Intervention to Improve Communication and Medication Adherence in Lupus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Clinician

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.Clinician

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.Patient

Inclusion Criteria:

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. Patient

Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06458075
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kai Sun, MD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Additional Details

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.

Arms & Interventions

Arms

No Intervention: Control

Control clinicians will continue usual care.

Active Comparator: CO-LEAD

CO-LEAD clinicians will receive training in the intervention.

Interventions

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27710

Site Contact

Kai Sun

[email protected]

919- 681- 7417