Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)

Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)

The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Diabetes Mellitus; Chronic Disease
• Intervention / Treatment: Behavioral: Prescription synchronization

• Study Type: Interventional
• Enrollment (Actual): 3675
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Woonsocket, Rhode Island, United States, 02895
      • CVS Caremark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

We will enroll patients 18 years of age and older who within 6 months of study enrollment have filled ≥ 2 medications intended for long-term use (i.e. maintenance medications) by mail order at CVS Caremark. At least 1 of these 2 medications of must be for the treatment of diabetes or cardiovascular disease. In addition, these medications must be delivered on two or more unique delivery dates, there must be at least one refill remaining for all eligible medications and either all or none of their prescriptions must be enrolled in the ReadyFill@Mail program (see Intervention Description for details).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Prescription synchronization	Behavioral: Prescription synchronization; Each patient's medication that has the greatest quantity of pills on hand after randomization will be defined as the "index "medication and partial supplies will be provided for all other eligible medications in order to synchronize all of a patient's medication. Prescribers will be contacted for a new prescription to ensure all eligible medications are on the same renewal schedule. Randomization will occur within strata of whether patients are enrolled in the "ReadyFill@Mail" program. Once synchronized, patients who are not enrolled in the ReadyFill@Mail program will initiate their own refills. Patients who are enrolled in the ReadyFill@Mail program will have their refills automatically filled, however patients may disenroll from ReadyFill@Mail at any time, in which case they will initiate their own refills. Patients may disenroll in whole or in part from the program at any point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full adherence to medications for the treatment of diabetes or cardiovascular disease	Percent of subjects achieving full adherence (defined as a Medication Possession Ratio > 80%) to medications for cardiovascular disease and diabetes	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of de-synchronization	Rate at which members whose prescriptions have been synchronized elect to discontinue with the synchronization during the study period	12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: CVS Caremark
• Investigators: Principal Investigator: Niteesh K Choudhry, MD, PhD, Brigham and Women's Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Randomized controlled trial; Medication adherence; Quality improvement; Chronic disease; Prescription synchronization; Pharmacy benefit design
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Cardiovascular Diseases; Chronic Disease
• Other Study ID Numbers: Pro00008813