Brief 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). 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).
Brief Title
Interventions for Promoting Kidney Transplant Equity
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
929-618-0350
Central Contact Email
lili.chan@mountsinai.org
Completion Date
Completion Date Type
Estimated
Conditions
Kidney Transplant Waitlisting
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT06655857
Org Class
Other
Org Full Name
Icahn School of Medicine at Mount Sinai
Org Study Id
GCO 22-1921
Overall Status
Not yet recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Interventions for Promoting Kidney Transplant Equity
Primary Outcomes
Outcome Description
Patient medical records will be reviewed, and the patient will be asked directly for the status of their kidney transplant evaluation.
Outcome Measure
Time to completion of kidney transplant waitlisting evaluation
Outcome Time Frame
Baseline, and then every 6 months up to 2 years
Secondary Ids
Secondary Id
U01DK137259
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline, and then every 6 months up to 2 years
Outcome Measure
Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
Outcome Description
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.
Outcome Time Frame
Baseline, and 12 months after first study visit
Outcome Measure
Discrimination in Medical Settings (DMS)
Outcome Description
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.
Outcome Time Frame
Baseline, and 12 months after first study visit
Outcome Measure
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2
Outcome Description
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.
Outcome Time Frame
Baseline, and 12 months after first study visit
Outcome Measure
Initiation of KTx process
Outcome Description
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.
Outcome Time Frame
Baseline, and 12 months after first study visit
Outcome Measure
Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment
Outcome Description
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.
Outcome Time Frame
Baseline, and then every 6 months up to 2 years after patients first study visit
Outcome Measure
Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tanya Johns
Investigator Email
tjohns@montefiore.org
Investigator Phone
718-430-8913