Medication Adherence in Rheumatic Diseases

Improving Medication Adherence in Chronic Rheumatic Diseases

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rheumatic Diseases
• Intervention / Treatment: Behavioral: Clinician-led adherence intervention

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate		4 weeks
Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)	Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible.	4 weeks
Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills	Calculated for the full population, not per participant.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)	Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, where 5 is most acceptable.	4 weeks
Intervention 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 following provider visit.	4 weeks
Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies	This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients.	4 weeks
Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies		4 weeks
Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample	MPR is calculated by dividing the number of days all patients were covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change for the entire sample.	Baseline to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MPR (Medication Possession Ratio) as a Percentage	MPR is calculated by dividing the number of days a patient is covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kai Sun, MD, MS, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): June 22, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: Pro00108618

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