Implementing "Explore Transplant"- A Pilot Study

NCT03046732 | Completed

• 1 other identifier: 16-5314-AE
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT has been associated with better quality of life (QOL) \[1-3\], reduced morbidity and mortality\[4, 5\], and reduced healthcare costs\[6\]. Studies in the US have shown that patients receiving tailored transplant education were more likely to complete the transplant evaluation \[9, 14, 15\]. For instance, patients receiving the Explore Transplant (ET) education program designed by Dr. Waterman, were more knowledgeable about KT and more likely to complete KT evaluation than control patients. Currently, there is a lack of standardized KT education in Ontario. Traditional approaches have been insufficient in providing the necessary education and information to enable patients to make an informed decision about their care. To address this issue, the study will assess the impact of kidney transplant related education using the Explore Transplant Ontario (ETO) education program on kidney transplant-related knowledge and on readiness to consider KT, readiness to consider living donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis. In order to comprehensively measure this impact, 5 variables will be explored.

1. 1.Readiness to consider DDKT
2. 2.Readiness to consider LDKT
3. 3.KT related knowledge in patients
4. 4.Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after administration of ETO
5. 5.Proportion of patients who have identified at least one potential living donor at 6 and 12 months after administration of ETO
6. 6.Readiness to consider DDKT will be higher in the "intervention" group compared to the "control" group at follow up.
7. 7.Readiness to consider LDKT will be higher in the "intervention" group compared to the "control" group at follow up.
8. 8.The KT related knowledge of the patients will be higher in the "intervention" group compared to the "control" group at follow up.
9. 9.The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
10. 10.The proportion of patients who have at least one potential living donor at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.

Conditions

Endstage Kidney Disease

Keywords

Kidney Transplant Education; Transplant Readiness; Living Donor Kidney Transplant; Chronic Kidney Disease; End Stage Kidney Disease; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients in "early stages" of kidney transplant readiness

  An average of 1 year and a half

Study Arms (2)

Explore Transplant Ontario

EXPERIMENTAL

Intervention 'Implementing "Explore Transplant" Education'

Other: Implementing "Explore Transplant" Education

Control

NO INTERVENTION

The control arm (Usual Treatment) is at the Toronto General Hospital dialysis center.

Interventions

Implementing "Explore Transplant" Education OTHER

The "Explore Transplant Ontario" (ETO) education program

Explore Transplant Ontario

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years, \< 80 years
• Patients undergoing maintenance hemodialysis for more than 3 months
• Able to understand English at a grade 5 level
• Those willing and able to provide informed consent

You may not qualify if:

• Patients with severe acute illness or condition that hampers questionnaire completion
• Dementia indicated in the medical record, indicated by the managing healthcare team
• Dialysis initiation between 0-90 days prior to enrollment
• Current, active malignancy or a history of malignancy within 2 years of successful treatment
• Current active chronic infection that is an absolute contraindication to kidney transplantation
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (31)

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• Waterman AD, Peipert JD, Hyland SS, McCabe MS, Schenk EA, Liu J. Modifiable patient characteristics and racial disparities in evaluation completion and living donor transplant. Clin J Am Soc Nephrol. 2013 Jun;8(6):995-1002. doi: 10.2215/CJN.08880812. Epub 2013 Mar 21.

  PMID: 23520044 BACKGROUND

• Vamos EP, Csepanyi G, Zambo M, Molnar MZ, Rethelyi J, Kovacs A, Marton A, Nemeth Z, Novak M, Mucsi I. Sociodemographic factors and patient perceptions are associated with attitudes to kidney transplantation among haemodialysis patients. Nephrol Dial Transplant. 2009 Feb;24(2):653-60. doi: 10.1093/ndt/gfn660. Epub 2008 Nov 30.

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• Olbrisch ME, Benedict SM, Haller DL, Levenson JL. Psychosocial assessment of living organ donors: clinical and ethical considerations. Prog Transplant. 2001 Mar;11(1):40-9. doi: 10.1177/152692480101100107.

  PMID: 11357556 BACKGROUND

• Kasiske BL. The evaluation of prospective renal transplant recipients and living donors. Surg Clin North Am. 1998 Feb;78(1):27-39. doi: 10.1016/s0039-6109(05)70632-0.

  PMID: 9531933 BACKGROUND

• Rodrigue JR, Paek MJ, Egbuna O, Waterman AD, Schold JD, Pavlakis M, Mandelbrot DA. Making house calls increases living donor inquiries and evaluations for blacks on the kidney transplant waiting list. Transplantation. 2014 Nov 15;98(9):979-86. doi: 10.1097/TP.0000000000000165.

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• Rodrigue JR, Pavlakis M, Egbuna O, Paek M, Waterman AD, Mandelbrot DA. The "House Calls" trial: a randomized controlled trial to reduce racial disparities in live donor kidney transplantation: rationale and design. Contemp Clin Trials. 2012 Jul;33(4):811-8. doi: 10.1016/j.cct.2012.03.015. Epub 2012 Apr 3.

  PMID: 22510472 BACKGROUND

• Weng FL, Brown DR, Peipert JD, Holland B, Waterman AD. Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates. BMC Nephrol. 2013 Nov 19;14:256. doi: 10.1186/1471-2369-14-256.

  PMID: 24245948 BACKGROUND

• Waterman AD, Robbins ML, Paiva AL, Hyland SS. Kidney patients' intention to receive a deceased donor transplant: development of stage of change, decisional balance and self-efficacy measures. J Health Psychol. 2010 Apr;15(3):436-45. doi: 10.1177/1359105309351248.

  PMID: 20348364 BACKGROUND

• Terasaki PI, Cecka JM, Gjertson DW, Takemoto S. High survival rates of kidney transplants from spousal and living unrelated donors. N Engl J Med. 1995 Aug 10;333(6):333-6. doi: 10.1056/NEJM199508103330601.

  PMID: 7609748 BACKGROUND

• Waterman AD, Stanley SL, Covelli T, Hazel E, Hong BA, Brennan DC. Living donation decision making: recipients' concerns and educational needs. Prog Transplant. 2006 Mar;16(1):17-23. doi: 10.1177/152692480601600105.

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• Pradel FG, Mullins CD, Bartlett ST. Exploring donors' and recipients' attitudes about living donor kidney transplantation. Prog Transplant. 2003 Sep;13(3):203-10. doi: 10.1177/152692480301300307.

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• Waterman AD, Rodrigue JR, Purnell TS, Ladin K, Boulware LE. Addressing racial and ethnic disparities in live donor kidney transplantation: priorities for research and intervention. Semin Nephrol. 2010 Jan;30(1):90-8. doi: 10.1016/j.semnephrol.2009.10.010.

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• DePasquale N, Ephraim PL, Ameling J, Lewis-Boyer L, Crews DC, Greer RC, Rabb H, Powe NR, Jaar BG, Gimenez L, Auguste P, Jenckes M, Boulware LE. Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study. BMC Nephrol. 2013 Jan 14;14:9. doi: 10.1186/1471-2369-14-9.

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• Hall KL, Robbins ML, Paiva A, Knott JE, Harris L, Mattice B. Donation intentions among African American college students: decisional balance and self-efficacy measures. J Behav Med. 2007 Dec;30(6):483-95. doi: 10.1007/s10865-007-9121-8. Epub 2007 Aug 3.

  PMID: 17674183 BACKGROUND

• Waterman AD, Dew MA, Davis CL, McCabe M, Wainright JL, Forland CL, Bolton L, Cooper M. Living-donor follow-up attitudes and practices in U.S. kidney and liver donor programs. Transplantation. 2013 Mar 27;95(6):883-8. doi: 10.1097/TP.0b013e31828279fd.

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• Waterman AD, Robbins ML, Paiva AL, Peipert JD, Davis LA, Hyland SS, Schenk EA, Baldwin KA, Amoyal NR. Measuring kidney patients' motivation to pursue living donor kidney transplant: development of stage of change, decisional balance and self-efficacy measures. J Health Psychol. 2015 Feb;20(2):210-21. doi: 10.1177/1359105313501707. Epub 2013 Oct 22.

  PMID: 24155194 BACKGROUND

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  PMID: 3558716 BACKGROUND

• Christensen, A.J., et al., Quality of life in end-stage renal disease: Influence of renal transplantation. Clin Transplant, 1989. 3: p. 46-53

  BACKGROUND

• Information, C.I.H.I., 2014 CORR Report: Treatment of End-Stage Organ Failure in Canada, 2003 to 2012. 2014.

  BACKGROUND

• Report, T.-H.T., We ask because we care- The Tri-Hospital + TPH Health Equity Data Collection Research Project Report. 2013: p. 51.

  BACKGROUND

Related Links

• Canada, S. Classificiation of population group 2009 \[cited 2015 August 5th, 2015\]

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

• Istvan Mucsi

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant Nephrologist

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 8, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CA (2)