Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469365
Status:
COMPLETED
Last Update Posted:
2008-11-26
First Post:
2007-05-03
Brief Title:
Pharmacy Interventions to Improve Chronic Disease Medication Refill
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Randomized Controlled Trial of Two Pharmacy Interventions to Improve Refill Adherence for Chronic Disease Medications
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 raceethnicity and socioeconomic background Individual pharmacy staff were informed by their district manager PP 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 ie 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 armsAfter 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 careThere were a total of 3048 patients into arms 1 n1018 2 n1016 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None