Pharmacy Interventions to Improve Chronic Disease Medication Refill

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469365
• Other study ID #: P01HS010871
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2007
• Last updated: November 25, 2008
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: May 2007
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3048
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Diabetes
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Psychoses

Intervention

Behavioral:
• pharmacist contact with the patient via telephone

• Pharmacist contact with the patient's physician via fax

• Usual care

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.