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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05014256
• Other study ID #: IRB00097407
• Secondary ID: U01DK127918-01IH
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1168
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• STEPS Health System Outreach intervention
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Geisinger Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwell Health, Patient-Centered Outcomes Research Institute, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Live kidney donor transplants	The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire	6 months
Secondary	Live kidney donor transplants	The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire	12 months
Secondary	Live kidney donor transplants	The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Deceased kidney donor transplants	The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS	6 months
Secondary	Deceased kidney donor transplants	The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS	12 months
Secondary	Deceased kidney donor transplants	The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS	18 months
Secondary	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
Secondary	Patient reported physician discussions	number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire	baseline
Secondary	Patient reported physician discussions	number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire	6 months
Secondary	Patient reported physician discussions	number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire	12 months
Secondary	Patient reported physician discussions	number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire	18 months
Secondary	Patient reported family discussions	number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire	baseline
Secondary	Patient reported family discussions	number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire	6 months
Secondary	Patient reported family discussions	number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire	12 months
Secondary	Patient reported family discussions	number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient reported kidney transplant knowledge	Number of questions patients correctly answer measured by patient report in questionnaire	baseline
Secondary	Patient reported kidney transplant knowledge	Number of questions patients correctly answer measured by patient report in questionnaire	6 months
Secondary	Patient reported kidney transplant knowledge	Number of questions patients correctly answer measured by patient report in questionnaire	12 months
Secondary	Patient reported kidney transplant knowledge	Number of questions patients correctly answer measured by patient report in questionnaire	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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