What this study is
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.
What's being tested
- CO-LEAD
Intervention · 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.
Study details
- Official title
- Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
- Sponsor
- Duke University
- Conditions
- Systemic Lupus Erythematosus
- Enrolling
- 480 people
- Starts
- 2024-07-01
- Est. completion
- 2028-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedClinician
You may qualify if
- Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions
- Clinicians who have ambulatory rheumatology care at least ½ day per week
You can't join if
- Clinicians at Duke University who were involved in the investigators' pilot work
- Clinicians with an anticipated departure from the institution in the 12 months following enrollment
Patient
You may qualify if
- 18 years or older
- English-speaking, able to provide consent
- Diagnosed with SLE and receiving care with enrolled clinicians
- Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR.
You can't join if
- Non-English speakers
- Patients who are prescribed only corticosteroids for SLE
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
Duke University
Study ID Pro00115358
Principal investigator
Kai Sun, MD
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.