Medication Adherence in Rheumatic Diseases

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06018350
Collaborator
(none)
12
1
1
8
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Clinician-led adherence intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Medication Adherence in Chronic Rheumatic Diseases
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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.

Behavioral: Clinician-led adherence intervention
The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient

Outcome Measures

Primary Outcome Measures

  1. Intervention Feasibility [4 weeks]

    Percent of providers agreeing to participate

  2. Intervention Feasibility [4 weeks]

    Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible

  3. Intervention Feasibility [4 weeks]

    Percent of visits with EMR documentation of providers reviewing refills

Secondary Outcome Measures

  1. Acceptability [4 weeks]

    Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable

  2. Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers [4 weeks]

    Patient survey will be administered after their provider visit

  3. Fidelity [4 weeks]

    Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies

  4. Fidelity [4 weeks]

    Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies

  5. Change in medication adherence [baseline, 3 months]

    90-day medication possession ratio at 3 months after the intervention visit compared to baseline

  6. Change in medication adherence [baseline, 6 months]

    90-day medication possession ratio at 6 months after the intervention visit compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Kai Sun, MD, MS, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT06018350
Other Study ID Numbers:
  • Pro00108618
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023