Pharmacy Interventions to Improve Chronic Disease Medication Refill

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00469365
First received: May 3, 2007
Last updated: November 25, 2008
Last verified: May 2007
  Purpose

Compare the effectiveness of 3 strategies by pharmacists to decrease the time to refill of prescriptions for common chronic diseases (diabetes, hypertension, hyperlipidemia, heart failure, depression, psychoses).


Condition Intervention Phase
Diabetes
Hypertension
Hyperlipidemia
Heart Diseases
Depression
Psychoses
Behavioral: pharmacist contact with the patient via telephone
Behavioral: Pharmacist contact with the patient's physician via fax
Behavioral: Usual care
Phase 3

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: A Randomized Controlled Trial of Two Pharmacy Interventions to Improve Refill Adherence for Chronic Disease Medications

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • The primary outcome was the number of days from the index date until the next date on which the patient filled a prescription for any qualified medication, or until the end of the study follow-up period.

Secondary Outcome Measures:
  • Secondary outcomes included indicators for whether the patient filled any medication within 30 days for their chronic disease, and whether the patient filled any medication within 30 days.

Enrollment: 3048
Study Start Date: January 2006
Study Completion Date: August 2006
Detailed Description:

The design was a multi-site 8-month randomized, controlled clinical trial with the patient as the unit of randomization. The Institutional Review Board at the Medical University of South Carolina approved the study. The setting included 9 pharmacies within a medium-sized grocery store chain in South Carolina. The 9 pharmacies were selected to ensure an adequate sample size and sufficient representation by patients with respect to geographic region (urban, suburban, and rural), race/ethnicity, and socioeconomic background. Individual pharmacy staff were informed by their district manager (P.P.) that they were required to participate in the project. Beginning January 16, 2006 and continuing through August 29, 2006, all patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e. every Monday morning) using the centralized computer database. Patients identified as being overdue for a qualified medication were assigned a unique study identification number and randomized using a simple randomization technique operationalized within a Microsoft® Access® database. The randomization was based on a permuted block design with a block size of 3, with each patient thus having a one-third chance of being placed in any one of the 3 treatment arms.After eligible patients were identified and randomized each week, there were 3 different protocols followed, depending on the assigned treatment arm. The 3 treatment arms included 1) pharmacist contact with the patient via telephone, 2) pharmacist contact with the prescribing physician via facsimile, and 3) usual care.There were a total of 3,048 patients into arms 1 (n=1018), 2 (n=1016), and 3 (n= 1014). The study was designed to detect relatively small differences in the outcomes of interest. Baseline comparisons across treatment arms in the characteristics of patients and medications were made using t-tests and chi-square tests, as appropriate. For the analyses of study outcomes, an intent-to-treat approach was used. Statistical models were constructed to compare outcomes among the 3 treatment arms, after first examining whether significant interaction between treatment arm and medication disease classification was present. For the analyses of secondary outcomes, all of which were binary in nature, multivariable logistic regression models were used, with treatment arm as the key independent variable of interest, adjusting for the same covariates used in the primary analyses.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e. every Monday morning) using the centralized computer database. A qualified prescription was defined as having at least 2 refills remaining, a duration of at least a 30 days' supply, and having been written for any one of a number of chronic disease medications identified by a clinical pharmacist (A.M.W.). The medications of interest were those indicated for chronic treatment of diabetes mellitus, hypertension, hyperlipidemia, heart failure, depression, and psychoses. Medications that treat any combination of the specified diseases were allowed.
  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: NCT00469365

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Paul J Nietert, PhD Medical University of South Carolina
Study Director: Barbara C Tilley, PhD Medical University of South Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00469365     History of Changes
Other Study ID Numbers: P01 HS10871
Study First Received: May 3, 2007
Last Updated: November 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
clinical trial, medication adherence, pharmacy intervention
Patients with specific chronic diseases

Additional relevant MeSH terms:
Chronic Disease
Depression
Depressive Disorder
Heart Diseases
Hyperlipidemias
Hypertension
Mental Disorders
Psychotic Disorders
Disease Attributes
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 28, 2014