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

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05014256
Collaborator
Northwell Health (Other), Geisinger Clinic (Other), University of Mississippi Medical Center (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Patient-Centered Outcomes Research Institute (Other)
1,150
1
2
29
39.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STEPS Health System Outreach intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Actual Study Start Date :
Apr 2, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: STEPS Health System Surveillance and Outreach intervention

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

No Intervention: Usual Kidney Care

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Live donor inquires to transplant center [6 months]

    the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire

  2. Live donor inquires to transplant center [12 months]

    the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire

  3. 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

  4. Live kidney donor transplants [6 months]

    The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire

  5. Live kidney donor transplants [12 months]

    The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire

  6. Live kidney donor transplants [18 months]

    The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire

  7. Placement on deceased kidney donor waitlist [6 months]

    The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS

  8. Placement on deceased kidney donor waitlist [12 months]

    The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS

  9. 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

  10. Deceased kidney donor transplants [6 months]

    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

  11. Deceased kidney donor transplants [12 months]

    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

  12. Deceased kidney donor transplants [18 months]

    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

  13. 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

  14. Patient reported physician discussions [baseline]

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  15. Patient reported physician discussions [6 months]

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  16. Patient reported physician discussions [12 months]

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  17. Patient reported physician discussions [18 months]

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  18. Patient reported family discussions [baseline]

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  19. Patient reported family discussions [6 months]

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  20. Patient reported family discussions [12 months]

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  21. Patient reported family discussions [18 months]

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  22. Patient reported initiation of transplant evaluation [baseline]

    Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire

  23. Patient reported initiation of transplant evaluation [6 months]

    Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire

  24. Patient reported initiation of transplant evaluation [12 months]

    Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire

  25. 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

  26. Patient reported completion of transplant evaluation [baseline]

    Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

  27. Patient reported completion of transplant evaluation [6 months]

    Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

  28. Patient reported completion of transplant evaluation [12 months]

    Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

  29. 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

  30. Patient reported identification of a living donor [baseline]

    Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire

  31. Patient reported identification of a living donor [6 months]

    Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire

  32. Patient reported identification of a living donor [12 months]

    Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire

  33. 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

  34. Patient reported kidney transplant knowledge [baseline]

    Number of questions patients correctly answer measured by patient report in questionnaire

  35. Patient reported kidney transplant knowledge [6 months]

    Number of questions patients correctly answer measured by patient report in questionnaire

  36. Patient reported kidney transplant knowledge [12 months]

    Number of questions patients correctly answer measured by patient report in questionnaire

  37. Patient reported kidney transplant knowledge [18 months]

    Number of questions patients correctly answer measured by patient report in questionnaire

  38. Patient reported empowerment [Baseline]

    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.

  39. Patient reported empowerment [6 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.

  40. Patient reported empowerment [12 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.

  41. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27701

Sponsors and Collaborators

  • Duke University
  • Northwell Health
  • Geisinger Clinic
  • University of Mississippi Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Ebony Boulware, M.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05014256
Other Study ID Numbers:
  • Pro00106720
  • U01DK127918-01
  • IHS-2020C1-19350
First Posted:
Aug 20, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022