Explore Transplant at Home: Improving Low-Income ESRD Patients' Transplant Knowledge
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

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.
    

Detailed description: 
      Nationwide, there are almost 600,000 patients with end-stage renal disease (ESRD), or kidney
      failure. There are two options for ESRD patients to sustain life: dialysis, where a machine
      filters wastes from the blood, or a kidney transplant from a deceased or living donor. Kidney
      transplantation, especially living donor kidney transplant (LDKT), offers ESRD patients 3 to
      17 additional years of life and improved quality-of-life compared to remaining on dialysis.

      However, the majority of ESRD patients- 415,000 as of 2009 - still remain on dialysis.
      Although dialysis is life-saving, it only replaces 10-15% of normal kidney function and can
      lead to cardiovascular disease, infection, and other complications. Dialysis treatment also
      takes 12 to 15 hours per week, requiring many patients to stop work and go on disability. The
      chance of a dialysis patient being alive after 5 years without a transplant is only 38%.

      A complex set of potential risks and benefits need to be considered when deciding whether to
      get an LDKT, particularly for low-income dialysis patients facing significant practical and
      financial barriers to transplant. Established chronic kidney disease (CKD) and Centers for
      Medicaid and Medicare Services (CMS) guidelines recommend that dialysis patients be educated
      about their different treatment options, the medical risks involved, and the advantages to
      transplant so that they can make informed transplant decisions. Since transplants within the
      first six months of beginning dialysis result in the best health outcomes, one Healthy People
      2020 proposed goal is to, "Increase the proportion of dialysis patients wait-listed and/or
      receiving a deceased donor kidney transplant within one year of ESRD start (among patients
      under 70 years of age)". Unfortunately, research has shown that many patients in dialysis
      centers are inconsistently educated about LDKT, particularly patients who are
      socioeconomically disadvantaged or members of racial/ethnic minority groups.

      Through a previous HRSA grant, Dr. Waterman designed the Explore Transplant (ET) education
      program based on Prochaska's Transtheoretical Model of Behavioral Change and her own research
      with over 1000 patients with kidney disease to address key gaps in patients' transplant
      knowledge. The mission of ET is for transplant-eligible patients to explore the option of
      transplant and make an informed choice after knowing the benefits and risks. Through a group
      randomized controlled trial (GRCT), an earlier version of ET, delivered face-to-face with
      patients while they were undergoing dialysis, was shown to increase patients' knowledge and
      informed decision-making. As a result, the Explore Transplant program won the 2009 National
      Association of Transplant Professionals (NATCO) Quality of Care Award. However, additional
      research exploring dialysis providers' ability to integrate ET in their patient care found
      that multiple patient, provider, and system barriers limited what can be accomplished
      educationally within dialysis centers. With dialysis providers reporting that they have
      limited time to educate patients, a more comprehensive case-management program through
      external organizations may be needed to supplement the inconsistent transplant education
      provided within dialysis centers.

      Thus, for this grant, the investigators propose to test the effectiveness of another
      replicable and transferable solution for disseminating ET transplant education nationally for
      patients in chronic kidney disease (CKD) Stages 3-5: Partnering with a large health insurance
      organization to provide transplant education supported by telephone and mail. The important
      research question now requiring study is whether this dissemination strategy also can promote
      greater transplant knowledge for patients, particularly for the most vulnerable patients
      least likely to receive comprehensive transplant education from dialysis centers.

      For this grant, the investigators have chosen to re-partner with an organization with which
      the investigators have had previous success conducting transplant education trials, the
      Missouri Kidney Program (MoKP). Since MoKP subsidizes the costs of dialysis and transplant
      medication for low-income ESRD patients in Missouri, they operate as an insurance company
      would with respect to their 1200-patient member group. MoKP is also a natural ally for
      underserved groups of kidney patients and can focus on educating them comprehensively about
      DDKT and LDKT without other competing job responsibilities. Finally, they have strong,
      statewide partnerships with every dialysis center in Missouri, with permission to communicate
      with social workers about the needs, transplant education needs and care of specific dialysis
      patients.

      Therefore, in partnership with the MoKP, this grant team will conduct a group randomized
      controlled trial (GRCT) of 540 low-income dialysis patients in order to assess how an
      established, video-guided transplant education program, Explore Transplant, could be
      incorporated within a centralized health care organization's delivery of transplant
      education. The investigators will conduct an eight-month educational intervention where
      patients will be randomized to receive: (1) no additional education other than what is
      provided within the dialysis center; (2) a video-guided, four-part ET program delivered via
      the internet or mail; or (3) a video-guided, four-part ET program with discussion facilitated
      by a Transplant Educator via telephone. The investigators expect 20% attrition over time for
      a final sample of 430 Black and White patients. The investigators will also conduct
      considerable formative work to assess the unique difficulties faced by Black and White
      low-income patients in learning about transplant online and by telephone.

      The grant aims are:

      Aim 1: To understand the transplant educational needs and barriers to learning faced by
      low-income Black and White ESRD patients.

      Aim 2: Compared to standard-of-care dialysis center education, to conduct a GRCT to assess
      the effectiveness of patient-guided and case-manager-guided ET education on improving
      low-income patients' DDKT and LDKT knowledge and informed LDKT decision-making.

      Aim 3: To examine how patient characteristics and the quality of their dialysis center
      transplant education act alone and in combination with the ET educational programs
    

Intervention name(s): Patient-Guided; Educator-Guided
Intervention type(s): Other; Other
Intervention description(s): 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.; 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 intervention name(s): Explore Transplant at Home; Transplant Educator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Educator-Guided; Patient-Guided; Standard of Care (Control)