A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292968
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : July 20, 2012
Robert Wood Johnson Foundation
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Unhealthy Diet, Exercise, Smoking, and Alcohol Use Behavioral: Computer based care Behavioral: Telephone counseling Behavioral: Group visits Behavioral: Usual care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5670 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Study Start Date : June 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Health behaviors (diet, exercise, smoking status, and alcohol use [ Time Frame: 4 and 9 months post intervention ]

Secondary Outcome Measures :
  1. Intervention's Reach, Adoption, Implementation, Maintenance [ Time Frame: At the time of delivery of care ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292968

United States, Virginia
Riverside Physicians Associates
Newport News, Virginia, United States, 23666
Sponsors and Collaborators
Virginia Commonwealth University
Robert Wood Johnson Foundation
Agency for Healthcare Research and Quality (AHRQ)
Study Director: Alex Krist, MD Virginia Commonwealth University

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Virginia Commonwealth University Identifier: NCT00292968     History of Changes
Other Study ID Numbers: 6268
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by Virginia Commonwealth University:
Health Behavior
Electronic Health Record