Smart Discharges to Improve Post-discharge Health Outcomes in Children

February 14, 2023 updated by: Matthew Wiens, University of British Columbia

Smart Discharges to Improve Post-discharge Health Outcomes in Children: A Prospective Before-after Study With Staggered Implementation

In Uganda, about 5% of children discharged after hospitalization for a serious infection will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work to develop and evaluate models and technology to predict, before discharge, an individual child's risk of recurrent illness, as well as to provide additional post-discharge support to at-risk children. This study seeks to evaluate the effect of a novel "Smart Discharges" approach on childhood mortality and health seeking behaviour.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PURPOSE:

Our purpose is to conduct an interventional cohort study to evaluate the impact of the Smart Discharges approach to discharge care on pediatric post-discharge mortality.

HYPOTHESIS:

Our Smart Discharges approach will improve post-discharge health seeking and reduce post-discharge mortality.

JUSTIFICATION:

With an improved understanding of risk, and an ability to determine risk at the bedside, a Smart Discharge program will ensure optimized resource allocation, focusing on children most in need of limited resources. Such programs in precision public health can not only save lives and resources, but are much more likely to be scalable in economically strained environments.

OBJECTIVES:

The objective of this study is to determine whether a individualized, risk-based approach to improving pediatric discharges will reduce 6-month post-discharge mortality among children admitted with suspected sepsis

The study has two objectives, each corresponding to a phase:

  1. Phase I: An observational period with enrolled patients acting as controls. Furthermore, this cohort will be used to update, refine, and validate previously developed models for post-discharge mortality to be used during Phase II.
  2. Phase II: An interventional period to evaluate the effectiveness of a Smart Discharge program on mortality and post-discharge health seeking.

RESEARCH DESIGN:

This will be a two-phase study: Phase I is a multi-site prospective observational cohort study, while Phase II is a multi-site prospective interventional cohort study. This prospective study will be conducted from March 2017 to January 2024. The study will enroll 5700 children under five years of age (2700 <6 months of age, 3000 6-60m of age) in Phase I (non-interventional) and an equal number (5700) of children during phase II (interventional phase), for a total of 11,600 children.

STATISTICAL ANALYSIS:

Our prior work has shown that the 6-month post-discharge mortality rate is 5%. Our preliminary work has also suggested that our expected mortality benefit will be between 25% and 30% relative risk reduction. Assuming a relative risk reduction of 22.5%, we would need to enroll 5250 children per arm. We thus will conservatively aim to enroll 5700 per arm to account for losses to follow-up.

All analyses will be conducted using R 4.2.2 (Vienna, Austria; http://www.R-project.org). External model validation will be conducted using the Phase I cohort on the previously developed Smart Discharge Model. The Smart Discharge Model will then be updated to include data from the Phase I cohort. Final prediction models will be developed separately for children <6m of age and for children 6m - 5 years of age, with an area under the ROC curve analysis used to assess the overall performance of the final models. For the final model in older children (6m - 5y), the risk cut-off will be chosen based on the sensitivity and specificity, ensuring a sensitivity of >80% (initial derived model sensitivity was 82%). The final sensitivity and specificity will be reported, along with positive and negative predictive values (based on the overall mortality rate, and the mortality rates of each site). For the model in younger children, the same approach will be used, but ensuring the sensitivity is at least 85%, due to an expected higher mortality rate among younger children. The separation of ages has been determined to be the optimal approach for these models.

To evaluate the effectiveness of the intervention, a cox-proportional hazards regression on the time to post-discharge mortality will be used, including the year of discharge as a covariate to account for potential trends in mortality unrelated to the intervention. Additional potentially confounding variables will be identified based on a combination of pre-existing and expert knowledge, and univariate analysis of potential confounders on outcomes. A final multivariable model will be used to determine the adjusted effect of the Smart Discharge intervention. Interrupted time series, which use segmented regression modeling to determine the effect of the intervention after controlling for pre- and post-intervention time trends, will also be used to account for potential pre-intervention trends in mortality.

Study Type

Interventional

Enrollment (Anticipated)

11700

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 Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2X8
        • Recruiting
        • BC Children's Hospital Research Institute

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

1 second to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children under five years of age
  • Admission with a proven or suspected infection
  • Provide written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Previous enrolment in the study
  • Outside of hospital catchment
  • Language barrier
  • Direct admission following birth without having been discharged

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase 1: Observational, children 0-59 months of age
Phase 1: Observational only
Experimental: Phase 2: Interventional, children 0-59 months of age
Phase 2: Intervention
Behavioral: Risk-stratified discharge and post-discharge care

Interventional intensity is based on predicted risk. Predicted risk based on previously developed prediction algorithms.

Low risk: receive discharge education and counselling only; Moderate risk: Discharge education and counselling + 1 post-discharge follow-up referral at day 7; High risk: Discharge education and counselling + 3 post-discharge follow-up referrals (D2, D7, D14); Very high risk: Discharge education and counselling + 3 post-discharge follow-up referrals (D2, D7, D14, D28)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-discharge mortality
Time Frame: From discharge until 6 months post-discharge
Rate of all-cause mortality within 6-months post-discharge
From discharge until 6 months post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-discharge re-admission
Time Frame: From discharge until 6 months post-discharge
Rate of all-cause re-admissions within 6-months post-discharge.
From discharge until 6 months post-discharge
Post-discharge health seeking
Time Frame: From discharge until 6 months post-discharge

proportion of patients who reported attending a post-discharge referral visit within 6 months post-discharge.

proportion of patients who reported seeking any care within 6 months post-discharge through self referral.
From discharge until 6 months post-discharge

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Grand Challenges Canada
Mbarara University of Science and Technology
Thrasher Research Fund
British Columbia Childrens Hospital Foundation
Walimu

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 (Actual)

July 16, 2017

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-02679
  • F21-05597 (Other Grant/Funding Number: BC Children's Hospital Research Institute)
  • F17-02096 (Other Grant/Funding Number: Thrasher Research Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At each stage of the analysis and data preparation all of the study data will be prepared for public distribution. We will make every effort to prevent re-identification of subjects by coding data that has the potential of being identifiable. For example we will convert all dates into meaningful decimal numbers (date of birth into days since birth and date of recruitment will be reduced to month of recruitment) and all locations will coded into data that is useful but not specific (such as address converted to distance and direction from facility). We will ensure that data elements with small numbers of subjects (less than 10) will be coded or lumped to avoid identification. The study data will be made publically available using a reputable data hosting service (e.g. INDEPTH Data Repository, Dataverse etc.).

During the data analysis stage, data lacking patient identifiers will be accessed from REDCap by team members involved in the statistical analysis.

IPD Sharing Time Frame

Data will be deposited to an open access repository with moderated access within 2 years of study completion

IPD Sharing Access Criteria

Moderated access on a case-by-case basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Sepsis

Clinical Trials on Risk-stratified discharge and post-discharge care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe