House Calls and Decision Support: Improving Access to Live Donor Transplantation

NCT01786525 | Completed

• 2 other identifiers: 2012P000332R01DK098727
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease; End-Stage Renal Disease

Keywords

Live Donor Kidney Transplantation; LDKT; African American; Disparity; Education; Patient Support

Outcome Measures

Primary Outcomes (1)

• The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Other Outcomes (1)

• 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.

  12 weeks

Study Arms (3)

House Calls only

EXPERIMENTAL

60-minute educational intervention in patient's home which will be delivered by a health educator.

Behavioral: House Calls

House Calls + Web-Based Decision Support

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention

Interventions

House Calls BEHAVIORAL

60-minute home based educational intervention which will be administered by a health educator

House Calls + Web-Based Decision Support; House Calls only

Web-Based Patient-Centered Decision Support Intervention BEHAVIORAL

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

House Calls + Web-Based Decision Support

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-White race/Hispanic ethnicity/low-income (250% below federal poverty guidelines)
• CKD/ESRD
• meets eligibility criteria for kidney transplant waiting list
• years old or older
• self-reports being in LDKT Readiness Stage I, II, or III
• Resides within 3 hours driving time from transplant center

You may not qualify if:

• Awaiting combined kidney-liver transplant
• Awaiting simultaneous pancreas-kidney transplant
• Know or suspected cognitive impairment
• Prior participation in House Calls intervention study

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

House Calls

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• James R Rodrigue, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Didier Mandelbrot, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• Martha Pavlakis, MS

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: June 1, 2013
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)