Intervention to Improve Communication and Medication Adherence in Lupus

NCT ID: NCT06458075

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-12-31

Brief Summary

CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).

The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:

1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.

2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.

Detailed Description

Substantial racial disparities exist in patients with systemic lupus erythematosus (SLE), a disease that markedly reduces life expectancy and quality of life. Long-term, consistent use of immune-altering medicines is critical for treating symptoms and preventing organ damage from SLE, but Black patients have lower medication adherence. While reasons for nonadherence are complex, Black patients with SLE are disproportionately affected by motivational barriers related to their beliefs, attitudes, and trust. Effective and collaborative patient-clinician communication can lead to more honest exchange of information, strengthen trust and therapeutic alliance, and thereby increase medication adherence and improve health outcomes. Unfortunately, effective patient-clinician discussions about nonadherence occur sporadically, and Black patients experience worse communication with their clinicians. Existing adherence interventions in SLE do not address patient-clinician communication nor focus on reducing racial disparities.

In this study, clinicians will go through training on how to assess medication adherence and communicate more effectively with this population. Clinicians will familiarize with EMR pharmacy refill data and the DOSE-Nonadherence-SLE questionnaire, a validated measure of the extent of and reasons for nonadherence. Clinicians will practice having a medication nonadherence discussion with another clinician in the intervention arm and give each other feedback after the practice. Clinicians will also be provided with resource handouts for medication adherence. The training will increase clinicians' confidence in conducting the intervention, and gain empathy role-playing as the patient. CO-LEAD team members will observe and give feedback to clinicians in real time.

The study will assess both communication and adherence outcomes.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

Control clinicians will continue usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CO-LEAD

CO-LEAD clinicians will receive training in the intervention.

Group Type: ACTIVE_COMPARATOR

CO-LEAD

Intervention Type: BEHAVIORAL

The investigators will provide clinicians with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill data and the DOSE-Nonadherence-SLE survey, and engage and formulate solutions to adherence barriers together. The study team will provide the clinician intervention training in-person or virtually and will include didactics, demonstration, and practice that include two one-hour sessions one month apart. After training, CO-LEAD clinicians will be encouraged to incorporate the intervention in regular clinic visits with all patients.

Interventions

CO-LEAD

The investigators will provide clinicians with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill data and the DOSE-Nonadherence-SLE survey, and engage and formulate solutions to adherence barriers together. The study team will provide the clinician intervention training in-person or virtually and will include didactics, demonstration, and practice that include two one-hour sessions one month apart. After training, CO-LEAD clinicians will be encouraged to incorporate the intervention in regular clinic visits with all patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions

2. Clinicians who have ambulatory rheumatology care at least ½ day per week

1. 18 years or older

2. English-speaking, able to provide consent

3. Diagnosed with SLE and receiving care with enrolled clinicians

4. Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR.

Exclusion Criteria

1. Clinicians at Duke University who were involved in the investigators' pilot work

2. Clinicians with an anticipated departure from the institution in the 12 months following enrollment

1. Non-English speakers

2. Patients who are prescribed only corticosteroids for SLE

3. Patients who are accompanied by third-party member that is not willing or able to remain in the waiting room during the patient's visit and

• Does not wish to be audio recorded
• A minor without a parental/legal guardian and/or
• Unable to give consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kai Sun, MD

Role: CONTACT

kai.sun@duke.edu

919- 681- 7417

Kathyrn Pollak, PhD

Role: CONTACT

Kathyrn.Pollak@duke.edu

919-681-4757

Facility Contacts

Kai Sun

Role: primary

kai.sun@duke.edu

Other Identifiers

1R01MD018977-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00115358

Identifier Type: -

Identifier Source: org_study_id