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

Official title

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

Overview

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.

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 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.

Interventions

• 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 discussion

Primary outcome measures

• Live donor inquiries [Time frame: Through study completion, 4 years]
• Live donor evaluations [Time frame: Through study completion, 4 years]
• Live donor kidney transplant [Time frame: Through study completion, 4 years]

Eligibility criteria

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:

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• Cooperman Barnabas Medical Center — Livingston
• Temple University — Philadelphia

Publications

• United States Renal Data System. 2020 USRDS annual data report: Epidemiology of kidney disease in the United States. Executive Summary. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2020. https://adr.usrds.org/2020. Accessed February 1, 2022.
• Haller MC, Kammer M, Oberbauer R. Dialysis vintage and outcomes in renal transplantation. Nephrol Dial Transplant. 2019 Apr 1;34(4):555-560. doi: 10.1093/ndt/gfy099. PMID 29897595
• Kaballo MA, Canney M, O'Kelly P, Williams Y, O'Seaghdha CM, Conlon PJ. A comparative analysis of survival of patients on dialysis and after kidney transplantation. Clin Kidney J. 2018 Jun;11(3):389-393. doi: 10.1093/ckj/sfx117. Epub 2017 Oct 18. PMID 29942504
• Wyld M, Morton RL, Hayen A, Howard K, Webster AC. A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease treatments. PLoS Med. 2012;9(9):e1001307. doi: 10.1371/journal.pmed.1001307. Epub 2012 Sep 11. PMID 22984353
• Organ Procurement and Transplantation Network. U.S. Department of Health and Human Services. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/#. Accessed February 1, 2022.
• United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018. https://www.usrds.org/2018/view/Default.aspx. Accessed February 1, 2022.
• Navaneethan SD, Singh S. A systematic review of barriers in access to renal transplantation among African Americans in the United States. Clin Transplant. 2006 Nov-Dec;20(6):769-75. doi: 10.1111/j.1399-0012.2006.00568.x. PMID 17100728
• Waterman AD, Peipert JD, Xiao H, Goalby CJ, Kawakita S, Cui Y, Lentine KL. Education Strategies in Dialysis Centers Associated With Increased Transplant Wait-listing Rates. Transplantation. 2020 Feb;104(2):335-342. doi: 10.1097/TP.0000000000002781. PMID 31335777

Identifiers

NCT: NCT06182475 · R01DK134630

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗