Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)
Primary Purpose
Chronic Disease, Cardiovascular Disease, Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescription synchronization
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease focused on measuring Prescription synchronization, Cardiovascular disease, Medication adherence, Randomized controlled trial, Chronic disease, Pharmacy benefit design, Quality improvement
Eligibility Criteria
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).
Sites / Locations
- CVS Caremark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prescription synchronization
Control
Arm Description
Outcomes
Primary Outcome Measures
Medication adherence
Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01963156
First Posted
October 10, 2013
Last Updated
January 7, 2016
Sponsor
Brigham and Women's Hospital
Collaborators
CVS Caremark
1. Study Identification
Unique Protocol Identification Number
NCT01963156
Brief Title
Synchronization to Improve Non-Adherence to Cardiovascular Medications
Acronym
SyNCMed
Official Title
Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
CVS Caremark
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Cardiovascular Disease, Diabetes Mellitus
Keywords
Prescription synchronization, Cardiovascular disease, Medication adherence, Randomized controlled trial, Chronic disease, Pharmacy benefit design, Quality improvement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3675 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prescription synchronization
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Prescription synchronization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication adherence
Description
Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Full adherence to medications for the treatment of diabetes or cardiovascular disease
Description
Percent of subjects achieving full adherence (defined as a Medication Possession Ratio > 80%) to medications for cardiovascular disease and diabetes
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Rates of de-synchronization
Description
Rate at which members whose prescriptions have been synchronized elect to discontinue with the synchronization during the study period
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
CVS Caremark
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Synchronization to Improve Non-Adherence to Cardiovascular Medications
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