Explore Transplant at Home: Improving Low-Income ESRD Patients' Transplant Knowledge

NCT02268682 | Completed DMC

• 1 other identifier: R39OT26843
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplantation, especially living donor kidney transplant (LDKT), offers patients in end-stage renal disease (ESRD) 3 to 17 additional years of life and improved quality-of-life compared to remaining on dialysis. Unfortunately, LDKT education in dialysis centers occurs inconsistently, especially for minorities and those who are socioeconomically disadvantaged. To ensure more informed transplant decision-making, through a previous HRSA grant, Dr. Waterman designed the Explore Transplant (ET) education program based on the Transtheoretical Model of Behavioral Change. Through a previous trial, an earlier version of ET, delivered face-to-face with patients while they were undergoing dialysis, was shown to increase patients' DDKT and LDKT knowledge. However, additional research exploring dialysis providers' ability to integrate ET into their care revealed that multiple patient, provider, and system barriers limited the degree to which transplant education could be improved. Thus, a more comprehensive case-management program to educate patients through external organizations may be needed to supplement ongoing transplant education within dialysis centers. For this grant, the investigators propose to test the effectiveness of another replicable solution for disseminating ET education on a broad scale: Partnering with a large health insurance organization to deliver video-guided transplant education supported by telephone and mail. The Missouri Kidney Program (MoKP) is a state-wide organization whose mission is to serve and educate kidney patients, particularly those who are economically disadvantaged. Since MoKP subsidizes the costs of dialysis medication for low-income ESRD patients, they operate as an insurance company would with respect to their 1200-patient member group. With 900 dialysis patients currently being managed by the MoKP, the investigators will conduct an eight-month, group randomized controlled trial (GRCT) where 540 patients will be randomized to receive: (1) no additional education other than from their dialysis center; (2) a video-guided, four-part Explore Transplant (ET) program delivered via the internet or mail; or (3) a video-guided ET program with discussion facilitated by a telephone case manager.

Conditions

End Stage Renal Disease

Keywords

Educator-Guided; Patient-Guided; Standard of Care (Control)

Outcome Measures

Primary Outcomes (1)

• Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge

  Patients will be asked 17 true/false and 8 multiple choice questions to determine their level of knowledge regarding basic facts, advantages, risks and outcomes of DDKT and LDKT (e.g., "Patients older than 75 years can receive transplants"; "Compared to transplants from donors who have died, how long do transplants from living donors last?"). Scores for this scale are created by summing the number of correct answers given by the patient, creating a theoretical range of 0-25 with higher scores indicating more knowledge.

  9 months

Secondary Outcomes (2)

• Informed Decision-Making

  9 months

• Decisional Balance

  9 months

Study Arms (3)

Standard of Care (Control)

NO INTERVENTION

Patients randomized to the standard of care condition will not receive any educational materials from our program and will only participate in the survey portion of the investigation. Dialysis providers will be asked to continue their current practices throughout the study period without change. While Control patients will be free to ask additional questions or solicit more information from their dialysis educators at any point during the study period, no additional educational interventions will be added to what is currently being done.

Patient-Guided

EXPERIMENTAL

Over an 8-month period, patients in the Patient-Guided intervention condition will receive four educational modules and twelve transplant education postcards in the mail. Modules will be mailed once every other month and consist of an introductory letter, a transplant video, and printed resources. Transplant education postcard will be mailed every two weeks following the mailing of each module, for a total of three postcards over the course of 6-weeks.

Other: Patient-Guided

Educator-Guided

EXPERIMENTAL

Patients in the Educator-Guided intervention condition will receive the same intervention components as those in the Patient-Guided condition; however, the key difference in this condition is that Educator-Guided patients will also receive telephonic support from an experienced clinical social worker in the role of a Transplant Educator to maximally facilitate learning. Telephonic meetings with the Transplant Educator will occur after the mailing of each study module, for a total of four calls, each lasting 20-minutes, totaling 1 hour and 20 minutes. Finally, Patient-Guided and Educator-Guided patients will have the option of enrolling in an educational text messaging service designed to supplement the ET education they are receiving in the mail.

Other: Patient-Guided; Other: Educator-Guided

Interventions

Patient-Guided OTHER

The "Explore Transplant" education program was designed to increase patient informed decision-making and knowledge and is based on the theoretical tenets of the Transtheoretical Model of Behavior Change. The program helps patients think about what might motivate them to pursue transplant, addresses commonly held concerns about transplant and involving a living donor, and shares real-life transplant stories of donors and recipients. The ET materials were written for patients with low health literacy. Already developed for the "Explore Transplant" program are brochures, videos, and factsheets. ET at Home is an expansion of the ET program. Newly designed postcards and text messages have added to the list of transplant education resources for this program.

Also known as: Explore Transplant at Home

Educator-Guided; Patient-Guided

Educator-Guided OTHER

The Transplant Educator supports the Explore Transplant at Home materials by facilitating a conversation about the content of the materials. The role of the Educator is filled by an experienced dialysis healthcare provider who can support a patient as they learn about their treatment options. The program is split into a series of four modules and the Educator conversations are guided by a Transplant Educator Guide and Patient Tracking Tool. This tool is intended to provide direct talking points for the Educator and is also a place where the patients' responses, questions, or concerns can be documented.

Also known as: Transplant Educator

Educator-Guided

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18-74 years of age.
• Participant must self-identify as African American or White.
• Participant must currently be on dialysis.
• Participant must have a household income at or below 250% of the federal poverty level.
• Participant must be able to speak and read in English.

You may not qualify if:

• Participant has a visual and/or hearing impairment that would preclude him/her from watching and reading educational study material.
• Participant has had a previous kidney transplant
• Participant has previously been told that they are not a candidate for transplant.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Missouri Kidney Program: collaborator

Study Sites (1)

UCLA Transplant Research and Education Center

Los Angeles, California, 90024, United States

Location

Related Publications (2)

• Waterman AD, Peipert JD, McSorley AM, Goalby CJ, Beaumont JL, Peace L. Direct Delivery of Kidney Transplant Education to Black and Low-Income Patients Receiving Dialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Nov;74(5):640-649. doi: 10.1053/j.ajkd.2019.03.430. Epub 2019 Jun 19.

  PMID: 31227225 DERIVED

• Waterman AD, McSorley AM, Peipert JD, Goalby CJ, Peace LJ, Lutz PA, Thein JL. Explore Transplant at Home: a randomized control trial of an educational intervention to increase transplant knowledge for Black and White socioeconomically disadvantaged dialysis patients. BMC Nephrol. 2015 Aug 28;16:150. doi: 10.1186/s12882-015-0143-0.

  PMID: 26316264 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

• Amy D Waterman, PHD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Patient Engagement, Diversity, and Education

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)