COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial (CONNECT-AKI)
2026년 5월 29일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
160
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jia Hwei Ng, MD, MSCE
- 전화번호: 516-465-8200
- 이메일: jng10@northwell.edu
연구 연락처 백업
- 이름: Farwa Batool, MPH
- 이메일: fbatool@northwell.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 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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실험적: 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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실험적: 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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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility: Eligible patient enrollment
기간: Enrollment period
|
Percentage of eligible patients enrolled among those approached.
|
Enrollment period
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Feasibility: Participant retention
기간: Baseline to 3 months after discharge
|
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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
AKI Knowledge Score
기간: 4 weeks after hospital discharge
|
Participant AKI knowledge score measured using a study questionnaire.
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4 weeks after hospital discharge
|
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Patient experience during care transitions
기간: 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
기간: 4 weeks after hospital discharge
|
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
기간: 4 weeks after hospital discharge, and 3 months after hospital discharge
|
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.
|
4 weeks after hospital discharge, and 3 months after hospital discharge
|
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Patient-reported discussion of AKI with outpatient provider
기간: 4 weeks after hospital discharge
|
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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospital readmission
기간: 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
기간: Within 4 weeks and within 3 months after hospital discharge
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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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Jia Hwei Ng, MD, MSCE, Northwell Health
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2027년 10월 30일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26-0133
- K23DK132459 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .