SUPREME-DM (Diabetes Mellitis) Treatment Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT02192255
First received: June 12, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Intervention Phone Call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • 60 day Medication Adherence [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (a) first medication fill within 60 days of prescription,

  • 120 day medication adherence [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, Blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (b) >=2 medication fills within 180 days of prescription,


Secondary Outcome Measures:
  • Composite Control Level of Blood pressure, A1c and/or LDL [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, Blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (c) clinically significant improvement in a composite measure of A1c, Blood pressure, or low-density lipoprotein cholesterol


Enrollment: 2378
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
No Intervention: Control arm - usual care
Those in the control arm received usual care.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02192255

Locations
United States, Minnesota
HealthPartners Institute for Education and Research
Minneapolis, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Patrick J. O'Connor, MD, MPH HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT02192255     History of Changes
Other Study ID Numbers: 10-018
Study First Received: June 12, 2014
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Keywords provided by HealthPartners Institute for Education and Research:
diabetes type 2
primary care
chronic disease care improvement
adherence, randomized trial
BP control
lipid control
glucose control
natural language processing.

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014