Perspectives in Implementing a Primary

Care–Based Intervention to Reduce

Alcohol Misuse
Evette J. Ludman, PhD,1 Susan J. Curry, PhD2

In 2013, the U.S. Preventive Services Task Force (USPSTF) recommended screening followed by
brief behavioral counseling to reduce alcohol misuse. Our study, Options Regarding Consumption
of Alcohol (ORCA), was one of the studies included in an evidence review that comprised 23 RCTs.
ORCA was designed to test whether a primary care–based intervention would reduce alcohol misuse
among patients who screened positive for risky or hazardous drinking. Data collection occurred
between 1995 and 1999; data analysis was conducted in 2000–2002. Study design and implementa-
tion built from a behavioral counseling research paradigm with four components: (1) population-
based screening; (2) centralized delivery of intervention components; (3) involvement of primary
care practitioners to motivate and reinforce behavior change; and (4) personalization of intervention
components. In this paper, we assess the study features using the Pragmatic–Explanatory
Continuum Indicator Summary Model domains. As a randomized trial, the study included some
explanatory features (e.g., standardized follow-up surveys administered by study personnel);
however, several aspects of the study were highly pragmatic. Practicable recruitment and training
of providers, embedding population-based screening in pre-visit surveys, and keeping the delivery of
the primary care intervention components consistent with the tempo and competing priorities of
practice are three key features that contributed to the study’s success and relevance to the USPSTF.
(Am J Prev Med 2015;49(3S2):S194–S199) & 2015 American Journal of Preventive Medicine. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Introduction more drinks on a single occasion) or of driving after

consuming three or more alcoholic beverages.5,6

T
he selection of alcohol misuse as a prevention
The majority of individuals across sociodemographic
priority by the U.S. Preventive Services Task
groups make at least one healthcare visit per year.7
Force (USPSTF) reflects the robust body of
Thus, integrating screening and intervention for risky
evidence showing that alcohol misuse contributes sub-
or hazardous drinking into the healthcare setting
stantially to premature morbidity and mortality.1 Neg-
enables broad reach for prevention strategies that could
ative health, social, and economic consequences of
disrupt progression to an alcohol use disorder. Discus-
alcohol misuse occur across a range of behaviors, from
sing drinking patterns in the context of a primary care
risky or hazardous drinking to severe alcohol use
visit can focus on overall health as a motivation to
disorder, a chronic condition resulting from loss of
change drinking patterns, and routine medical care can
control over alcohol use.2,3 Over the life span, heavy
provide ongoing support and encouragement for
drinkers have mortality ratios of two or more in
behavior change. In addition, the prestige of health
comparison with moderate drinkers and abstainers.4
professionals can enhance the social influence of their
The risk of death, injury, and negative social consequen-
advice.
ces increases even through occasionally engaging in risky
Following an extensive review of evidence regarding
drinking patterns of binge drinking (consuming five or
screening and intervention for alcohol use, the USPSTF
recommended that “clinicians screen adults aged 18
From the 1Group Health Research Institute, Group Health Cooperative, years or older for alcohol misuse and provide persons
Seattle, Washington; and 2College of Public Health, University of Iowa,
Iowa City, Iowa engaged in risky or hazardous drinking with brief
Address correspondence to: Evette Ludman, PhD, Group Health behavioral counseling interventions to reduce alcohol
Research Institute, 1730 Minor Avenue, Suite 1600, Seattle WA 98101- misuse. (B recommendation).”8 The evidence review
1448. E-mail: ludman.e@ghc.org.
0749-3797/$36.00 included 23 RCTs, of which 11 were conducted in the
http://dx.doi.org/10.1016/j.amepre.2015.05.016 U.S. All but four studies were published prior to 2003.

S194 Am J Prev Med 2015;49(3S2):S194–S199 & 2015 American Journal of Preventive Medicine  Published by Elsevier Inc. This
is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
 Ludman and Curry / Am J Prev Med 2015;49(3S2):S194–S199
This paper describes the development and implemen-
tation of one of the primary care–based studies that
informed the USPSTF recommendation. Options
Regarding Consumption of Alcohol (ORCA) was con-
ducted in 23 primary care practices at Group Health
Cooperative, a nonprofit, consumer-governed HMO in
western Washington in the mid-to-late 1990s. Data
collection occurred between 1995 and 1999; data analysis
was conducted in 2000–2002. Results from the study
have been published previously and the main outcome
paper was published in 2003.9,10 The intervention
achieved significant reductions in risky drinking practi-
ces that included chronic drinking, binge drinking, and
drinking and driving.
Here, we describe the intervention research paradigm
that informed the ORCA study and the strategies used to
recruit and retain primary care physician practices. Note
that the intervention was delivered using formats appro-
priate to the primary care practice setting in the mid-
1990s. Since that time, advances in health information
technology and changes in the organization of primary
care practice provide opportunities to modify the deliv-
ery of the intervention. However, the active ingredients of
behavioral counseling interventions (e.g., motivational
feedback, self-monitoring, problem solving, social sup-
port) remain state of the art.
The primary focus of this paper is on the recruitment
and implementation of a primary care–based behavioral
counseling intervention. We use the Pragmatic–Explan-
atory Continuum Indicator Summary (PRECIS) model11
to evaluate the components of the study design, imple-
mentation, and analysis on a continuum of pragmatic to
explanatory research and conclude with a few key
“lessons learned” that could inform future primary care
behavioral counseling research studies.
Intervention Research Paradigm
The considerable appeal of the primary care setting for
addressing alcohol misuse as part of routine preventive
care is tempered by challenges related to lack of time,
competing priorities, and a lack of infrastructure and
staffing for delivery or referral to behavioral counseling.
Trends in healthcare toward organizing for chronic
disease management rather than acute care, endorsement
of evidence-based guidelines by professional organiza-
tions, increasing investment in clinical information sys-
tems and electronic medical records, and prioritization of
quality of care and patient satisfaction can help address
these challenges. The Chronic Care Model, which has
been widely adopted as a standard for organization of
healthcare delivery, is an overarching framework that
informed the development of the ORCA study’s
September 2015
S195
12,13
protocol. The model highlights the importance of
clinical information systems (e.g., electronic health
records and patient registries); decision support (e.g.,
evidence-based practice guidelines); delivery system
design (e.g., specified roles for all practice personnel);
and self-management support (e.g., behavioral counseling
interventions) that may be supported by community
resources.
At the time this study was being designed and
implemented, the research team had been involved in
several primary care–based behavioral counseling stud-
ies.14–20 Although the behavioral targets and study
protocols varied, all of the studies benefited from the
Chronic Care Model as a guiding framework as well as
from a foundational commitment to “get practice into
research.” We operationalized this commitment by
including frontline medical staff as full partners in our
research, selecting research questions that would inform
innovation and evidence-based guidelines, and using
research designs that were compatible with emerging
care models. Over time, these goals coalesced into a
behavioral counseling research paradigm with four main
components:
1. population-based identification of the target
population;
2. centralized delivery of intervention components
through written materials and trained behavioral
interventionists;
3. involvement of the primary care practice team as
adjunctive motivators and reinforcers; and
4. personalization of intervention components through
modalities including computerized feedback and out-
reach telephone counseling.
Implementing Options Regarding
Consumption of Alcohol
The ORCA study was funded by the National Institute on
Alcohol Abuse and Alcoholism with the primary aim of
conducting a randomized trial of a primary care–based
at-risk drinker intervention compared with usual care.
Secondary aims were to describe the alcohol use patterns
of patients making routine healthcare visits and to
evaluate treatment mediators and moderators. Table 1
summarizes the main components of the ORCA study
with reference to the ten dimensions outlined in the
PRECIS model.
The ORCA study had components that were prag-
matic, some that were explanatory, and many that fit
squarely at the nexus of each continuum. Components
that were particularly pragmatic involved the selection,
training, and brief intervention delivery by the primary
S196
Table 1. Summary of ORCA Trial and PRECIS Model Domains
PRECIS domain
Participants
Participant eligibility criteria
Interventions and expertise
Experimental intervention
flexibility
Experimental intervention
practitioner expertise
Ludman and Curry / Am J Prev Med 2015;49(3S2):S194–S199
Assessment of domain for ORCA trial
The trial enrolled primary care patients with advance appointments who completed a telephone
interview and scored 15 or below on the Alcohol Use Disorders Identification Test (AUDIT)a and
had at least one of the following drinking patterns: (1) consuming an average of two or more
alcoholic drinks per day in the past month (chronic drinking); (2) two or more episodes of binge
drinking (consuming five or more drinks on a single occasion in the past month); (3) one or more
episodes of driving after consuming three or more drinks in the past month. Providers reviewed
lists of scheduled patients and ruled ineligible those who were known to be pregnant, terminally
ill, cognitively impaired, or to have an alcohol use disorder (AUD).
Explanatory/Pragmatic: The study screened all patients in advance of non-urgent
appointments and provided the intervention to those with the targeted self-reported risky
drinking patterns, rather than all primary care patients who drink alcohol. However, patients
were not required to make any special office visits for alcohol counseling.
Provider-delivered intervention
A flow chart to guide a 1–5-minute motivational discussion was clipped to the front of a
patient’s chart on the day of their visit. The flow chart followed the “ask, advise, assist” format
and included a simple algorithm based on the patient’s current intention to change their
alcohol consumption to guide the provider’s discussion. Providers reconfirmed the patient’s
self-reported drinking patterns, provided supportive advice about potential risks associated
with those drinking patterns, asked the patient if they had thought about changing their
drinking habits, and gave a motivational message that acknowledged the patient’s current
intentions.
Pragmatic: Providers were given a flow chart outlining steps to take in a discussion, but the
specific discussion was up to the provider.
Self-management support booklet
Providers gave patients a booklet, Drinking Alcohol: A Guide for Evaluating and Changing
Drinking Patterns.b The booklet included safe drinking limits on the inside cover and had five
sections “Take Stock of Your Drinking,” “Decide to Change Your Drinking Habits,” “Set Limits,”
“Stay Within Limits,” and “Keep a Healthy Balance.”
Pragmatic: A standard booklet was given to all patients.
Printed Personalized Feedback
Providers handed the patient a sheet with personalized feedback that (1) provided normative
information about the prevalence of the patient’s reported drinking patterns and associated
risks; (2) highlighted the patient’s reported intrinsic motivators for changing drinking patterns
and compared them to others who have successfully changed; and (3) highlighted the “cons” of
at-risk drinking patterns that they endorsed on the screening survey.
Explanatory: Patients’ survey answers and theory-based computerized algorithms determined
individualized printed feedback.
Telephone Counseling
A telephone counselor made three outreach calls approximately 1–2 weeks after the patient’s
clinic appointment, 4 weeks after the first call, and 4 weeks after the second call to encourage
the patient to use the self-management support booklet and reinforced the motivational
messages they received in the personalized feedback.
Explanatory/Pragmatic: The telephone counselor was provided a manual that included goal-
driven protocols for each call that depended on the patient’s readiness to change. However, the
format or the approximately 15-minute calls was open-ended and flexible.
Provider-delivered intervention
All providers delivering primary care in each practice group were involved. Providers were trained
individually via academic detailing in which a study staff member got on each provider’s office visit
schedule for a brief education and demonstration session lasting 15 minutes to an hour.
(continued on next page)
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 Ludman and Curry / Am J Prev Med 2015;49(3S2):S194–S199
Table 1. Summary of ORCA Trial and PRECIS Model Domains (continued)
PRECIS domain
Comparison intervention
Comparison intervention
practitioner expertise
Follow-up and outcomes
Follow-up intensity
Primary trial outcome
Compliance/adherence
Participant compliance with
“prescribed” intervention
Practitioner adherence to study
protocol
Analysis
Analysis of the primary outcome
a
Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro, MG. AUDIT: The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care.
Second Edition. Geneva: WHO; 2001.
b
Spivak K, Sanchez-Craig M, Davila R. Assisting problem drinkers to change on their own: Effect of specific and non-specific advice. Addiction 1994;89
(9):1135-1142.
ORCA, Options Regarding Consumption of Alcohol; PRECIS, Pragmatic-Explanatory Continuum Indicator Summary.
September 2015
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Assessment of domain for ORCA trial
Pragmatic: All primary care providers were involved with minimal training.
Telephone Counseling
The telephone counselor was a graduate-level clinical psychology student with prior training in
behavioral management of alcohol misuse. The counselor received training over a series of
study team meetings and received ongoing supervision.
Explanatory: The telephone counselor had a background in behavior change counseling and
received additional training and supervision.
The intervention was compared to usual care. For patients in the usual care group, their
medical charts were not flagged and providers were given no materials to provide to patients.
Pragmatic: The comparison intervention was usual practice.
The same primary care providers delivered care to both intervention and usual care patients.
Pragmatic: All primary care providers were involved.
Two follow-up telephone surveys were conducted at 3 and 12 months post-randomization by
interviewers masked to the patient’s intervention status.
Explanatory: Study personnel conducted the follow-up surveys for both intervention and control
patients.
The primary outcomes were self-reported prevalence of two at-risk drinking practices and self-
reported weekly alcohol consumption.
Explanatory/Pragmatic: Although the primary trial outcomes were the outcomes that the
intervention was expected to have direct effect on (explanatory), the outcome status did not
require research team adjudication and relied on self-report (pragmatic).
This was an intent-to-treat trial, and not all participants received the “full dose” of intervention
components. Receipt of the intervention was tracked for descriptive purposes. The telephone coun-
selor kept records of each call’s duration and content, and patients were asked about whether they
recalled receiving telephone counseling and used the self-management support booklet at follow-up.
Pragmatic: The telephone counselor made repeated attempts to contact patients but there
were no other adherence-boosting measures.
Primary care providers
Delivery of the intervention to patients was traced through completion of a checkbox on the flow
chart attached to each patient’s chart. If providers did not deliver the intervention, they were
asked to note the reason on the flow chart. Study personnel retrieved the flow charts daily.
Pragmatic: Provider adherence was measured mostly for descriptive purposes although
providers knew the flow charts would be collected and monitored.
Telephone counselor
The telephone counselor completed call summary sheets after every call. Calls were discussed
during supervision with study investigators, focusing mostly on patients who were difficult to
reach or difficult to engage.
Explanatory/ Pragmatic: Telephone calls were not monitored or taped; however, call summary sheets
were reviewed and coaching was given for the purpose of improving the counselor’s expertise.
An intention-to-treat analysis was conducted including all participants regardless of dose of
intervention received and patient or provider compliance with intervention protocols.
Pragmatic: All randomized patients were included in the primary analysis. No patients were
excluded post randomization.
S198 Ludman and Curry / Am J Prev Med 2015;49(3S2):S194–S199
care providers. Rather than selected providers, all pro-
viders at the study clinics received minimal training via
educational outreach visits or academic detailing.21 This
involves the trainer arranging a brief visit to the
provider’s office. Training included demonstrations and
role-plays. The intervention was delivered during patient
encounters scheduled for other concerns. Providers
received a chart cue and conducted a brief flexible
discussion based on the familiar “Ask, Advise, Assist”
format. Their adherence was not strictly monitored. The
comparison intervention was usual care delivered by the
same providers. Another pragmatic element was the
intent-to-treat analysis; all randomized patients were
included in the trial’s primary analysis regardless of
whether or how much of the intervention they received.
Characterized as more explanatory were components
delivered to participants in the intervention condition by
the telephone counselor. The telephone counselor had
some prior expertise in behavioral alcohol misuse inter-
ventions and received additional training, support, and
monitoring from study personnel over the course of the
trial. Study personnel were also used to conduct baseline
and follow-up telephone surveys. Baseline survey
responses were used to screen patients for eligibility
and produce printed personalized feedback to interven-
tion patients. The study screened all patients who had
advance appointments and enrolled only those with the
targeted self-reported risky drinking patterns rather than
all primary care patients. More pragmatically, patients
were not required to make any special office visits for
alcohol counseling. Follow-up surveys conducted outside
of regular clinical care at 3 and 12 months assessed the
primary trial outcomes.
It is important to note that even some of these
explanatory/non-pragmatic aspects of the study protocol
could be more pragmatic in practice. The increased use of
pre-visit assessments and electronic health records would
make screening and flagging of patients and even the
creation of a personalized feedback document possible
without research infrastructure. In addition, as primary
care teams evolve to include allied professionals with
behavioral counseling expertise, follow-up phone con-
tacts (currently used more for chronic disease manage-
ment) could be easily integrated with routine practice.
We identify three key components of the study’s
success and relevance to the USPSTF recommendations
that can inform the design of future studies of primary
care–based counseling. First, recruiting and training of
providers must be practicable. In this study, all provider
contact occurred in the course of their regularly sched-
uled workday and was personalized based on individual
provider’s knowledge, attitudes, and confidence. We
recruited providers during their regularly scheduled staff
meetings. For training, we met providers in their offices
at their preferred times including before, during, or after
clinic hours and adapted the training for the time allotted
by each. Providers expressed strong feelings and varied
widely in their beliefs about safe drinking limits and we
personalized the training to respond respectfully to their
attitudes and beliefs. For example, some providers
thought the nationally recommended weekly limits were
actually much higher and some thought they were lower.
In either case, the trainer nonjudgmentally presented the
correct limits for men and women.
A second key aspect of the intervention was embed-
ding population-based screening and cohort identifica-
tion in pre-visit surveys. Providers must be able to know
immediately whom to counsel and the specifics of the
patients’ at-risk behavior patterns in order to customize
brief advice and discussion. We identified potential
participants through pre-visit telephone surveys that
used validated measures of quantity–frequency22 and
Behavioral Risk Factor Surveillance System survey ques-
tions23 to assess binge drinking and drinking and driving.
Chart flags and flow charts outlining the patients’ at-risk
behaviors (e.g., chronic drinking, binge drinking, or
driving after drinking) and discussion guidelines were
clipped to the top of patients’ medical records. As
mentioned above, prescreening and chart flagging are
now greatly facilitated by the widespread use of electronic
health records and web- or mobile-based pre-visit
screenings.
Finally, intervention delivery must also be efficient,
team-based, and in line with the tempo and competing
priorities of primary care. In the ORCA study, primary
care providers gave brief motivational advice and had a
short discussion with their patients about the health risks
associated with at-risk drinking practices. They assessed
patients’ readiness to change their drinking practices and
then customized how they introduced the self-
management support materials based on readiness.
Providers informed patients that a telephone counselor
would be calling to follow up. In the study, the behavioral
counselor was a graduate student, but an increasing focus
on team-based care and promotion of non-physician
staff practicing to the top of their licenses has carved out
a role for others to provide much of the ongoing
motivation and self-management support to patients.
Conclusions
Building from a commitment to “get practice into
research,” the ORCA study provided a rigorous evalua-
tion of a primary care feasible brief intervention to
reduce alcohol misuse. Assessing study components
against the PRECIS domains illustrates that informative
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 Ludman and Curry / Am J Prev Med 2015;49(3S2):S194–S199
primary care–based studies can include a mix of prag-
matic and explanatory features. The four-component
paradigm of population-based identification of the target
population, centralized intervention delivery, involve-
ment of primary care providers and motivators, and
personalization through tailored written feedback and
phone counseling can guide future primary care–based
behavioral counseling research.
Publication of this article was supported by the Agency for
Healthcare Research and Quality (AHRQ).
The U.S. Preventive Services Task Force (USPSTF) is an
independent, voluntary body. The U.S. Congress mandates
that AHRQ support the operations of the USPSTF.
The findings and conclusions in this document are those
of the authors, who are responsible for its content, and do not
necessarily represent the views of AHRQ or of the USPSTF. No
statement in this report should be construed as an official position
of AHRQ or the U.S. Department of Health and Human Services.
The authors were funded by NIH/National Institute on
Alcohol Abuse and Alcoholism R01AA09175 to conduct the
study reported in this manuscript. The study sponsor had no
role in study design, collection, analysis, and interpretation of
the data; writing the report; or the decision to submit the
manuscript for publication.
Administrative and logistical support for this paper was
provided by AHRQ through contract HHSA290-2010-00004i,
TO 4.
No financial disclosures were reported by the authors of
this paper.
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