A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2006 | ||||
| Last Updated Date | July 18, 2012 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Health behaviors (diet, exercise, smoking status, and alcohol use [ Time Frame: 4 and 9 months post intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Health behaviors (diet, exercise, smoking status, and alcohol use) | ||||
| Change History | Complete list of historical versions of study NCT00292968 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Intervention's Reach, Adoption, Implementation, Maintenance [ Time Frame: At the time of delivery of care ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Intervention's Reach, Adoption, Implementation, Maintenance | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors | ||||
| Official Title ICMJE | A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Unhealthy Diet, Exercise, Smoking, and Alcohol Use | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5670 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All individuals over the age of 8 years presenting for care in 9 primary care practices Exclusion Criteria: None |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00292968 | ||||
| Other Study ID Numbers ICMJE | 6268 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Virginia Commonwealth University | ||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Virginia Commonwealth University | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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