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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03848884
Other study ID # HM20014333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date October 16, 2019

Study information

Verified date October 2019
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 16, 2019
Est. primary completion date October 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. 18 years or older

2. Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC < 80%

3. Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)

Exclusion Criteria:

1. Patients who are enrolled in MedSync or Autorefill program

2. Patients who are lost to follow-up

3. Incomplete/missing documentation of an encounter

4. Prisoners, children

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adherence monitoring and education
Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction with education and monitoring service "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
Primary Adherence in oral diabetes medications determined by star ratings 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
Primary Adherence in renin-angiotensin system antagonists (RASA) medications determined by star ratings 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 Change in proportion of days covered (PDC) 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
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