COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial (CONNECT-AKI)

May 29, 2026 updated by: 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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Eligible patient enrollment
Time Frame: Enrollment period
Percentage of eligible patients enrolled among those approached.
Enrollment period
Feasibility: Participant retention
Time Frame: Baseline to 3 months after discharge
Percentage of enrolled participants who complete the follow-up assessment.
Baseline to 3 months after discharge
Feasibility: Successful delivery of assigned intervention components
Time Frame: Hospital discharge through 4 weeks after discharge
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.
Hospital discharge through 4 weeks after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI Knowledge Score
Time Frame: 4 weeks after hospital discharge
Participant AKI knowledge score measured using a study questionnaire.
4 weeks after hospital discharge
Patient experience during care transitions
Time Frame: 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.
4 weeks after hospital discharge
Self-management behaviors related to kidney health
Time Frame: 4 weeks after hospital discharge
Participant-reported self-management behaviors related to kidney health after hospital discharge, assessed using a study questionnaire.
4 weeks after hospital discharge
Adherence to outpatient follow-up appointments
Time Frame: 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
Patient-reported discussion of AKI with outpatient provider
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital readmission
Time Frame: Within 4 weeks and within 3 months after hospital discharge
Percentage of participants readmitted to the hospital after discharge from the index hospitalization.
Within 4 weeks and within 3 months after hospital discharge
Kidney function trajectory after discharge
Time Frame: 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.
Within 4 weeks and within 3 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jia Hwei Ng, MD, MSCE, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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