Synchronization to Improve Non-Adherence to Cardiovascular Medications

NCT01963156 | Terminated

• 1 other identifier: Pro00008813
• Study Type: interventional
• Target: 3,675
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease; Cardiovascular Disease; Diabetes Mellitus

Keywords

Prescription synchronization; Cardiovascular disease; Medication adherence; Randomized controlled trial; Chronic disease; Pharmacy benefit design; Quality improvement

Outcome Measures

Primary Outcomes (1)

• Medication adherence

  Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims

  12 months

Secondary Outcomes (1)

• Full adherence to medications for the treatment of diabetes or cardiovascular disease

  12 months

Other Outcomes (1)

• Rates of de-synchronization

  12 months

Study Arms (2)

Prescription synchronization

EXPERIMENTAL

Behavioral: Prescription synchronization

Control

NO INTERVENTION

Interventions

Prescription synchronization BEHAVIORAL

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.

Prescription synchronization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• CVS Caremark: collaborator

Study Sites (1)

CVS Caremark

Woonsocket, Rhode Island, 02895, United States

Location

MeSH Terms

Conditions

Chronic Disease; Cardiovascular Diseases; Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)