Trial Outcomes & Findings for Reducing Disparities in Medication Adherence in SLE (NCT NCT03738826)

NCT ID: NCT03738826

Last Updated: 2025-06-17

Results Overview

Feasibility as measured by documentation of adherence assessment made by provider.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 135 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-06-17

Participant Flow

Patients were recruited over 12 clinic sessions between 9/25/19-1/25/20 from an academic lupus clinic, which takes place 1 half-day a week.

Participant milestones

Measure	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. 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.	Lupus Clinic Providers 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.
Overall Study STARTED	130	5
Overall Study COMPLETED	130	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Disparities in Medication Adherence in SLE

Baseline characteristics by cohort

Measure	Behavioral Intervention n=130 Participants 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. 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.	Lupus Clinic Providers n=5 Participants 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.	Total n=135 Participants Total of all reporting groups
Age, Continuous	44.0 years STANDARD_DEVIATION 14.0 • n=5 Participants	42.0 years STANDARD_DEVIATION 4.9 • n=7 Participants	43 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	4 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	5 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	71 Participants n=5 Participants	0 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	4 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	130 Participants n=5 Participants	5 Participants n=7 Participants	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Data for this outcome measure collected on the Behavioral Intervention group only.

Feasibility as measured by documentation of adherence assessment made by provider.

Outcome measures

Measure	Behavioral Intervention n=130 Participants 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. 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.	Lupus Clinic Providers 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.
Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence	116 Participants	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Data for this outcome measure collected on the Lupus Clinic Providers group only.

Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable.

Outcome measures

Measure	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. 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.	Lupus Clinic Providers n=5 Participants 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.
Acceptability as Measured by Provider Survey	—	4.4 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Data for this outcome measure collected on the Behavioral Intervention group only.

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.

Outcome measures

Measure	Behavioral Intervention n=130 Participants 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. 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.	Lupus Clinic Providers 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.
Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) Baseline (prior to intervention)	46 percentage of participants	—
Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) 12 weeks (after intervention)	55 percentage of participants	—

Adverse Events

Behavioral Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lupus Clinic Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kai Sun, M.D.

Duke University

Phone: 919-681-7417

Email: kai.sun@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place