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Comparing Strategies for Translating Self-management Support Into Primary Care

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-management support education
Connection to Health Interactive Behavior Change Technology
Connection to Health plus Coaching (CTH+C)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado at Denver and Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Self-management support education

Connection to Health Interactive Behavior Change Technology

Connection to Health plus Coaching

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline to 18 months
Glycosylated hemoglobin (HbA1c) will be measured at baseline and 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).
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)
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)

Secondary Outcome Measures

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.

Full Information

First Posted
August 27, 2013
Last Updated
December 18, 2017
Sponsor
University of Colorado, Denver
Collaborators
University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01945918
Brief Title
Comparing Strategies for Translating Self-management Support Into Primary Care
Official Title
Comparing Strategies for Translating Self-management Support Into Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management support education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Connection to Health Interactive Behavior Change Technology
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Connection to Health plus Coaching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-management support education
Intervention Description
Same as Arm Description
Intervention Type
Behavioral
Intervention Name(s)
Connection to Health Interactive Behavior Change Technology
Intervention Description
Same as Arm Description
Intervention Type
Behavioral
Intervention Name(s)
Connection to Health plus Coaching (CTH+C)
Intervention Description
Same as Arm Description
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline to 18 months
Description
Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.
Time Frame
18 months from baseline
Title
Change in LDL from baseline to 18 months
Description
Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).
Time Frame
18 months from baseline
Title
Change in systolic and diastolic blood pressure from baseline to 18 months
Description
Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)
Time Frame
18 months from baseline
Title
Change in body mass index (BMI) from baseline to 18 months
Description
Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / [height (m)]2; e.g., 24.96)
Time Frame
18 months from baseline
Secondary Outcome Measure Information:
Title
Evidence of documented self-management support for patients through medical record review
Description
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.
Time Frame
18 months from baseline
Other Pre-specified Outcome Measures:
Title
Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months
Description
Patients' dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages will be assessed at baseline and 18 months from baseline through a patient-completed survey on their diet.
Time Frame
18 months from baseline
Title
Change in patient-reported physical activity from baseline to 18 months
Description
Patients' frequency and duration of participation in vigorous, moderate, and walking activity as well as "screen" time and time spent sitting will be assessed at baseline and 18 months from baseline through a patient-completed survey on their physical activity.
Time Frame
18 months from baseline
Title
Change in patient-reported tobacco use from baseline to 18 months
Description
Patients' use of tobacco (whether or not using tobacco, if so, how much; e.g., current smoker [yes/no]; number of cigarettes [10 in the past week]) will be assessed at baseline and 18 months from baseline through a patient-completed survey.
Time Frame
18 months from baseline
Title
Change in patient-reported medication adherence from baseline to 18 months
Description
Patients' prescribed medication adherence (number of days missed, reasons for missing) will be assessed at baseline and 18 months from baseline through a patient-completed survey.
Time Frame
18 months from baseline
Title
Change in patient-reported disease-related distress rating from baseline to 18 months
Description
Patients' distress related to their diabetes (6-point scales for each item; mean score calculated for each sub-scale [range between 1 and 6]) will be assessed at baseline and 18 months from baseline through a patient-completed survey.
Time Frame
18 months from baseline
Title
Change in patient-reported diabetes self-care rating from baseline to 18 months
Description
Patients' measure of the frequency of performing diabetes self-care tasks over the preceding 7 days will be assessed at baseline and 18 months from baseline through a patient-completed survey.
Time Frame
18 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Perry Dickinson, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver and Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31464589
Citation
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.
Results Reference
derived
PubMed Identifier
30041598
Citation
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.
Results Reference
derived

Learn more about this trial

Comparing Strategies for Translating Self-management Support Into Primary Care

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