The Medication Adherence Program (MAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Association of Diabetes Educators
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00838344
First received: February 5, 2009
Last updated: September 28, 2009
Last verified: September 2009
  Purpose

In this study, the investigators will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care progress, and provide intervention to resolve any barriers to taking prescribed medicines. The hypothesis for the study is that personalized telephone follow-up by a pharmacist will assist people who have missed refilling their prescriptions in taking diabetes medicines by resolving medication adherence challenges. Following randomization, the intervention will be offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for prescribed DM medicine refills by at least 6 days. Control subjects will receive usual pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide medication adherence support to intervention subjects for 12 months following enrollment with the goal of improving medication refilling and persistence.


Condition Intervention
Treatment
Diabetes
Other: Medication Adherence Program (MAP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: The Medication Adherence Program:Promoting Diabetes Self-Management Through Community Pharmacies

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medication adherence challenges [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: April 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Usual prescription refill system and pharmacy care.
Experimental: Intervention
Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.
Other: Medication Adherence Program (MAP)
Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.

Detailed Description:

Taking medicines can be a challenge for those with diabetes mellitus (DM) with adherence rates to DM medicines as low as 31%. Adherence to DM medicines improves DM by reducing blood glucose (ie A1c reduction) but will also result in improved outcomes, reduced cardiovascular risks, and reduced costs of diabetes. The most common factors reported to affect medication taking in those with DM include difficulty remembering refills and doses, regimen complexity (e.g more than one DM drug, need to split tablets, mix products), dosing frequency greater than twice daily, depression, and adverse effects or fear of them.

Pharmacists have immense opportunity to interact with people with DM, who now number over 20 million in the United States (US). This reality is due to several factors including convenience of pharmacies (found in most urban, suburban, and rural communities), accessibility of pharmacists for questions and counseling (appointments not usually required), and strong rapport that pharmacists and their staff develop with long-term patients and their families through their presence in the community. Pharmacists in community practices work directly with patients and review refill information about patient medication use thus allowing for personalized, immediate, and ongoing promotion of adherence. Currently, pharmacists do not routinely call patients who are overdue for prescription refills to ascertain if the refill is still needed or proactively work to resolve any barriers to refilling. The standard of care is to provide refill and medication adherence support if it is requested by a patient and if the pharmacy is able to provide the needed level of support.

In this study, we will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call by a pharmacist to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines and provide intervention to resolve any barriers.

  Eligibility

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

Inclusion Criteria:

  • 18 or older with type 2 diabetes on at least one oral diabetes medication who have missed a refill by 6 or more days

Exclusion Criteria:

  • Those unable to converse in the same language as their usual care Safeway pharmacist (Spanish or English most common languages spoken at the site stores) or who do not have an interpreter, family member, friend, or caregiver who can act on the subject's behalf as an interpreter during the initial or any follow-up phone calls
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838344

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
American Association of Diabetes Educators
  More Information

No publications provided

Responsible Party: Peggy Odegard, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00838344     History of Changes
Other Study ID Numbers: 33084-D, 07-9030-D-01, RFA0100-06
Study First Received: February 5, 2009
Last Updated: September 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
medication adherence
medication persistence
pharmacist interventions
diabetes
persistence
adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014