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

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPS Health System Outreach intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring Kidney transplant, Living donor kidney transplant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEPS Health System Surveillance and Outreach intervention

Usual Kidney Care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Live kidney donor transplants
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Live kidney donor transplants
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Live kidney donor transplants
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
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
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
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
Deceased kidney donor transplants
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Deceased kidney donor transplants
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Deceased kidney donor transplants
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
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
Patient reported physician discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient reported physician discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient reported physician discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient reported physician discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient reported family discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient reported family discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient reported family discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient reported family discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Patient reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Patient reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Patient reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
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
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
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
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
Patient reported kidney transplant knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
Patient reported kidney transplant knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
Patient reported kidney transplant knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
Patient reported kidney transplant knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
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.
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.
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.
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.

Full Information

First Posted
August 13, 2021
Last Updated
April 13, 2023
Sponsor
Duke University
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
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1. Study Identification

Unique Protocol Identification Number
NCT05014256
Brief Title
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Official Title
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Kidney transplant, Living donor kidney transplant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEPS Health System Surveillance and Outreach intervention
Arm Type
Experimental
Arm Title
Usual Kidney Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
STEPS Health System Outreach intervention
Intervention Description
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach
Primary Outcome Measure Information:
Title
Health system reported completion of transplant evaluation
Description
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Live donor inquires to transplant center
Description
the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire
Time Frame
6 months
Title
Live donor inquires to transplant center
Description
the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire
Time Frame
12 months
Title
Live donor inquires to transplant center
Description
the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire
Time Frame
18 months
Title
Live kidney donor transplants
Description
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Time Frame
6 months
Title
Live kidney donor transplants
Description
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Time Frame
12 months
Title
Live kidney donor transplants
Description
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Time Frame
18 months
Title
Placement on deceased kidney donor waitlist
Description
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
Time Frame
6 months
Title
Placement on deceased kidney donor waitlist
Description
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
Time Frame
12 months
Title
Placement on deceased kidney donor waitlist
Description
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
Time Frame
18 months
Title
Deceased kidney donor transplants
Description
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Time Frame
6 months
Title
Deceased kidney donor transplants
Description
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Time Frame
12 months
Title
Deceased kidney donor transplants
Description
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Time Frame
18 months
Title
Health system reported initiation of transplant evaluation
Description
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports
Time Frame
18 months
Title
Patient reported physician discussions
Description
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Time Frame
baseline
Title
Patient reported physician discussions
Description
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Time Frame
6 months
Title
Patient reported physician discussions
Description
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Time Frame
12 months
Title
Patient reported physician discussions
Description
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Time Frame
18 months
Title
Patient reported family discussions
Description
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Time Frame
baseline
Title
Patient reported family discussions
Description
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Time Frame
6 months
Title
Patient reported family discussions
Description
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Time Frame
12 months
Title
Patient reported family discussions
Description
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Time Frame
18 months
Title
Patient reported initiation of transplant evaluation
Description
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Time Frame
baseline
Title
Patient reported initiation of transplant evaluation
Description
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Time Frame
6 months
Title
Patient reported initiation of transplant evaluation
Description
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Time Frame
12 months
Title
Patient reported initiation of transplant evaluation
Description
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Time Frame
18 months
Title
Patient reported completion of transplant evaluation
Description
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Time Frame
baseline
Title
Patient reported completion of transplant evaluation
Description
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Time Frame
6 months
Title
Patient reported completion of transplant evaluation
Description
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Time Frame
12 months
Title
Patient reported completion of transplant evaluation
Description
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Time Frame
18 months
Title
Patient reported identification of a living donor
Description
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Time Frame
baseline
Title
Patient reported identification of a living donor
Description
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Time Frame
6 months
Title
Patient reported identification of a living donor
Description
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Time Frame
12 months
Title
Patient reported identification of a living donor
Description
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Time Frame
18 months
Title
Patient reported kidney transplant knowledge
Description
Number of questions patients correctly answer measured by patient report in questionnaire
Time Frame
baseline
Title
Patient reported kidney transplant knowledge
Description
Number of questions patients correctly answer measured by patient report in questionnaire
Time Frame
6 months
Title
Patient reported kidney transplant knowledge
Description
Number of questions patients correctly answer measured by patient report in questionnaire
Time Frame
12 months
Title
Patient reported kidney transplant knowledge
Description
Number of questions patients correctly answer measured by patient report in questionnaire
Time Frame
18 months
Title
Patient reported empowerment
Description
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.
Time Frame
Baseline
Title
Patient reported empowerment
Description
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.
Time Frame
6 months
Title
Patient reported empowerment
Description
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.
Time Frame
12 months
Title
Patient reported empowerment
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Strigo
Phone
919-668-4536
Email
tara.strigo@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra Bowman
Email
cassandra.bowman@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebony Boulware, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Strigo
Phone
336-516-1022
Email
tara.strigo@duke.edu
First Name & Middle Initial & Last Name & Degree
Clarissa Diamantidis
Email
clarissa.diamantidis@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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