This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014256
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : February 29, 2024
Sponsor:
Collaborators:
Northwell Health
Geisinger Clinic
University of Mississippi Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Chronic Kidney Diseases Behavioral: STEPS Health System Outreach intervention Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Health system reported completion of transplant evaluation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

  11. Deceased kidney donor transplants [ Time Frame: 12 months ]
    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

  12. Deceased kidney donor transplants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline ]
    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  15. Patient reported physician discussions [ Time Frame: 6 months ]
    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  16. Patient reported physician discussions [ Time Frame: 12 months ]
    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  17. Patient reported physician discussions [ Time Frame: 18 months ]
    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

  18. Patient reported family discussions [ Time Frame: baseline ]
    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  19. Patient reported family discussions [ Time Frame: 6 months ]
    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  20. Patient reported family discussions [ Time Frame: 12 months ]
    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

  21. Patient reported family discussions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline ]
    Number of questions patients correctly answer measured by patient report in questionnaire

  35. Patient reported kidney transplant knowledge [ Time Frame: 6 months ]
    Number of questions patients correctly answer measured by patient report in questionnaire

  36. Patient reported kidney transplant knowledge [ Time Frame: 12 months ]
    Number of questions patients correctly answer measured by patient report in questionnaire

  37. Patient reported kidney transplant knowledge [ Time Frame: 18 months ]
    Number of questions patients correctly answer measured by patient report in questionnaire

  38. Patient reported empowerment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014256


Contacts
Layout table for location contacts
Contact: Tara Strigo 919-668-4536 tara.strigo@duke.edu
Contact: Cassandra Bowman cassandra.bowman@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27701
Contact: Tara Strigo    336-516-1022    tara.strigo@duke.edu   
Contact: Clarissa Diamantidis       clarissa.diamantidis@duke.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
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
Layout table for investigator information
Principal Investigator: Ebony Boulware, M.D. Duke University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT05014256    
Other Study ID Numbers: IRB00097407
U01DK127918-01 ( U.S. NIH Grant/Contract )
IHS-2020C1-19350 ( Other Grant/Funding Number: PCORI )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: February 29, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Kidney transplant
Living donor kidney transplant
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes