Clinical trial NCT06458075: Intervention to Improve Communication and Medication Adherence in Lupus
Official title: Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-06-13
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Frequency of adherence discussions
timeFrame: During intervention period (up to 2 years)
Secondary outcomes:
measure: Quality of patient-clinician communication determined by audio recordings
timeFrame: During intervention period (up to 2 years)
measure: Quality of patient-clinician communication determined by surveys
timeFrame: During intervention period (up to 2 years)
measure: Change in SLE medication adherence
timeFrame: Baseline and post-intervention (up to 6 months)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kai Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: