- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03848884
Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction
October 16, 2019 updated by: Virginia Commonwealth University
Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate if a monthly adherence monitoring and education service impacts the percent of patients adherent to oral diabetes and renin-angiotensin system antagonists (RASA) medications based on star ratings.
It will also evaluate patient satisfaction of the adherence monitoring and education service, using a standard questionnaire.
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC < 80%
- Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)
Exclusion Criteria:
- Patients who are enrolled in MedSync or Autorefill program
- Patients who are lost to follow-up
- Incomplete/missing documentation of an encounter
- Prisoners, children
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adherence monitoring and education
|
Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence in oral diabetes medications determined by star ratings
Time Frame: Baseline to 6 months
|
Determine change in patients who are adherent to oral diabetes medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study.
A student t-test will be used to determine if there is a difference.
|
Baseline to 6 months
|
|
Adherence in renin-angiotensin system antagonists (RASA) medications determined by star ratings
Time Frame: Baseline to 6 months
|
Determine change in patients who are adherent to RASA medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study.
A student t-test will be used to determine if there is a difference.
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proportion of days covered (PDC)
Time Frame: Baseline to 6 months
|
Determine change in PDC after monthly follow-up on medication adherence and education; pharmacy analytics determines patient PDC in normal practice.
The mean PDC for each patient at the end of the six-month study period will be compared to the baseline using a student t-test.
|
Baseline to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with education and monitoring service
Time Frame: 6 months
|
"Patient Satisfaction Survey" includes an 8-item 5-point likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree) about whether or not the pharmacist provided adequate education to the patient, whether or not the patient feels his/her health benefited from the service, and if the patient would recommend the service.
The "Patient Satisfaction Survey" will be analyzed using descriptive statistics to determine how satisfied patients were with the medication adherence monitoring and education service.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Venable Goode, PharmD, Virginia Commonwealth University
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)
March 1, 2019
Primary Completion (Actual)
October 16, 2019
Study Completion (Actual)
October 16, 2019
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 18, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- HM20014333
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.
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