Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182475
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-08-18
Brief Title:
Development and Test of a Communication Skills Training for Transplant Providers - Aims 2 3
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Increasing Equity in Live Donor Kidney Transplantation Through Effective Patient-Provider Communication
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
EPPComm
Brief Summary:
The goal of this clinical trial is to understand the communication occurring between Black and Caucasian patients and their transplant providers during transplant evaluation consultations and assess relationships between these communicative elements and patient and provider factors patient-reported outcomes and living donor transplant outcomes - living donor referrals evaluations and transplants We will use these findings to inform the development of a communication skills training for transplant providers and test the impact of the training on providers communication about live donor kidney transplants with Black and Caucasian patients and living donor transplant outcomes
The main questions it aims to answer are
How does the use of the use of instrumental relational and affective communication by patients and providers during the transplant consultation differ by patient and provider factors patient-reported outcomes and patient ethnicity
What elements of instrumental relational and affective communication will be predictive of live donor kidney transplant LDKT process outcomes LD inquiries and evaluations and actual LDKTs
Participants will be asked to complete brief surveys before and after the transplant consultation and to give permission for the consultation to be audiorecorded
This data will be used to develop a training to educate providers on the key communication factors predictive of LDKT process outcomes specific to Black and Caucasian patients and provide guidance on their application during patient consultations Researchers will then compare communication and patient-reported and LDKT process outcomes between trained and untrained providers to see whether the training has any effect on living donor inquiries and evaluations and actual LDKTs
The main questions it aims to answer are
How does the use of the use of instrumental relational and affective communication by patients and providers during the transplant consultation differ by patient and provider factors patient-reported outcomes and patient ethnicity
What elements of instrumental relational and affective communication will be predictive of live donor kidney transplant LDKT process outcomes LD inquiries and evaluations and actual LDKTs
Participants will be asked to complete brief surveys before and after the transplant consultation and to give permission for the consultation to be audiorecorded
This data will be used to develop a training to educate providers on the key communication factors predictive of LDKT process outcomes specific to Black and Caucasian patients and provide guidance on their application during patient consultations Researchers will then compare communication and patient-reported and LDKT process outcomes between trained and untrained providers to see whether the training has any effect on living donor inquiries and evaluations and actual LDKTs
Detailed Description:
Live donor kidney transplant LDKT is the preferred treatment modality for patients with chronic and end-stage kidney disease LDKT is less expensive than prolonged dialysis and offers improved mortality and morbidity over either dialysis or deceased donor kidney transplants DDKT However ethnic minorities have significantly less access to LDKT than their White counterparts Collectively Blacks Asians and Hispanics represent 643 of the kidney transplant wait list yet received only 36 of all LDKTs in 2019 Further rates of LDKTs have decreased for Black patients over the last decade Decades of research point to patient-provider communication as a contributing factor to observed disparities in health and healthcare outcomes To date however no attempt has been made to gauge the impact of the communication occurring during transplant evaluation consultations on LDKT outcomes The long-term goal of the proposed study entitled Increasing Equity in Live Donor Kidney Transplant through Effective Patient-Provider Communication is to increase parity in access to LDKT for Black patients A community-engaged mixed-methods study employing a concurrent triangulation design is proposed to identify the specific communicative behaviors that result in live donor inquiries and evaluations and actual LDKTs for Caucasian and Black patients providing critical information to the design of an intervention to improve patient-provider communication about LDKT Specifically this project will simultaneously quantitatively assess patient and provider factors with established and hypothesized associations with receipt of LDKTs and qualitatively assess discrete elements of patient-provider communication occurring during transplant evaluation consultations for Caucasian and Black patients Aim 1 Brief quantitative surveys administered before and after medical consultations held as part of the evaluation for transplant candidacy will capture providers N52 confidence and comfort discussing LDKT and patients satisfaction with the consultation medical mistrust health literacy and LDKT knowledge attitudes and readiness In addition transplant evaluation consultations will be evaluated for 60 Caucasian and 60 Black patients N120 across the two study sites - Saint Barnabas Medical Center NJ and Temple University Hospital PA and qualitatively assess the communication occurring during the consultations The findings will be used to inform development of the content and format of a communication skills training for transplant providers and evaluate the direct and indirect effects of the training on patient-reported and LDKT process outcomes Aims 2 3 Intervening at the provider level is both practical given that all transplant candidates already must undergo this consultation and efficient given that a single transplant physician can evaluate 100 transplant candidates per year Thus the results of this innovative study have the potential to increase access to LDKT for Black patients currently awaiting kidney transplant Improving communication during the transplant consultation may prove to be an effective and efficient means of alleviating ethnic disparities in LDKT
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