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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CVS Caremark
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01963156
First received: October 10, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chronic Disease
Cardiovascular Disease
Diabetes Mellitus
Behavioral: Prescription synchronization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percent of subjects achieving full adherence (defined as a Medication Possession Ratio > 80%) to medications for cardiovascular disease and diabetes


Other Outcome Measures:
  • Rates of de-synchronization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Rate at which members whose prescriptions have been synchronized elect to discontinue with the synchronization during the study period


Enrollment: 3675
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963156

Locations
United States, Rhode Island
CVS Caremark
Woonsocket, Rhode Island, United States, 02895
Sponsors and Collaborators
Brigham and Women's Hospital
CVS Caremark
Investigators
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
  More Information

No publications provided

Responsible Party: Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01963156     History of Changes
Other Study ID Numbers: Pro00008813
Study First Received: October 10, 2013
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Prescription synchronization
Cardiovascular disease
Medication adherence
Randomized controlled trial
Chronic disease
Pharmacy benefit design
Quality improvement

Additional relevant MeSH terms:
Cardiovascular Diseases
Chronic Disease
Diabetes Mellitus
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014