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Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction

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ClinicalTrials.gov Identifier: NCT03848884
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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

Condition or disease Intervention/treatment Phase
Adherence, Patient Behavioral: Adherence monitoring and education Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : October 16, 2019
Actual Study Completion Date : October 16, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Adherence monitoring and education Behavioral: Adherence monitoring and education
Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848884


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Jean-Venable Goode, PharmD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03848884    
Other Study ID Numbers: HM20014333
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No