An interventional study of House Calls and Web-Based Patient-Centered Decision Support Intervention in Chronic Kidney Disease and End-Stage Renal Disease, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Health services research
The main purpose of this research program is to reduce the burden of end-stage organ disease on individuals, families, healthcare systems, and society by increasing the availability of donor organs for transplantation. Consistent with this aim, the project further examines strategies to increase access to and reduce disparities - racial, economic, gender - in live donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an innovative House Calls intervention developed by the principal investigator by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. The main study hypothesis is that participants receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have a higher proportion of LDKT's by the 2-year study endpoint.
For most adults in late Chronic Kidney Disease (CKD Stage 4 or 5), kidney transplantation yields superior outcomes compared to long-term dialysis. Unfortunately, the demand for kidney transplantation far exceeds the supply of deceased donor organs. For those patients with healthy and willing living kidney donors, live donor kidney transplantation (LDKT) produces superior graft and patient survival rates, lower acute rejection rates, more rapid improvements in functional status, and lower healthcare costs. However, there are profound racial and income disparities in access to LDKT. Minorities, especially Blacks and Hispanics, are substantially less likely to receive LDKT compared to Whites. Also, the overall decline in LDKTs in the United States in recent years has been more pronounced for Blacks and patients with less household income. These lower LDKT rates contribute to longer waiting times for transplantation, more dialysis exposure, higher likelihood of death before transplantation, declining functional capacity, less optimal graft outcomes after transplantation, and higher healthcare costs. Therefore, interventions that expand access to LDKT, especially those targeting minority and low-income populations, are needed given the current and projected shortage of deceased donor organs.
There are several hypothesized barriers to LDKT for minorities and low-income patients, including perceived discrimination, health care mistrust, social network differences, higher rates of conditions that preclude living kidney donation, higher indirect costs of living donation, less knowledge and more concerns about LDKT, and failure to provide culturally competent education to patients and their support systems. In the last decade, the PI has developed and evaluated an innovative House Calls intervention designed to remove LDKT barriers.28-30 Health educators deliver a comprehensive and interactive program on kidney transplantation and living donation in the patient's home with members of their social network present. Relative to standard clinic-based educational programs, the House Calls intervention is superior at improving LDKT knowledge, reducing LDKT concerns, increasing LDKT willingness, and increasing rates of LDKT, particularly in minority and low-income patients (see Preliminary Studies section). However, the effectiveness of the House Calls intervention may be limited by the absence of decision-making aids, exposure to appropriate peer models, and assistance in developing an LDKT action plan beyond the House Calls intervention. This limitation and feedback from study participants have informed our strategy to enhance the House Calls intervention by incorporating a Patient-Centered Decision Support component. Additionally, there is a pressing need to identify factors that are most critical to the success of the House Calls intervention and to determine whether it can reduce the gender disparity in living kidney donation.8 Therefore, in the proposed study, we plan to pursue two primary aims and one exploratory aim:
Primary Aims
Identify mediators of the relationship between the interventions and the occurrence of LDKT. We will investigate a set of mediators through which House Calls may increase the occurrence of LDKT, including increased LDKT knowledge, change in LDKT readiness, reduced LDKT concerns, reduced health care mistrust, the amount of time discussing LDKT with others and the quality of those interactions, and improvement in self-efficacy discussing LDKT with others.
Exploratory Aim
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This study's enrollment of 109 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
60-minute educational intervention in patient's home which will be delivered by a health educator.
Behavioral: House Calls
Home based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention.
Behavioral: House Calls · Behavioral: Web-Based Patient-Centered Decision Support Intervention
100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention
60-minute home based educational intervention which will be administered by a health educator
Patients will be provided with access to the study website which will allow them to learn and receive LDKT support in a way the best meets their personal values and preferences
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants
Time frame: 2 years
Higher proportion of enrolled patients with live donor inquires and evaluations; higher proportion of patients will be in LDKT Readiness stages 4/5 by the 12-week assessment.
Time frame: 2 years
Improvement in LDKT knowledge and LKDT readiness, reduced LDKT concerns and health care mistrust, greater amount of time spent discussing LDKT and higher quality interactions, and improvement in self-efficacy discussing LDKT.
Time frame: 12 weeks
Plan to share: No
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Beth Israel Deaconess Medical Center