A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Primary Purpose
Unhealthy Diet, Exercise, Smoking, and Alcohol Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer based care
Telephone counseling
Group visits
Usual care
Sponsored by

About this trial
This is an interventional prevention trial for Unhealthy Diet, Exercise, Smoking, and Alcohol Use focused on measuring Health Behavior, Prevention, Informatics, Electronic Health Record
Eligibility Criteria
Inclusion Criteria: All individuals over the age of 8 years presenting for care in 9 primary care practices Exclusion Criteria: None
Sites / Locations
- Riverside Physicians Associates
Outcomes
Primary Outcome Measures
Health behaviors (diet, exercise, smoking status, and alcohol use
Secondary Outcome Measures
Intervention's Reach, Adoption, Implementation, Maintenance
Full Information
NCT ID
NCT00292968
First Posted
February 15, 2006
Last Updated
July 18, 2012
Sponsor
Virginia Commonwealth University
Collaborators
Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00292968
Brief Title
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Official Title
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unhealthy Diet, Exercise, Smoking, and Alcohol Use
Keywords
Health Behavior, Prevention, Informatics, Electronic Health Record
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5670 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Computer based care
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling
Intervention Type
Behavioral
Intervention Name(s)
Group visits
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Health behaviors (diet, exercise, smoking status, and alcohol use
Time Frame
4 and 9 months post intervention
Secondary Outcome Measure Information:
Title
Intervention's Reach, Adoption, Implementation, Maintenance
Time Frame
At the time of delivery of care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All individuals over the age of 8 years presenting for care in 9 primary care practices
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Krist, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
Facility Information:
Facility Name
Riverside Physicians Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20453184
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.
Results Reference
background
PubMed Identifier
20338714
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.
Results Reference
result
PubMed Identifier
20171538
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.
Results Reference
result
PubMed Identifier
18929990
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.
Results Reference
result
PubMed Identifier
18929981
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.
Results Reference
result
Links:
URL
http://www.prescriptionforhealth.org/
Description
Source of funding - Prescription for Health Innitiative
URL
http://www.acorn.fap.vcu.edu/
Description
Practice base research network study conducting the study - ACORN
Learn more about this trial
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
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