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.
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
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease
- What is being tested?
- House Calls and Web-Based Patient-Centered Decision Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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).
- 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
- 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.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- 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 group | Role | What they receive |
|---|---|---|
| House Calls only | Experimental | 60-minute educational intervention in patient's home which will be delivered by a health educator. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2013
- Primary completion31 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Rodrigue, Beth Israel Deaconess Medical Center
- Investigators
- James R Rodrigue, PhD, Principal investigator, Beth Israel Deaconess Medical CenterDidier Mandelbrot, MD, Study chair, Beth Israel Deaconess Medical CenterMartha Pavlakis, MS, Study chair, Beth Israel Deaconess Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- House Calls and Web-based Decision Support: Improving Access to Live Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01786525
- Acronym / sponsor ID
- 2012P000332
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- Live Donor Kidney Transplantation, LDKT, African American, Disparity, Education, Patient Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2013
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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).
- 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
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| House Calls only | Experimental | Behavioral: House Calls60-minute educational intervention in patient's home which will be delivered by a health educator. |
| House Calls + Web-Based Decision Support | Active comparator | Behavioral: House Calls, Behavioral: Web-Based Patient-Centered Decision Support InterventionHome based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention. |
| Control | No intervention | –100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Awaiting combined kidney-liver transplant
- Awaiting simultaneous pancreas-kidney transplant
- Know or suspected cognitive impairment
- Prior participation in House Calls intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| House Calls60-minute home based educational intervention which will be administered by a health educator | Behavioural | House Calls + Web-Based Decision Support, House Calls only |
| Web-Based Patient-Centered Decision Support InterventionPatients 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 | Behavioural | House Calls + Web-Based Decision Support |
Primary outcome
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants
Time frame: 2 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Rodrigue, PhD principal investigator
Beth Israel Deaconess Medical Center
Didier Mandelbrot, MD study chair
Beth Israel Deaconess Medical Center
Martha Pavlakis, MS study chair
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
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.