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Intervention to Improve Communication and Medication Adherence in Lupus
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.
Conditions:
🦠 Systemic Lupus Erythematosus
🗓️ Study Start (Actual) 30 June 2024
🗓️ Primary Completion (Estimated) July 2027
✅ Study Completion (Estimated) December 2028
👥 Enrollment (Estimated) 480
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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

    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

    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.

    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
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 June 2024
  • First Submitted that Met QC Criteria 10 June 2024
  • First Posted 13 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified June 2024
I'm interested ...!!