Clinical trial NCT02192255: SUPREME-DM (Diabetes Mellitis) Treatment Study
Official title: An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes type 2
primary care
chronic disease care improvement
adherence, randomized trial
BP control
lipid control
glucose control
natural language processing.
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-07-16
Enrollment: 2378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 60 day Medication Adherence
timeFrame: 60 days
measure: 120 day medication adherence
timeFrame: 120 days
Secondary outcomes:
measure: Composite Control Level of Blood pressure, A1c and/or LDL
timeFrame: 180 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: HealthPartners Institute for Education and Research
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Patrick J. O'Connor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.