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Kidney Disease, ChronicEPPCommNCT06182475

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

A study testing EPPComm Provider Training in people with Kidney Disease, Chronic and End Stage Renal Disease, run by Temple University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
EPPComm Provider Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesUnited States
Study dates
Sep 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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
Show all 9Show fewer
  • 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.

Who cannot join

  • (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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Heather M Gardiner, PHD contact

215-204-3294

heather.gardiner@temple.edu

Joie D Cooper, MS contact

joie.cooper@temple.edu

United States2 sites
  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

    Francis Weng, MD, 973-322-8216, Francis.Weng@rwjbh.org

  • Temple University

    Philadelphia, Pennsylvania, 19122

    Heather M Gardiner (Traino), PhD, MPH, 215-204-8330, heather.gardiner@temple.edu

Other trials in United States

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
EPPComm Provider Training
Keywords
Patient-Provider Communication, Live Donor Kideny Transplantation, Provider Training, Communication Skills Training
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPPComm Provider TrainingBehavioural

    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.

Study groups in NCT06182475
Study groupRoleWhat they receive
EPPCom Provider TrainingExperimentalA 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.
Receives: Behavioral: EPPComm Provider Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live donor inquiries

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

    Measured: Through study completion, 4 years

  2. Live donor evaluations

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

    Measured: Through study completion, 4 years

  3. Live donor kidney transplant

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

    Measured: Through study completion, 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06182475
Sponsor's protocol ID
R01DK134630
Acronym
EPPComm
Status last verified
May 2026
First submitted
18 Aug 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31335777
  • Kutner NG, Zhang R, Huang Y, Johansen KL. Impact of race on predialysis discussions and kidney transplant preemptive wait-listing. Am J Nephrol. 2012;35(4):305-11. doi: 10.1159/000336891. Epub 2012 Mar 9.

    PubMed 22414927
  • Browne T, Patzer RE, Gander J, Amamoo MA, Krisher J, Sauls L, Pastan S. Kidney transplant referral practices in southeastern dialysis units. Clin Transplant. 2016 Apr;30(4):365-71. doi: 10.1111/ctr.12693. Epub 2016 Feb 12.

    PubMed 26782140
  • Jones D, You Z, Kendrick JB. Racial/Ethnic Differences in Barriers to Kidney Transplant Evaluation among Hemodialysis Patients. Am J Nephrol. 2018;47(1):1-7. doi: 10.1159/000484484. Epub 2017 Dec 19.

    PubMed 29258094
  • Nonterah CW, Gardiner HM. Pre-transplant evaluation completion for Black/African American renal patients: Two theoretical frameworks. Patient Educ Couns. 2020 May;103(5):988-998. doi: 10.1016/j.pec.2019.11.005. Epub 2019 Nov 9.

    PubMed 31733984
  • Taber DJ, Gebregziabher M, Hunt KJ, Srinivas T, Chavin KD, Baliga PK, Egede LE. Twenty years of evolving trends in racial disparities for adult kidney transplant recipients. Kidney Int. 2016 Oct;90(4):878-87. doi: 10.1016/j.kint.2016.06.029. Epub 2016 Aug 20.

    PubMed 27555121
  • Ng YH, Pankratz VS, Leyva Y, Ford CG, Pleis JR, Kendall K, Croswell E, Dew MA, Shapiro R, Switzer GE, Unruh ML, Myaskovsky L. Does Racial Disparity in Kidney Transplant Waitlisting Persist After Accounting for Social Determinants of Health? Transplantation. 2020 Jul;104(7):1445-1455. doi: 10.1097/TP.0000000000003002.

    PubMed 31651719
  • Friedewald JJ, Samana CJ, Kasiske BL, Israni AK, Stewart D, Cherikh W, Formica RN. The kidney allocation system. Surg Clin North Am. 2013 Dec;93(6):1395-406. doi: 10.1016/j.suc.2013.08.007.

    PubMed 24206858

Questions about this trial

What is this clinical trial studying?

A study testing EPPComm Provider Training in people with Kidney Disease, Chronic and End Stage Renal Disease, run by Temple University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heather M Gardiner, PHD (215-204-3294, heather.gardiner@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live donor inquiries (time frame: Through study completion, 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06182475, which also lists 158 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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