Comparing Strategies for Translating Self-management Support Into Primary Care
NCT ID: NCT01945918
Last Updated: 2017-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
901 participants
INTERVENTIONAL
2013-10-31
2017-07-31
Brief Summary
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Detailed Description
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* Primary Specific Aims
1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.
2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.
* Secondary Specific Aims
1. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.
2. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Self-management support education
Project staff will meet onsite with practice clinicians for a two-hour session to discuss what self-management support (SMS) is, why it is important, how primary care plays a role in this process, how others have approached it, and how it can be time and cost efficient for them to engage in SMS as part of standard diabetes care. Practices will have access to a website displaying general and local SMS resources. Discussion of the implementation of these resources into the practice will be facilitated. Two additional academic detailing visits will be made to check on progress on SMS adoption, provide additional information as needed, and answer questions. No input will be provided regarding how unique practice characteristics might be utilized for more effective implementation of SMS, and CTH will not be introduced.
Self-management support education
Same as Arm Description
Connection to Health Interactive Behavior Change Technology
Connection to Health (CTH) Arm: The number and length of staff visits to these practices will be the same as for the SMS Education Arm, but the content of the visits will center on the implementation and use of the CTH program as a way to implement SMS. Clinicians and selected staff members will be given hands-on experience using the system and will be provided with scenarios that will highlight the effective use of CTH as a tool for diabetes SMS. The practices will then implement CTH, using protocols selected from several suggested by the research team. Additional technical assistance with implementing CTH will also be provided as needed.
Connection to Health Interactive Behavior Change Technology
Same as Arm Description
Connection to Health plus Coaching
Connection to Health plus Coaching (CTH+C) Arm: This arm adds practice coaching as described above to CTH. The active coaching phase focuses on meetings of the practice improvement team, scheduled every other week for approximately 40 minutes each. The improvement team will consist of 6 - 10 diverse representatives of the practice (e.g., front office, medical assistants, physicians). The coach will assist the team in developing a CTH adoption plan and then help them break it down into small bites for rapid cycle change using the Plan-Do-Study-Act quality improvement (QI) model. Active coaching will last for 3 months, followed by monthly calls by the coach to review data regarding the practice's use of CTH and brief "booster" coaching to deal with problems.
Connection to Health Interactive Behavior Change Technology
Same as Arm Description
Connection to Health plus Coaching (CTH+C)
Same as Arm Description
Interventions
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Self-management support education
Same as Arm Description
Connection to Health Interactive Behavior Change Technology
Same as Arm Description
Connection to Health plus Coaching (CTH+C)
Same as Arm Description
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
* Able to read in English or Spanish
* Plan to remain in the practice during the study period
Exclusion Criteria
* Decisionally challenged
* Pregnant women
21 Years
89 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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W. Perry Dickinson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States
Countries
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References
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Hessler DM, Fisher L, Bowyer V, Dickinson LM, Jortberg BT, Kwan B, Fernald DH, Simpson M, Dickinson WP. Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection. BMC Fam Pract. 2019 Aug 29;20(1):120. doi: 10.1186/s12875-019-1012-x.
Dickinson WP, Dickinson LM, Jortberg BT, Hessler DM, Fernald DH, Fisher L. A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices. BMC Fam Pract. 2018 Jul 24;19(1):126. doi: 10.1186/s12875-018-0810-x.
Other Identifiers
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12-0645
Identifier Type: -
Identifier Source: org_study_id