Reducing Disparities in Medication Adherence in SLE

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03738826
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 135
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 16.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Behavioral: Behavioral Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
• Actual Study Start Date: Oct 2, 2019
• Actual Primary Completion Date: Jun 7, 2020
• Actual Study Completion Date: Jun 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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; 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence [12 weeks]

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

2. Acceptability as Measured by Provider Survey [12 weeks]

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

Secondary Outcome Measures

1. Medication Adherence as Determined by Self Report [12 weeks]

2. Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) [Baseline, 12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• National Institute on Minority Health and Health Disparities (NIMHD)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Kai Sun, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03738826
• Other Study ID Numbers: Pro00100861; 5U54MD012530-02
• First Posted: Nov 13, 2018
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: medication adherence
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
Period Title: Overall Study
STARTED	130	5
COMPLETED	130	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers	Total
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.	Total of all reporting groups
Overall Participants	130	5	135
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.0 (14.0)	42.0 (4.9)	43 (7)
Sex: Female, Male (Count of Participants)
Female	123 94.6%	4 80%	127 94.1%
Male	7 5.4%	1 20%	8 5.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.3%	0 0%	3 2.2%
Not Hispanic or Latino	127 97.7%	5 100%	132 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%	0 0%	1 0.7%
Asian	4 3.1%	1 20%	5 3.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	71 54.6%	0 0%	71 52.6%
White	54 41.5%	4 80%	58 43%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	130 100%	5 100%	135 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
Measure Participants	130	0
Count of Participants [Participants]	116 89.2%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
Measure Participants	0	5
Mean (Standard Deviation) [score on a scale]	4.4 (0.6)

3. Secondary Outcome

Title	Medication Adherence as Determined by Self Report
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
Measure Participants	0	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Behavioral Intervention	Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
Measure Participants	130	0
Baseline (prior to intervention)	46 35.4%
12 weeks (after intervention)	55 42.3%

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Collected via chart review of clinic visit during which the intervention was performed.
Arm/Group Title	Behavioral Intervention		Lupus Clinic Providers
Arm/Group 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. 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 will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
All Cause Mortality
	Behavioral Intervention		Lupus Clinic Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/5 (0%)
Serious Adverse Events
	Behavioral Intervention		Lupus Clinic Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Intervention		Lupus Clinic Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.