Reducing Disparities in Medication Adherence in SLE

Systemic Lupus Erythematosus Clinical Trial

Official title:

Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738826
• Other study ID #: Pro00100861
• Secondary ID: 5U54MD012530-02
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: June 7, 2020

Study information

• Verified date: July 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 7, 2020
• Est. primary completion date: June 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• All followup patients seen at the Duke Lupus clinic

Exclusion Criteria

• Patients not seen at the Duke Lupus Clinic

• New patients seen for the first time at the Duke Lupus Clinic

• Patients who are not prescribed any lupus medications

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• Behavioral Intervention
Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence	Feasibility as measured by documentation of adherence assessment made by provider.	12 weeks
Primary	Acceptability as Measured by Provider Survey	Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable.	12 weeks
Secondary	Medication Adherence as Determined by Self Report		12 weeks
Secondary	Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)	Medication Possession Ratio (MPR) = days with medication/total days. This will be determined by pharmacy refill data and calculated for 3 months (90 days). An MPR > or = 80% indicates adherence.	Baseline, 12 weeks