Back to resultsMedication Adherence in Rheumatic Diseases
Primary Purpose
Chronic Rheumatic Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician-led adherence intervention
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Rheumatic Diseases
Eligibility Criteria
Inclusion Criteria: all providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis Exclusion Criteria: new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease. Patients seen by these clinicians will contribute to the outcome data collection.
Outcomes
Primary Outcome Measures
Intervention Feasibility
Percent of providers agreeing to participate
Intervention Feasibility
Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible
Intervention Feasibility
Percent of visits with EMR documentation of providers reviewing refills
Secondary Outcome Measures
Acceptability
Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable
Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers
Patient survey will be administered after their provider visit
Fidelity
Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies
Fidelity
Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies
Change in medication adherence
90-day medication possession ratio at 3 months after the intervention visit compared to baseline
Change in medication adherence
90-day medication possession ratio at 6 months after the intervention visit compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06018350
Brief Title
Medication Adherence in Rheumatic Diseases
Official Title
Improving Medication Adherence in Chronic Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rheumatic Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease.
Patients seen by these clinicians will contribute to the outcome data collection.
Intervention Type
Behavioral
Intervention Name(s)
Clinician-led adherence intervention
Intervention Description
The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient
Primary Outcome Measure Information:
Title
Intervention Feasibility
Description
Percent of providers agreeing to participate
Time Frame
4 weeks
Title
Intervention Feasibility
Description
Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible
Time Frame
4 weeks
Title
Intervention Feasibility
Description
Percent of visits with EMR documentation of providers reviewing refills
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable
Time Frame
4 weeks
Title
Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers
Description
Patient survey will be administered after their provider visit
Time Frame
4 weeks
Title
Fidelity
Description
Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies
Time Frame
4 weeks
Title
Fidelity
Description
Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies
Time Frame
4 weeks
Title
Change in medication adherence
Description
90-day medication possession ratio at 3 months after the intervention visit compared to baseline
Time Frame
baseline, 3 months
Title
Change in medication adherence
Description
90-day medication possession ratio at 6 months after the intervention visit compared to baseline
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis
Exclusion Criteria:
new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Sun, MD, MS
Phone
919 681 7405
Email
kai.sun@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Sun, MD, MS
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Medication Adherence in Rheumatic Diseases
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