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NCT Number: NCT06655857

Interventions for Promoting Kidney Transplant Empowerment

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).

Recruiting

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Key information

Conditions

Kidney Transplant Waitlisting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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:
  • 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

Treatment and study plan

Usual Care

Other

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 Assistance

Other

Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services

Intervention Providers

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)

    Time frame: Baseline, and then every 6 months up to 2 years

    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.

  2. Discrimination in Medical Settings (DMS)

    Time frame: Baseline, and 12 months after first study visit

    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.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2

    Time frame: Baseline, and 12 months after first study visit

    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.

  4. Initiation of KTx process

    Time frame: Baseline, and 12 months after first study visit

    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.

  5. Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment

    Time frame: Baseline, and 12 months after first study visit

    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.

  6. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lili Chan

CONTACT

[email protected]

929-618-0350

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: INSPIRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.