Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

August 4, 2023 updated by: Kaiser Permanente
The investigators propose a randomized encouragement trial to encourage use of the existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adherence to effective cardiovascular disease (CVD) risk factor medications is associated with improved CVD risk factor control, fewer hospitalizations, and lower mortality in patients with diabetes. However, many patients are poorly adherent to medications, and there are persistent racial/ethnic and socioeconomic disparities in medication adherence. Traditional clinical trials of interventions to improve medication adherence are often resource-intensive, and focus exclusively on patient-level barriers to behavior change. Unsurprisingly, these trials have not led to sustainable, cost-effective approaches to improve adherence. Health system-level medication adherence interventions that can be implemented, "scaled up," and sustained across a wide range of health care delivery settings are urgently needed. The investigators propose a randomized encouragement trial to encourage use of existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications and who only use retail pharmacies in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii. These combined systems include approximately 300,000 patients with diabetes with diverse racial/ethnic and socioeconomic backgrounds. Patients with no history of mail order pharmacy use will be randomized into 2 arms. In addition to examining the impact of the intervention on medication adherence and CVD risk factor control, the investigators will examine factors affecting the sustainability and dissemination of the intervention, assess the intervention's impact on utilization and health care costs, and determine whether the intervention's impact differs across racial/ethnic and socioeconomic subgroups. This research will provide a foundation for developing sustainable, system-level approaches to addressing medication adherence in diabetes patients that can be widely disseminated and implemented across a diverse array of health care systems.

Study Type

Interventional

Enrollment (Actual)

63012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94501
        • Division of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies),
  • Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months
  • Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months

Exclusion Criteria:

  • Pregnancy or Dementia/Traumatic Brain Injury diagnosis in the prior 12 months
  • Hospitalized, in Skilled Nursing Facility, Hospice, or Home Health at the time of randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Behavioral: Standardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Experimental: Usual care
Behavioral: Usual care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention
Time Frame: 12 months following the date of outreach into the intervention
users of the mail order pharmacy service - if they utilized the mail order system to deliver medications anytime in the 12 months following the date of outreach into the intervention
12 months following the date of outreach into the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Harvard Pilgrim Health Care

Investigators

  • Principal Investigator: Julie A Schmittdiel, Research Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimated)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CN-14-1947
  • R18DK104249 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe