SUPREME-DM (Diabetes Mellitis) Treatment Study

NCT ID: NCT02192255

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-03-31

Brief Summary

This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.

Detailed Description

This randomized trial tested the hypothesis that a telephone contact with a patient recently prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b) medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or low-density lipoprotein cholesterol control. This study was part of the larger Agency for Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was coordinated and led by HealthPartners Institute for Education and Research, while data collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger Clinic.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention phone call

The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted \< than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.

Group Type: EXPERIMENTAL

Intervention Phone Call

Intervention Type: BEHAVIORAL

The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted \< than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.

Control arm - usual care

Those in the control arm received usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention Phone Call

The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted \< than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At each clinical intervention site, study subjects were selected if they:

• were age 18-75 years
• met study criteria for diabetes mellitus before study enrollment
• received clinical care at a designated clinic or medical center involved in this study for at least 15 months before enrollment
• were prescribed a new class of medication (not filled in the past 180 days) for A1c, BP, or LDL that was uncontrolled at the time of medication prescription (A1c>=8%, systolic BP>= 140 mm Hg, or LDL >=100 mg/dL).

Exclusion Criteria

• Study subjects were excluded if they were younger than 18 years of age
• Older than 75 years of age
• Did not have evidence of diabetes mellitus prior to study enrollment
• Were not receiving care at a clinic site involved in this study for at least 15 months before enrollment
• Did not have prescribed a new class of medication for uncontrolled A1c, BP or LDL.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J. O'Connor, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Institute for Education and Research

Minneapolis, Minnesota, United States

Countries

United States

References

O'Connor PJ, Schmittdiel JA, Pathak RD, Harris RI, Newton KM, Ohnsorg KA, Heisler M, Sterrett AT, Xu S, Dyer WT, Raebel MA, Thomas A, Schroeder EB, Desai JR, Steiner JF. Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care. 2014 Dec;37(12):3317-24. doi: 10.2337/dc14-0596. Epub 2014 Oct 14.

Reference Type: DERIVED

PMID: 25315207 (View on PubMed)

Other Identifiers

10-018

Identifier Type: -

Identifier Source: org_study_id