Kidney Transplant WaitlistingINSPIRENCT06655857
Interventions for Promoting Kidney Transplant Empowerment
A study testing Community Health Worker Assistance and Intervention Providers in people with Kidney Transplant Waitlisting, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Waitlisting
- What is being tested?
- Community Health Worker Assistance and Intervention Providers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Aug 2025to 29 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient inclusion:
- Provision of signed and dated informed consent from the patient.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 18 - 75 years
- eGFR≤20 mL/min/1.73m2 or on maintenance in-center HD.
- Receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center.
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- Community dwelling (i.e., not in a nursing home, currently incarcerated).
- Speak English and/or Spanish.
- Provider Inclusion:
- Provision of signed and dated informed consent from the nephrologist.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Patient Exclusion:
- Absolute contraindications to KTx:
- Self-reported or documented diagnosis of dementia, or inability to understand the study and complete informed consent. When the participant's understanding is unclear, the CRC will use a modified MOCA screener to determine eligibility.
- Active malignancy (excluding local non-melanoma skin cancer, renal cell carcinoma <5 cm, early thyroid cancer, and prostate cancer GS≤6).
- Pregnancy (can be re-evaluated post-delivery).
- Active infection. Patients excluded due to active infection will be evaluated at 30 days or after completing full treatment (whichever is later) to determine eligibility. Examples of active infection include:
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- Positive cultures or radiographic evidence of infection
- Infected intravascular devices, such as tunneled catheters and pacemakers
- Active histoplasmosis, cryptococcosis, tuberculosis (TB), and nontuberculous mycobacteria
- Previously evaluated by KTx and not listed for specific medical reasons.
- Patients previously evaluated and not listed will be carefully reviewed by site PI for eligibility
- Already listed for KTx.
- Patients on other types of dialysis other than in-center hemodialysis.
- Self-identify as already engaged with a CHW at participating sites to address unmet social needs.
- Planning to move out of the greater NY area in the next 1 year.
- Provider Exclusion:
- Planning to leave their respective institutions in the next 1 year
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
NYU Langone Health
New York, New York, 10016
Michal Melamed, Michal.Melamed@nyulangone.org
Michal Melamed
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Lili Chan, lili.chan@mountsinai.org
Sabrina Clermont, sabrina.clermont@mountsinai.org
- Not yet recruiting
Montefiore Einstein
The Bronx, New York, 10467
Tanya Johns, tjohns@montefiore.org
Tanya Johns
About this study
This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).
- Conditions
- Kidney Transplant Waitlisting
- Being tested
- Usual Care, Community Health Worker Assistance, Intervention Providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Participants are provided care as usual. Clinicians (CKD, HD, KTx) will educate participants on the kidney transplant process. Clinician will receive the education intervention to provide participants at study end.
Community Health Worker AssistanceOther
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Intervention ProvidersOther
Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support | Other | Participants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services. Receives: Other: Community Health Worker Assistance; Other: Intervention Providers |
| Usual Care | Other | Participants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention. Receives: Other: Usual Care; Other: Community Health Worker Assistance; Other: Intervention Providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion of kidney transplant waitlisting evaluation
Patient medical records will be reviewed, and the patient will be asked directly for the status of their kidney transplant evaluation.
Measured: Baseline, and then every 6 months up to 2 years
Secondary outcomes (6)
Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
The AHC-HRSN is a 10-item screening tool designed to help providers identify patients' needs across five core domains: Housing Instability, Food Insecurity, Transportation Problems, Interpersonal Safety, and Utility Help needs. Each item is scored using a Yes/No response format. If a patient answers "Yes" to any of the items, they are considered to have screened positive for a safety need.
Measured: Baseline, and then every 6 months up to 2 years
Discrimination in Medical Settings (DMS)
The Discrimination in Medical Settings (DMS) Scale is a modified version of the EDS that has been previously used to study perceived discrimination in medical settings, among patients with a range of clinical conditions. Responses to each of the 7 items are assessed with a 5-point Likert scale. Scores range from 7-35. Higher scores indicate higher frequencies of experiences with everyday mistreatment.
Measured: Baseline, and 12 months after first study visit
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2
The Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health is a patient reported measure of physical, mental and social health. Items query general health, quality of life, physical health, mental health, satisfaction with discretionary social activities, carrying out every day physical activities, pain, fatigue, satisfaction with social roles, and emotional problems. For scoring, Item-levels are scored numerically for an individual's response to each question. Responses to each of the items are assessed with a 5-point Likert scale. Raw scores range from 7-35. Higher scores indicate higher presence of symptom.
Measured: Baseline, and 12 months after first study visit
Initiation of KTx process
Will measure whether or not the patient started the kidney transplant process. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly. A response of yes/no will be recorded.
Measured: Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment
Will measure whether or not the patient has been waitlisted for a kidney transplant at 1 year out from being enrolled in the trial. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly for confirmation. A response of yes/no will be recorded.
Measured: Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment
Will measure whether or not the patient has been waitlisted for a kidney transplant at 2 years out from being enrolled in the trial. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly for confirmation. A response of yes/no will be recorded.
Measured: Baseline, and then every 6 months up to 2 years after patients first study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start5 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion29 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant WaitlistingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Chan, Icahn School of Medicine at Mount Sinai
- Investigators
- Lili Chan, Principal investigator, Ichan School of Medicine at Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655857
- Sponsor's protocol ID
- GCO 22-1921
- Other IDs
- U01DK137259
- Acronym
- INSPIRE
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be deidentified for analysis
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Promoting Kidney Transplant Empowerment
- ClinicalTrials.gov ID
- NCT06655857
- Acronym / sponsor ID
- INSPIRE / GCO 22-1921
- Conditions
- Kidney Transplant Waitlisting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- 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.
This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support | Other | Other: Community Health Worker Assistance, Other: Intervention ProvidersParticipants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services. |
| Usual Care | Other | Other: Usual Care, Other: Community Health Worker Assistance, Other: Intervention ProvidersParticipants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient inclusion:
- Provider Inclusion:
Key exclusion criteria (17 listed)
- Patient Exclusion:
- Provider Exclusion:
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 |
|---|---|---|
| Usual CareParticipants are provided care as usual. Clinicians (CKD, HD, KTx) will educate participants on the kidney transplant process. Clinician will receive the education intervention to provide participants at study end. | Other | Usual Care |
| Community Health Worker AssistanceCommunity health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services | Other | Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support, Usual Care |
| Intervention ProvidersIntervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs). | Other | Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support, Usual Care |
Primary outcome
Time to completion of kidney transplant waitlisting evaluation
Time frame: Baseline, and then every 6 months up to 2 years
Patient medical records will be reviewed, and the patient will be asked directly for the status of their kidney transplant evaluation.
6 secondary outcomes
Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
Time frame: Baseline, and then every 6 months up to 2 years
Discrimination in Medical Settings (DMS)
Time frame: Baseline, and 12 months after first study visit
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2
Time frame: Baseline, and 12 months after first study visit
Initiation of KTx process
Time frame: Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment
Time frame: Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment
Time frame: Baseline, and then every 6 months up to 2 years after patients first study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. All data will be deidentified for analysis
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.
Lili Chan principal investigator
Ichan School of Medicine at Mount Sinai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Assistance and Intervention Providers in people with Kidney Transplant Waitlisting, run by Icahn School of Medicine at Mount Sinai at 3 sites 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Chan (929-618-0350, lili.chan@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to completion of kidney transplant waitlisting evaluation (time frame: Baseline, and then every 6 months up to 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 1 May 2026.