Clinical trial NCT00292968: A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Official title: A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unhealthy Diet, Exercise, Smoking, and Alcohol Use
Keywords: Health Behavior
Prevention
Informatics
Electronic Health Record
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-02-16
Enrollment: 5670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.

Detailed description: We posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. They must be comprehensive (addressing multiple behaviors and the "5 As"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the Chronic Care Model. We will test the effectiveness and implementation of an innovative "packaged" intervention with these features. Six ACORN-affiliated practices will adopt a brief (3 minute) routine to deliver A1-3 (Ask, Advise, Agree) in the office and to offer patients four options for intensive assistance (Assist \[A4\], Arrange \[A5\]) outside the office. Patients can select 9 months of online, telephone, or group counseling; or usual care. An electronic health record (EHR) will expedite the in-office intervention and referrals. Outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from EHR data, "counselee" surveys, and patient/staff interviews). We hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the Common Measures for physical activity, diet, smoking, and alcohol use). EHR-captured data will measure RE-AIM parameters, including Reach (14 sub-measures), Adoption, and Maintenance. Surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore Implementation issues and suggested improvements. We hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. Accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. We strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. If our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.

Eligibility criteria: Inclusion Criteria:

All individuals over the age of 8 years presenting for care in 9 primary care practices

Exclusion Criteria:

None

Primary outcomes:
measure: Health behaviors (diet, exercise, smoking status, and alcohol use
timeFrame: 4 and 9 months post intervention
Secondary outcomes:
measure: Intervention's Reach, Adoption, Implementation, Maintenance
timeFrame: At the time of delivery of care
Other outcomes:
Locations:
city: Newport News
country: United States
facility: Riverside Physicians Associates
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alex Krist, MD
role: STUDY_DIRECTOR
References:
citation: Krist AH, Cifuentes M, Dodoo MS, Green LA. Measuring primary care expenses. J Am Board Fam Med. 2010 May-Jun;23(3):376-83. doi: 10.3122/jabfm.2010.03.090089.
citation: Wilson DB, Johnson RE, Jones RM, Krist AH, Woolf SH, Flores SK. Patient weight counseling choices and outcomes following a primary care and community collaborative intervention. Patient Educ Couns. 2010 Jun;79(3):338-43. doi: 10.1016/j.pec.2010.01.025. Epub 2010 Mar 24.
citation: Krist AH, Woolf SH, Johnson RE, Rothemich SF, Cunningham TD, Jones RM, Wilson DB, Devers KJ. Patient costs as a barrier to intensive health behavior counseling. Am J Prev Med. 2010 Mar;38(3):344-8. doi: 10.1016/j.amepre.2009.11.010.
citation: Dodoo MS, Krist AH, Cifuentes M, Green LA. Start-up and incremental practice expenses for behavior change interventions in primary care. Am J Prev Med. 2008 Nov;35(5 Suppl):S423-30. doi: 10.1016/j.amepre.2008.08.007.
citation: Krist AH, Woolf SH, Frazier CO, Johnson RE, Rothemich SF, Wilson DB, Devers KJ, Kerns JW. An electronic linkage system for health behavior counseling effect on delivery of the 5A's. Am J Prev Med. 2008 Nov;35(5 Suppl):S350-8. doi: 10.1016/j.amepre.2008.08.010.