Back to resultsReducing Disparities in Medication Adherence in SLE
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Systemic Lupus Erythematosus focused on measuring medication adherence
Eligibility Criteria
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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Lupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Medication Adherence as Determined by Self Report
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.
Full Information
NCT ID
NCT03738826
First Posted
November 6, 2018
Last Updated
July 8, 2021
Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03738826
Brief Title
Reducing Disparities in Medication Adherence in SLE
Official Title
Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
June 7, 2020 (Actual)
Study Completion Date
June 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
medication adherence
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
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Lupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence
Description
Feasibility as measured by documentation of adherence assessment made by provider.
Time Frame
12 weeks
Title
Acceptability as Measured by Provider Survey
Description
Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Medication Adherence as Determined by Self Report
Time Frame
12 weeks
Title
Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)
Description
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.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Sun
Organizational Affiliation
Duke University
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
Undecided
Learn more about this trial
Reducing Disparities in Medication Adherence in SLE
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