System Interventions to Achieve Early and Equitable Transplants (STEPS) Study

Study Overview
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Brief Summary
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This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.

Official Title
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System Interventions to Achieve Early and Equitable Transplants (STEPS) Study

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: STEPS Health System Outreach intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide oral informed consent Male or female, aged 18 to <=75 years Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10% English speaking with adequate ability to hear and understand questions over the phone Willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Male or female, aged <18 or > 75 years Non-English speaking Lack of ability to hear and comprehend verbal communication. Patients on dialysis Deceased Hospice/palliative care Prior kidney transplant Currently waitlisted at any transplant center Self-reported terminal illness or receipt of hospice services

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEPS Health System Surveillance and Outreach intervention<br> | Behavioral: STEPS Health System Outreach intervention<br>* STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach<br>|
| No Intervention: Usual Kidney Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health system reported completion of transplant evaluation | Number of patients that said yes to the completion of transplant evaluation as reported in health system EHR and Administrative reports | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live donor inquires to transplant center | the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire | 6 months | 
| Live donor inquires to transplant center | the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire | 12 months | 
| Live donor inquires to transplant center | the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire | 18 months | 
| Live kidney donor transplants | The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire | 6 months | 
| Live kidney donor transplants | The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire | 12 months | 
| Live kidney donor transplants | The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire | 18 months | 
| Placement on deceased kidney donor waitlist | The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS | 6 months | 
| Placement on deceased kidney donor waitlist | The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS | 12 months | 
| Placement on deceased kidney donor waitlist | The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS | 18 months | 
| Deceased kidney donor transplants | The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS | 6 months | 
| Deceased kidney donor transplants | The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS | 12 months | 
| Deceased kidney donor transplants | The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS | 18 months | 
| Health system reported initiation of transplant evaluation | Number of patients that said yes to the initiation of transplant evaluation as reported in health system EHR and Administrative reports | 18 months | 
| Patient reported physician discussions | number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire | baseline | 
| Patient reported physician discussions | number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire | 6 months | 
| Patient reported physician discussions | number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire | 12 months | 
| Patient reported physician discussions | number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire | 18 months | 
| Patient reported family discussions | number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire | baseline | 
| Patient reported family discussions | number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire | 6 months | 
| Patient reported family discussions | number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire | 12 months | 
| Patient reported family discussions | number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire | 18 months | 
| Patient reported initiation of transplant evaluation | Number of patients that said yes to the initiation of transplant evaluation measured by patient report in questionnaire | baseline | 
| Patient reported initiation of transplant evaluation | Number of patients that said yes to the initiation of transplant evaluation measured by patient report in questionnaire | 6 months | 
| Patient reported initiation of transplant evaluation | Number of patients that said yes to the initiation of transplant evaluation measured by patient report in questionnaire | 12 months | 
| Patient reported initiation of transplant evaluation | Number of patients that said yes to the initiation of transplant evaluation measured by patient report in questionnaire | 18 months | 
| Patient reported completion of transplant evaluation | Number of patients that said yes to the completion of transplant evaluation measured by patient report in questionnaire | baseline | 
| Patient reported completion of transplant evaluation | Number of patients that said yes to the completion of transplant evaluation measured by patient report in questionnaire | 6 months | 
| Patient reported completion of transplant evaluation | Number of patients that said yes to the completion of transplant evaluation measured by patient report in questionnaire | 12 months | 
| Patient reported completion of transplant evaluation | Number of patients that said yes to the completion of transplant evaluation measured by patient report in questionnaire | 18 months | 
| Patient reported identification of a living donor | Number of patients that said yes to the identification of a living donor measured by patient report in questionnaire | baseline | 
| Patient reported identification of a living donor | Number of patients that said yes to the identification of a living donor measured by patient report in questionnaire | 6 months | 
| Patient reported identification of a living donor | Number of patients that said yes to the identification of a living donor measured by patient report in questionnaire | 12 months | 
| Patient reported identification of a living donor | Number of patients that said yes to the identification of a living donor measured by patient report in questionnaire | 18 months | 
| Patient reported kidney transplant knowledge | Number of questions patients correctly answer measured by patient report in questionnaire | baseline | 
| Patient reported kidney transplant knowledge | Number of questions patients correctly answer measured by patient report in questionnaire | 6 months | 
| Patient reported kidney transplant knowledge | Number of questions patients correctly answer measured by patient report in questionnaire | 12 months | 
| Patient reported kidney transplant knowledge | Number of questions patients correctly answer measured by patient report in questionnaire | 18 months | 
| Patient reported empowerment | Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. | Baseline | 
| Patient reported empowerment | Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. | 6 months | 
| Patient reported empowerment | Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. | 12 months | 
| Patient reported empowerment | Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, Living donor kidney transplant