
intervention include the following features:
The coach should have shared experiences with the
parents being coached. In particular, the shared
experience of caring for a child with asthma is help-
ful in building the coaching relationship and estab-
lishing the credibility of the coaches. Parents seem
to be more willing to engage with a peer coach than
a nurse coach.
The coach should be a full-time position. Each
coach works 40 hours/week including one evening
until 8 pm, with no weekend calls and works the
same hours each week. Defined off time is impor-
tant. Flexibility of work hours has made the position
available to mothers of young children. Compared to
a part-time model, full time employment of the
coach provides easy access for training and support,
and more opportunity for the coach to book and
complete parent calls.
Structured work hours, recurring appointments
and a protocol to guide outreach efforts for parents
who had missed an appointment facilitates successful
contacts and use of additional communication chan-
nels (email, text messages) helps to schedule calls.
Some parents are more willing to talk to the coach
using cell phones rather than a landline, likely
because they can verify the identity of the caller
more easily via callback or text messaging to the
coachs cellphone.
Increasing the intensity of the intervention by
increasing the number of calls during the 12-month
intervention increases parentswillingness to actively
participate in the coaching intervention. To date, the
mean number of calls/family/year is 18.24 compared
to the previous study where only 15% of participants
had 9 calls.
Ongoing training is essential: Coaches need to be
knowledgeable about asthma, staging, and behavior
change techniques, and have strong communication
skills including reflective listening, empathy and tele-
phone interviewing. The initial training included
these skills, but ongoing monitoring and training is
needed to maintain the quality of the intervention.
Regular review of coaching calls (self-review, peer-
review and review by managers) using a structured
review tool together with written and oral feedback
provides an essential learning experience for the coa-
ches and the investigators.
Locatingthecoachesinthesamephysicalspace
fosters a collegial team environment and provides
opportunity for social support and immediate feed-
back about a difficult call.
Thecoachinginterventionmayimproveasthmacon-
trol and disease-related quality of life and reduce urgent
care events for asthma care. We hope that sharing the
protocol and lessons learned will be helpful to other
investigators interested in using a coaching intervention.
Abbreviations
AAP: Asthma action plan; ACQ: Asthma control questionnaire; ED:
Emergency department; EQIPP: Education in quality improvement in
pediatric practice; DSMB: Data safety monitoring board; ICC: Intraclass
correlation coefficient; ICS: Inhaled corticosteroids; LTRAs: Leukotriene
receptor atagonists; NAEPP: National asthma education and prevention
program; NHLBI: National heart lung: and blood institute; PACQLQ: Pediatric
asthma caregivers quality of life questionnaire; PARTNER: Parents
pediatricians and telephone coaches partner to improve control of asthma;
PCP: Primary care provider; PBRN: Practice-based research network; PI:
Principal investigator; QOL: Quality of life; RA: Research assistant; RCT:
Randomized controlled trial.
Acknowledgements
This work was funded by a grant from the National Heart, Lung and Blood
Institute (HL072919) at the National Institute of Health.
We thank the families and pediatricians and their staff for participating in
this study. We thank the PARTNER project team for all their hard work on
this project: Sherry Dodd, Vanetta Worthy, Christina Banister, Allie Grither and
Robbin Walker for subject recruitment and measurement; Shannon Rook,
Meghan Winter, Charis Johnson and Lisa Swerczek for coaching. We also
thank Kathy Manrdrell for her help with the manuscript.
Author details
1
Department of Pediatrics, Division of Allergy and Pulmonary Medicine,
Washington University, St Louis, USA.
2
Department of Medicine, Washington
University, St Louis, USA.
3
Winds of Change at Crosswinds, 154 Hatchville
Road, East Falmouth, MA 02536, USA.
4
Department of Surgery, Washington
University, St Louis, USA.
5
General Medical Sciences, Washington University
School of Medicine, Campus Box 8005, 660S. Euclid Ave., St. Louis, MO
63110, USA.
Authorscontributions
JMG and RCS conceived the study and participated in its design and
coordination. JMG drafted the manuscript. GH designed the coaching
intervention and trained the coaches. YY participated in the design of the
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study, did the sample size calculation, generated the random allocation
sequence and assigned participants to interventions. All authors read and
approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 15 February 2012 Accepted: 2 April 2012
Published: 2 April 2012
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doi:10.1186/1471-2431-12-42
Cite this article as: Garbutt et al.: Partner randomized controlled trial:
study protocol and coaching intervention. BMC Pediatrics 2012 12:42.
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Garbutt et al.BMC Pediatrics 2012, 12:42
http://www.biomedcentral.com/1471-2431/12/42
Page 11 of 11
    • "SÍNTESE E AVALIAÇÃO DOS ESTUDOS Garbutt et al. (2012) "
    [Show abstract] [Hide abstract] ABSTRACT: RESUMO Objetivos: Tendo em vista que a educação em asma é importante para aumentar a adesão ao tratamento, e assim, o controle da doença, o objetivo desta revisão foi identificar os principais estudos sobre intervenção de educação em asma. Métodos: Foi realizada uma revisão da literatura para identificar os principais estudos que aplicaram medidas pré e pós-intervenção de educação em asma. Aplicou-se a lógica de pesquisa nas bases de dados PubMed, Lilacs, Scopus, ScienceDirect e Cochrane. Os artigos foram incluídos mediante descrição completa da aplicabilidade das medidas, suas respostas e as conclusões para o desfecho em programas de educação em asma para crianças e adolescentes. Resultados: Doze pesquisas foram incluídas na revisão. Das intervenções encontradas, quatro foram consideradas as mais aconselháveis por apresentarem resultados satisfatórios em relação à melhor compreensão dos diversos aspectos da asma. Conclusões: A educação em asma é fundamental tanto para a adesão do cuidado domiciliar quanto para o autocontrole eficaz da doença. Por essa razão recomenda-se fortemente que, para que sejam alcançados os objetivos de autocontrole da doença e melhor qualidade de vida possível, o processo educativo deva ser individualizado, contínuo, progressivo, dinâmico e sequencial. O programa de controle da asma precisa ser não apenas pontualmente efetivo, mas também regular, para ter maior impacto nos indicadores de saúde e qualidade de vida.
    Full-text · Article · Aug 2014
    • "Tabela 1. Principais características dos estudos que aplicaram medidas pré e pós-intervenção de educação em asma em crianças e adolescentes. Garbutt et al. (2012) 18 descrevem o protocolo para um estudo clínico randomizado que teve por objetivo avaliar um programa de treinamento por telefone, com duração de 12 meses, cujo público alvo do experimento foram crianças com idade de três a 12 anos que apresentavam asma persistente. A finalidade desse treinamento foi dar suporte à autogestão de cuidados primários da asma, com a adesão ao tratamento, proporcionando melhor qualidade de vida por meio de um melhor controle da asma, reduzindo os eventos de atendimento de urgência. "
    [Show abstract] [Hide abstract] ABSTRACT: AIMS: Asthma education is one of the outcomes that should be applied to self-management, in order to increase adherence to treatment, thus increasing the control of the disease. The objective of this review was to identify the main interventional studies for asthma education. METHODS: A review was performed to identify the major studies that have applied measures pre and post intervention for asthma education. We applied the logic of searching the databases: PubMed, Lilacs, Scopus, ScienceDirect, and Cochrane. Articles were included after complete description of the applicability of the measures, their answers and conclusions for the outcome in asthma education programs for children and adolescents. RESULTS: Twelve studies were included in the review. Among the interventions found, four were considered the most advisable for presenting satisfactory results in an enhanced understanding of the various aspects of asthma. CONCLUSIONS: Asthma education is essential both for the compliance with home care as for effective self-control of the disease. Therefore, it is strongly recommended that in order to achieve the goals of the best possible quality of life and self-control of the disease, the educational process should be individualized, continuous, progressive, dynamic and sequential. The program of asthma control needs to be not only timely, but also regular, to have a greater impact on health indicators and quality of life.
    Full-text · Article · Jan 2014
    • "Design of studies in this context is relatively straightforward with specific, quantifiable and objective end points (for example, reduction in weight, blood pressure or substance misuse). In 2011 alone there were 197 papers cited within PubMed examining the application of motivational interviewing in supporting behaviour change in, for example, families of asthma sufferers (Garbutt, Highstein, Yan, & Strunk, 2012) and obesity management (Pearson, Irwin, Morrow, & Hall, 2012). In support of this work interviewing skill effectiveness measures for clinicians have been developed (Torres et al., 2012 ) to allow consistent practice and comparison within research studies. "
    Full-text · Chapter · Jan 2014 · Scientia Medica
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