Comparing Strategies for Translating Self-management Support Into Primary Care

Study Overview
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Brief Summary
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This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.

Detailed Description
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The specific aims of the proposed study are: Primary Specific Aims 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. 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 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. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.

Official Title
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Comparing Strategies for Translating Self-management Support Into Primary Care

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Self-management support education
* Behavioral: Connection to Health Interactive Behavior Change Technology
* Behavioral: Connection to Health plus Coaching (CTH+C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years old or over 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: Developmentally disabled Decisionally challenged Pregnant women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-management support education<br>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. | Behavioral: Self-management support education<br>* Same as Arm Description<br>|
| Active Comparator: Connection to Health Interactive Behavior Change Technology<br>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. | Behavioral: Connection to Health Interactive Behavior Change Technology<br>* Same as Arm Description<br>|
| Experimental: Connection to Health plus Coaching<br>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. | Behavioral: Connection to Health Interactive Behavior Change Technology<br>* Same as Arm Description<br>Behavioral: Connection to Health plus Coaching (CTH+C)<br>* Same as Arm Description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to 18 months | Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline. | 18 months from baseline | 
| Change in LDL from baseline to 18 months | Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL). | 18 months from baseline | 
| Change in systolic and diastolic blood pressure from baseline to 18 months | Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg) | 18 months from baseline | 
| Change in body mass index (BMI) from baseline to 18 months | Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / [height (m)]2; e.g., 24.96) | 18 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of documented self-management support for patients through medical record review | The following elements will be assessed in medical record review: presence of a personal care plan with regular updating, evidence of collaborative goal setting, evidence of action planning around prioritized patient goals, evidence of collaborative problem-solving regarding the action planning process, use of community resources to assist in goal attainment, and evidence of ongoing monitoring of progress on identified goals. A total score will be the sum of positive elements. | 18 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care