A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00292968
First received: February 15, 2006
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention
Unhealthy Diet, Exercise, Smoking, and Alcohol Use
Behavioral: Computer based care
Behavioral: Telephone counseling
Behavioral: Group visits
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Health behaviors (diet, exercise, smoking status, and alcohol use [ Time Frame: 4 and 9 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intervention's Reach, Adoption, Implementation, Maintenance [ Time Frame: At the time of delivery of care ] [ Designated as safety issue: No ]

Enrollment: 5670
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00292968

Locations
United States, Virginia
Riverside Physicians Associates
Newport News, Virginia, United States, 23666
Sponsors and Collaborators
Virginia Commonwealth University
Robert Wood Johnson Foundation
Investigators
Study Director: Alex Krist, MD Virginia Commonwealth University
  More Information

Additional Information:
Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00292968     History of Changes
Other Study ID Numbers: 6268
Study First Received: February 15, 2006
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014