Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458075
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Intervention to Improve Communication and Medication Adherence in Lupus
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus SLE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO-LEAD
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MD018977-01 | NIH | None | httpsreporternihgovquickSearch1R01MD018977-01 |