- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192255
SUPREME-DM (Diabetes Mellitis) Treatment Study
July 15, 2014 updated by: HealthPartners Institute
An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
2378
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55425
- HealthPartners Institute for Education and Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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NO_INTERVENTION: Control arm - usual care
Those in the control arm received usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
60 day Medication Adherence
Time Frame: 60 days
|
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,
|
60 days
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120 day medication adherence
Time Frame: 120 days
|
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,
|
120 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Control Level of Blood pressure, A1c and/or LDL
Time Frame: 180 days
|
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
|
180 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J. O'Connor, MD, MPH, HealthPartners Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
July 15, 2014
First Posted (ESTIMATE)
July 16, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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