早期かつ公平な移植を達成するためのシステム介入（STEPS）研究
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27101
- Wake Forest University Health Sciences
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：STEPS 保健システムの監視とアウトリーチの介入
|
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach |
|
介入なし：いつもの腎臓ケア
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health system reported completion of transplant evaluation
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Live donor inquires to transplant center
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
協力者
捜査官
- 主任研究者：Ebony Boulware, M.D.、Wake Forest University Health Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00097407
- 7U01DK127918-02 (米国 NIH グラント/契約)
- IHS-2020C1-19350-IC (その他の助成金/資金番号：PCORI)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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