System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: STEPS Health System Outreach intervention
- Registration Number
- NCT05014256
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STEPS Health System Surveillance and Outreach intervention STEPS Health System Outreach intervention -
- Primary Outcome Measures
Name Time Method Health system reported completion of transplant evaluation 18 months Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports
- Secondary Outcome Measures
Name Time Method Patient reported initiation of transplant evaluation 18 months Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient reported identification of a living donor 18 months Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Placement on deceased kidney donor waitlist 18 months The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
Patient reported kidney transplant knowledge 18 months Number of questions patients correctly answer measured by patient report in questionnaire
Live donor inquires to transplant center 18 months the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire
Deceased kidney donor transplants 18 months The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Patient reported family discussions 18 months number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient reported empowerment 18 months 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.
Live kidney donor transplants 18 months The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Health system reported initiation of transplant evaluation 18 months Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports
Patient reported physician discussions 18 months number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient reported completion of transplant evaluation 18 months Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States