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Intervention to Improve Communication and Medication Adherence in Lupus

Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CO-LEAD, a program to help people with systemic lupus erythematosus (SLE), or lupus, talk with their care team and take medicines as prescribed. It trains clinicians to discuss pharmacy refill records and uses a patient survey to find and address problems with taking medicines. The study is for adults with lupus and clinicians who treat them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Clinicians: Provide adult rheumatology care, which treats lupus and similar diseases, at one of the two study centers as a staff doctor, advanced practice provider, or doctor in fellowship training.
  • Clinicians: See patients in a rheumatology clinic at least half a day each week.
  • Patients: Are age 18 or older.
  • Patients: Speak English and can give consent to join.
  • Patients: Have SLE and get care from a clinician in the study.
  • Patients: Have at least one prescribed lupus medicine and fill lupus prescriptions at a pharmacy whose Surescripts refill reports can be seen in the Epic electronic health record.

Who can't join

  • Clinicians: Work at Duke University and took part in the research team's earlier pilot study.
  • Clinicians: Expect to leave their study center within 12 months after joining.
  • Patients: Do not speak English.
  • Patients: Are prescribed only corticosteroids, a type of steroid medicine, for lupus.
  • Patients: Bring someone who cannot or will not stay in the waiting room and who refuses audio recording, is a minor without a parent or legal guardian, or cannot give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC