AzTrials
AzTrials

Chronic Kidney DiseaseNCT01786525

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

A study testing House Calls and Web-Based Patient-Centered Decision Support Intervention in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
House Calls and Web-Based Patient-Centered Decision Support Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteUnited States
Study dates
Jun 2013to 31 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: House Calls and Web-based Decision Support: Improving Access to Live Donor Kidney Transplantation

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.

Read the detailed description

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

  1. Evaluate the differential benefit of adding a patient-centered decision support component to the House Calls intervention. In a randomized controlled trial, we will compare House Calls (HC) alone to House Calls + Decision Support (HC+DS) in a sample of minorities and low-income patients. It is hypothesized that, compared to HC alone, the HC+DS group will have a higher proportion of patients with LDKT by the 2-yr study endpoint (primary outcome) and higher proportions of patients with ≥1 live donor inquiry, ≥1 live donor evaluation, and in LDKT Readiness Stages 4/5 by the 12-wk assessment (secondary outcomes).
  2. 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
  3. Examine whether the House Calls intervention reduces the gender disparity in rates of living kidney donation. Women comprise 60% of all living kidney donors in the past decade. We have shown that the House Calls intervention directly educates significantly more potential living donors, including men, compared to standard clinic-based educational approaches. We hypothesize that a higher proportion of patients receiving the House Calls intervention (either HC alone or HC+DS) will have at least one potential male donor evaluated and be more likely to receive a LDKT from a male living donor, relative to a non-intervention control group, controlling for patient race/ethnicity, gender, age, and household income.
Being tested
House Calls, Web-Based Patient-Centered Decision Support Intervention
Keywords
Live Donor Kidney Transplantation, LDKT, African American, Disparity, Education, Patient Support
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • House CallsBehavioural

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

  • Web-Based Patient-Centered Decision Support InterventionBehavioural

    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

Study groups in NCT01786525
Study groupRoleWhat they receive
House Calls onlyExperimental60-minute educational intervention in patient's home which will be delivered by a health educator.
Receives: Behavioral: House Calls
House Calls + Web-Based Decision SupportActive comparatorHome based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention.
Receives: Behavioral: House Calls; Behavioral: Web-Based Patient-Centered Decision Support Intervention
ControlNo intervention100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (1)
  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion31 May 2019
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01786525
Sponsor's protocol ID
2012P000332
Other IDs
R01DK098727
Status last verified
Jul 2020
First submitted
6 Feb 2013
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing House Calls and Web-Based Patient-Centered Decision Support Intervention in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in