Development and Test of a Communication Skills Training for Transplant Providers - Aims 2 & 3

NCT06182475 | Not Yet Recruiting

• 1 other identifier: R01DK134630
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Disease, Chronic; End Stage Renal Disease; Kidney Replacement

Keywords

Patient-Provider Communication; Live Donor Kideny Transplantation; Provider Training; Communication Skills Training

Outcome Measures

Primary Outcomes (3)

• Live donor inquiries

  Whether potential donors return a completed donor referral form to the patient's transplant program (yes/no)

  Through study completion, 4 years

• Live donor evaluations

  Whether potential donor appears, in-person, for the donor evaluation (yes/no)

  Through study completion, 4 years

• Live donor kidney transplant

  Whether patient receives a live donor kidney transplant (yes/no)

  Through study completion, 4 years

Study Arms (1)

EPPCom Provider Training

EXPERIMENTAL

A highly engaging and interactive 60-minute, in-person communication skills training program will be developed as part of this project. Participating transplant providers will complete a brief online survey before (pre) and after (post) participating in the training.

Behavioral: EPPComm Provider Training

Interventions

EPPComm Provider Training BEHAVIORAL

A curriculum will be developed to educate patients about LDKT and promote the search of potential living donors while supporting patients' values and cultural preferences. The curriculum will consist of two components: didactic education and skills-based communication. The didactic component provides evidence of the impact of patient-provider communication and LDKT process outcomes for Black and Caucasian patients. The skills-based component will build communication confidence leading discussions about LDKT. It provides instructions for the key communication skills needed to confidently assuage patients' concerns about LDKT/live donation and motivates patients to search for living donor. The following will be covered: providing LDKT information/answering questions, highlighting LDKT benefits, refuting live donation misinformation, and encouraging patients to seek living donors.

EPPCom Provider Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) appear for a kidney transplant evaluation at Cooperman Barnabas Medical Center (CBMC) or Temple University Hospital (TUH)
• (2) speak English
• (3) be of self-reported Black or Caucasian ethnicity
• (4) be ≥18 years of age.
• Including patients who:
• have received prior kidney transplants
• patients with limited English proficiency, as long as they speak with the physician via a translator
• patients evaluated at offsite satellite locations that are not actually at CBMC or TUHS.
• All transplant nephrologists, nurses, and social workers employed at the kidney transplant programs at CBMC and TUH who are actively involved in patient evaluations for transplant will be eligible for participation in the study. Providers refusing to permit digital audio recording of the transplant consultation will be deemed ineligible.

You may not qualify if:

• (1) are non-verbal or otherwise unable to converse with providers
• (2) are already listed for kidney transplant at CBMC or TUHS or at another transplant center
• (3) have limited English proficiency and speak directly with the physician in a language other than English.
• Patients having (1) received an offer to donate a kidney from a family member or friend, or (2) explicitly asked a family member or friend to consider serving as a LD will be excluded, along with any patients refusing to permit digital audio recording of the transplant consultation will also be deemed ineligible to participate.
• The following special populations will be excluded: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), prisoners, and individuals who do not understand English.
• It is unlikely that any female patient will be pregnant while awaiting kidney transplant; however, we will not exclude pregnant women.

Sponsors & Collaborators

• Temple University: lead
• Cooperman Barnabas Medical Center: collaborator

Study Sites (2)

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis Weng, MD

  St. Barnabas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather M Gardiner, PHD

CONTACT

215-204-3294; heather.gardiner@temple.edu

Joie D Cooper, MS

CONTACT

joie.cooper@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: To provide preliminary data on the efficacy and acceptability of the training program, we will employ a pre-post study design, with providers serving as their own controls (Aim 2). We will then test the indirect effects of the training on providers' communication with patients, patient and provider factors and live donor kidney transplant process outcomes.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)