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

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ClinicalTrials.gov Identifier: NCT02268682
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Missouri Kidney Program
Information provided by (Responsible Party):
Amy D. Waterman, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: Patient-Guided Other: Educator-Guided Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Low-Income End Stage Renal Disease Patients' Transplant Knowledge: A Case Management Trial
Study Start Date : July 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care (Control)
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.
Experimental: Patient-Guided
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
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.
Other Name: Explore Transplant at Home

Experimental: Educator-Guided
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
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.
Other Name: Explore Transplant at Home

Other: Educator-Guided
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.
Other Name: Transplant Educator




Primary Outcome Measures :
  1. Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge [ Time Frame: 9 months ]
    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.


Secondary Outcome Measures :
  1. Informed Decision-Making [ Time Frame: 9 months ]

    Informed Decision-Making will be assessed in two ways. First, patients will be asked the following three questions: "I have all the facts I need to make an informed decision about whether to pursue DDKT/LKDT/remain on dialysis" (agree/disagree). Each of these questions will be treated as individual items and analyzed separately as outcomes.

    We will also use a validated measure of decisional conflict, the Decisional Conflict Scale (DCS). This scale assesses factors contributing to patients' uncertainty in making health-related decisions, and patients' assessment of their perceived effective decision-making. Each of these dimensions of decisional conflict will be considered as subscales, and together they will be considered as a total decisional conflict measure. The entire scale has 16 items (3 for decision uncertainty, 9 for factors contributing to uncertainty, and 4 for effective decision-making), each measured on a scale of (1) strongly agree to (5) strongly disagree. Total scale


  2. Decisional Balance [ Time Frame: 9 months ]
    Decisional Balance will be measured for DDKT (DB-DDKT) and for LDKT (DB-LDKT). DB-DDKT, a measure of a patient's perception of the benefits and disadvantages of deceased donor kidney transplant. This measure has been validated in a sample of dialysis patients84. Both measures contain two subscales, Pros and Cons of 6 items, wherein patients rate the importance of a specific Pro or Con to their DDKT or LDKT decision-making (e.g., "I would not have to be on dialysis") on a Likert-type scale from (1) "Not important" to (5) "Extremely important". Scores for the subscales will be obtained by summing the patients' responses to the items, implying a theoretical range of 6-30, with higher scores indicating more Pros or Cons, depending on the subscale. The DB-LDKT was also recently validated in a sample of dialysis patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must meet the following inclusion criteria to be enrolled:

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

Exclusion Criteria:

Subjects that meet any of the following exclusion criteria are not to be enrolled:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268682


Locations
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United States, California
UCLA Transplant Research and Education Center
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Missouri Kidney Program
Investigators
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Principal Investigator: Amy D Waterman, PHD University of California, Los Angeles

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy D. Waterman, Associate Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02268682     History of Changes
Other Study ID Numbers: R39OT26843
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amy D. Waterman, University of California, Los Angeles:
Educator-Guided
Patient-Guided
Standard of Care (Control)

Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency