Increasing Equity in Live Donor Kidney Transplantation Through Effective Patient-Provider Communication

End Stage Renal Disease Clinical Trial

— EPPComm  

Official title:

Increasing Equity in Live Donor Kidney Transplantation Through Effective Patient-Provider Communication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182475
• Other study ID #: R01DK134630
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: Heather M Gardiner, PHD
• Phone: 215-204-3294
• Email: heather.gardiner[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 64.3% 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' (N=52) 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 (N=120) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 193
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (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:

1. have received prior kidney transplants

2. patients with limited English proficiency, as long as they speak with the physician via a translator

3. 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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Replacement
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• EPPComm Provider Training
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.

Locations

Country	Name	City	State
United States	Cooperman Barnabas Medical Center	Livingston	New Jersey
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	St. Barnabas Medical Center

Country where clinical trial is conducted

United States, 

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* Note: There are 158 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Live donor evaluations	Whether potential donor appears, in-person, for the donor evaluation (yes/no)	Through study completion, 4 years
Primary	Live donor kidney transplant	Whether patient receives a live donor kidney transplant (yes/no)	Through study completion, 4 years