Synchronization to Improve Non-Adherence to Cardiovascular Medications

Diabetes Mellitus Clinical Trial

— SyNCMed  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01963156
• Other study ID #: Pro00008813
• Status: Terminated
• Phase: N/A
• First received: October 10, 2013
• Last updated: January 7, 2016
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3675
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Disease
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	CVS Caremark	Woonsocket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	CVS Caremark

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Medication adherence	Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims	12 months	No
Secondary	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	No