NCT03738826

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 27, 2021

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

November 6, 2018

Results QC Date

May 27, 2021

Last Update Submit

June 13, 2025

Conditions

Keywords

medication adherence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Medication Adherence as Determined by Self Report

    12 weeks

  • Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)

    Baseline, 12 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention

Interventions

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All followup patients seen at the Duke Lupus clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Sun K, Eudy AM, Rogers JL, Criscione-Schreiber LG, Sadun RE, Doss J, Maheswaranathan M, Barr AC, Eder L, Corneli AL, Bosworth HB, Clowse MEB. Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. Arthritis Care Res (Hoboken). 2023 Mar;75(3):550-558. doi: 10.1002/acr.24806. Epub 2022 Nov 11.

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMedication Adherence

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Kai Sun, M.D.
Organization
Duke University

Study Officials

  • Kai Sun

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 13, 2018

Study Start

October 2, 2019

Primary Completion

June 7, 2020

Study Completion

June 7, 2020

Last Updated

June 17, 2025

Results First Posted

July 27, 2021

Record last verified: 2025-06

Locations