Comparing Strategies for Translating Self-management Support Into Primary Care

NCT01945918 | Completed DMC

• 2 other identifiers: 12-06451R18DK096387-01
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Diabetes Mellitus; Primary Health Care; Self care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Evidence of documented self-management support for patients through medical record review

  18 months from baseline

Other Outcomes (6)

• Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months

  18 months from baseline

• Change in patient-reported physical activity from baseline to 18 months

  18 months from baseline

• Change in patient-reported tobacco use from baseline to 18 months

  18 months from baseline

Study Arms (3)

Self-management support education

ACTIVE COMPARATOR

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

Connection to Health Interactive Behavior Change Technology

ACTIVE COMPARATOR

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

Connection to Health plus Coaching

EXPERIMENTAL

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; Behavioral: Connection to Health plus Coaching (CTH+C)

Interventions

Self-management support education BEHAVIORAL

Same as Arm Description

Self-management support education

Connection to Health Interactive Behavior Change Technology BEHAVIORAL

Same as Arm Description

Connection to Health Interactive Behavior Change Technology; Connection to Health plus Coaching

Connection to Health plus Coaching (CTH+C) BEHAVIORAL

Same as Arm Description

Connection to Health plus Coaching

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Developmentally disabled
• Decisionally challenged
• Pregnant women

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of California, San Francisco: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 31464589 DERIVED

• 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.

  PMID: 30041598 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• W. Perry Dickinson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 19, 2013
• Study Start: October 1, 2013
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

US (1)