COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial (CONNECT-AKI)
2026年5月29日 更新者：Northwell Health
CONNECT-AKI: COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury - A Pilot Randomized Controlled Trial
The goal of this clinical trial is to learn whether different ways of providing information and follow-up support after acute kidney injury, also called AKI, can improve care transitions for adults being discharged from the hospital. AKI is a sudden decrease in kidney function that can occur during a hospital stay.
The main questions this study aims to answer are:
- Does an AKI discharge summary template improve communication about AKI after hospital discharge?
- Does a chat-based educational messaging program improve patient understanding of AKI and support follow-up care after hospital discharge?
- Researchers will compare usual care, an AKI discharge summary template, a chat-based educational messaging program, and the combination of the discharge summary template plus chat-based messaging.
Researchers will compare four groups:
- Usual care
- An AKI discharge summary template
- A chat-based educational messaging program
- Both the AKI discharge summary template and the chat-based educational messaging program
Participants will complete questionnaires at the start of the study and about 4 weeks after hospital discharge. Participants will also receive a brief phone call about 3 months after discharge, and the research team will review their medical record for information about follow-up care, lab testing, emergency department visits, and hospital readmissions.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Acute kidney injury, also called AKI, is a common complication during hospitalization and is associated with increased risk of poor outcomes after discharge, including incomplete kidney recovery, medication-related safety concerns, emergency department visits, and hospital readmissions. Despite these risks, information about AKI and recommended follow-up care may not always be communicated clearly to patients or outpatient clinicians during the transition from hospital to home.
This pilot randomized clinical trial will evaluate the feasibility and preliminary effects of two care transition strategies for adults hospitalized with AKI. The strategies include an AKI discharge summary template designed to improve communication with outpatient clinicians, and a chat-based educational messaging program designed to provide patients with AKI-related information after discharge.
Participants will be assigned to one of four study groups: usual care, the AKI discharge summary template, the chat-based educational messaging program, or both the discharge summary template and chat-based messaging. The study will assess whether these strategies are feasible to deliver and acceptable to participants, and whether they improve patient knowledge, perceived preparedness, communication about AKI, and completion of recommended follow-up care after hospital discharge.
Participants will complete study questionnaires and allow the research team to review their medical records for information related to kidney function monitoring, follow-up care, emergency department visits, and hospital readmissions. The results of this pilot study will help inform the design of a larger future trial to improve care transitions for patients recovering from AKI.
研究の種類
介入
入学 (推定)
160
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jia Hwei Ng, MD, MSCE
- 電話番号：516-465-8200
- メール：jng10@northwell.edu
研究連絡先のバックアップ
- 名前：Farwa Batool, MPH
- メール：fbatool@northwell.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 18 years or older
- Hospitalized with Stage 2 or Stage 3 acute kidney injury
- Kidney function has not returned to baseline at the time of hospital discharge
- Able to communicate in English
- Able to provide informed consent
- Willing and able to participate in study procedures independently or with assistance from a patient-designated care partner
Exclusion Criteria:
- Acute kidney injury requiring ongoing dialysis at the time of hospital discharge
- End-stage kidney disease
- Kidney transplant recipient
- Currently pregnant
- Documented cognitive impairment that precludes informed consent
- Receiving hospice or comfort-focused end-of-life care
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Usual Care
Participants assigned to this group will receive usual hospital discharge care.
No additional study discharge summary template or chat-based educational messaging program will be provided as part of the intervention.
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実験的：AKI Discharge Summary Template
Participants in this group will receive usual hospital discharge care plus use of an AKI discharge summary template.
The template is designed to support communication of AKI-related information and recommended follow-up care during the transition from hospital to outpatient care.
|
The AKI discharge summary template provides structured AKI-related information for the hospital discharge summary, including information about the AKI episode and recommended follow-up care.
The template is intended to improve communication during the transition from hospital to outpatient care.
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実験的：Chat-Based Educational Messaging Program
Participants in this group will receive usual hospital discharge care plus access to a chat-based educational messaging program after hospital discharge.
The program provides plain-language AKI education and follow-up support through a secure web-based chat-style interface.
|
The chat-based educational messaging program provides AKI-related educational messages after hospital discharge.
Messages are delivered through a secure web-based chat-style interface and are designed to support patient understanding of AKI, post-discharge follow-up, and kidney-related care after hospitalization.
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実験的：AKI Discharge Summary Template + Chat-Based Educational Messaging Program
Participants in this group will receive usual hospital discharge care plus both study interventions: use of the AKI discharge summary template and access to the chat-based educational messaging program after hospital discharge.
|
The AKI discharge summary template provides structured AKI-related information for the hospital discharge summary, including information about the AKI episode and recommended follow-up care.
The template is intended to improve communication during the transition from hospital to outpatient care.
The chat-based educational messaging program provides AKI-related educational messages after hospital discharge.
Messages are delivered through a secure web-based chat-style interface and are designed to support patient understanding of AKI, post-discharge follow-up, and kidney-related care after hospitalization.
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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 |
|---|---|---|
|
Feasibility: Eligible patient enrollment
時間枠：Enrollment period
|
Percentage of eligible patients enrolled among those approached.
|
Enrollment period
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Feasibility: Participant retention
時間枠：Baseline to 3 months after discharge
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Percentage of enrolled participants who complete the follow-up assessment.
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Baseline to 3 months after discharge
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Feasibility: Successful delivery of assigned intervention components
時間枠：Hospital discharge through 4 weeks after discharge
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Percentage of participants assigned to an intervention arm who receive the assigned intervention component or components as intended, including the AKI discharge summary template and/or chat-based educational messaging program.
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Hospital discharge through 4 weeks after discharge
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AKI Knowledge Score
時間枠：4 weeks after hospital discharge
|
Participant AKI knowledge score measured using a study questionnaire.
|
4 weeks after hospital discharge
|
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Patient experience during care transitions
時間枠：4 weeks after hospital discharge
|
Patient-reported care transition experience measured using a validated transition-of-care instrument, such as the Care Transitions Measure-15.
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4 weeks after hospital discharge
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Self-management behaviors related to kidney health
時間枠：4 weeks after hospital discharge
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Participant-reported self-management behaviors related to kidney health after hospital discharge, assessed using a study questionnaire.
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4 weeks after hospital discharge
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Adherence to outpatient follow-up appointments
時間枠：4 weeks after hospital discharge, and 3 months after hospital discharge
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Percentage of participants who complete follow-up with a primary care provider or specialist after hospital discharge, assessed by participant report and/or medical record review.
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4 weeks after hospital discharge, and 3 months after hospital discharge
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Patient-reported discussion of AKI with outpatient provider
時間枠：4 weeks after hospital discharge
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Percentage of participants who report discussing AKI or kidney-related follow-up needs with an outpatient provider after hospital discharge.
|
4 weeks after hospital discharge
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital readmission
時間枠：Within 4 weeks and within 3 months after hospital discharge
|
Percentage of participants readmitted to the hospital after discharge from the index hospitalization.
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Within 4 weeks and within 3 months after hospital discharge
|
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Kidney function trajectory after discharge
時間枠：Within 4 weeks and within 3 months after hospital discharge
|
Kidney function status after hospital discharge, categorized as improved, stable, worsened, or requiring dialysis, based on available laboratory and clinical data.
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Within 4 weeks and within 3 months after hospital discharge
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jia Hwei Ng, MD, MSCE、Northwell Health
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2027年10月30日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年5月1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
- 26-0133
- K23DK132459 (米国 NIH グラント/契約)
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?
いいえ
IPD プランの説明
Individual participant data will not be shared at this time because this is a pilot feasibility study, and the dataset is expected to be small and potentially identifiable due to the clinical context, recruitment sites, hospitalization timing, and post-discharge care details.
Aggregate study results may be shared through presentations and publications.
The IPD sharing plan may be updated in the future if appropriate approvals, de-identification procedures, and data use agreements are established.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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