조기 및 공평한 이식(STEPS) 연구를 달성하기 위한 시스템 개입
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27101
- Wake Forest University Health Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: STEPS 건강 시스템 감시 및 아웃리치 개입
|
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach |
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간섭 없음: 일반적인 신장 관리
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health system reported completion of transplant evaluation
기간: 18 months
|
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports |
18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Live donor inquires to transplant center
기간: 6 months, 12 months, 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 |
6 months, 12 months, 18 months
|
|
Live kidney donor transplants
기간: 6 months, 12 months, 18 months
|
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire |
6 months, 12 months, 18 months
|
|
Placement on deceased kidney donor waitlist
기간: 6 months, 12 months, 18 months
|
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS |
6 months, 12 months, 18 months
|
|
Deceased kidney donor transplants
기간: 6 months, 12 months, 18 months
|
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS |
6 months, 12 months, 18 months
|
|
Health system reported initiation of transplant evaluation
기간: 18 months
|
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports |
18 months
|
|
Patient reported physician discussions
기간: baseline, 6 months, 12 months, 18 months
|
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported family discussions
기간: baseline, 6 months, 12 months, 18 months
|
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported initiation of transplant evaluation
기간: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported completion of transplant evaluation
기간: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported identification of a living donor
기간: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported kidney transplant knowledge
기간: baseline, 6 months, 12 months, 18 months
|
Number of questions patients correctly answer measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported empowerment
기간: baseline, 6 months, 12 months, 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. |
baseline, 6 months, 12 months, 18 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Ebony Boulware, M.D., Wake Forest University Health Sciences
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00097407
- 7U01DK127918-02 (미국 NIH 보조금/계약)
- IHS-2020C1-19350-IC (기타 보조금/기금 번호: PCORI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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