SepsisNCT05730452
Smart Discharges to Improve Post-discharge Health Outcomes in Children
A study testing Risk-stratified discharge and post-discharge care in people with Sepsis, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 59 months
- Conditions the study is for
- Sepsis
- What is being tested?
- Risk-stratified discharge and post-discharge care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,700 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2017to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under five years of age
- Admission with a proven or suspected infection
- Provide written informed consent
Who cannot join
- Refusal to participate
- Previous enrolment in the study
- Outside of hospital catchment
- Language barrier
- Direct admission following birth without having been discharged
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 2X8
Matthew O Wiens, PharmD, PhD, 604.829.2562, matthew.wiens@bcchr.ca
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Sepsis
- Being tested
- Risk-stratified discharge and post-discharge care
- Keywords
- sepsis, pediatrics, critical care, patient discharges
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-stratified discharge and post-discharge careBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Observational, children 0-59 months of age | No intervention | Phase 1: Observational only |
| Phase 2: Interventional, children 0-59 months of age | Experimental | Phase 2: Intervention Receives: Behavioral: Risk-stratified discharge and post-discharge care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge mortality
Rate of all-cause mortality within 6-months post-discharge
Measured: From discharge until 6 months post-discharge
Secondary outcomes (2)
Post-discharge re-admission
Rate of all-cause re-admissions within 6-months post-discharge.
Measured: From discharge until 6 months post-discharge
Post-discharge health seeking
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.
Measured: From discharge until 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start16 Jul 2017
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and after study
- Masking
- None (open label)
- Enrolment
- 11,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Walimu, Mbarara University of Science and Technology, Grand Challenges Canada, Thrasher Research Fund, British Columbia Childrens Hospital Foundation
- Responsible party
- Principal investigator, Matthew Wiens, University of British Columbia
- Investigators
- Matthew O Wiens, PharmD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730452
- Sponsor's protocol ID
- H16-02679
- Other IDs
- F21-05597, F17-02096, F17-02096
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Nemetchek B, English L, Kissoon N, Ansermino JM, Moschovis PP, Kabakyenga J, Fowler-Kerry S, Kumbakumba E, Wiens MO. Paediatric postdischarge mortality in developing countries: a systematic review. BMJ Open. 2018 Dec 28;8(12):e023445. doi: 10.1136/bmjopen-2018-023445.
PubMed 30593550Wiens MO, Kissoon N, Kumbakumba E, Singer J, Moschovis PP, Ansermino JM, Ndamira A, Kiwanuka J, Larson CP. Selecting candidate predictor variables for the modelling of post-discharge mortality from sepsis: a protocol development project. Afr Health Sci. 2016 Mar;16(1):162-9. doi: 10.4314/ahs.v16i1.22.
PubMed 27358628Nemetchek BR, Liang LD, Kissoon N, Ansermino JM, Kabakyenga J, Lavoie PM, Fowler-Kerry S, Wiens MO. Predictor variables for post-discharge mortality modelling in infants: a protocol development project. Afr Health Sci. 2018 Dec;18(4):1214-1225. doi: 10.4314/ahs.v18i4.43.
PubMed 30766588Wiens MO, Kumbakumba E, Larson CP, Ansermino JM, Singer J, Kissoon N, Wong H, Ndamira A, Kabakyenga J, Kiwanuka J, Zhou G. Postdischarge mortality in children with acute infectious diseases: derivation of postdischarge mortality prediction models. BMJ Open. 2015 Nov 25;5(11):e009449. doi: 10.1136/bmjopen-2015-009449.
PubMed 26608641English LL, Dunsmuir D, Kumbakumba E, Ansermino JM, Larson CP, Lester R, Barigye C, Ndamira A, Kabakyenga J, Wiens MO. The PAediatric Risk Assessment (PARA) Mobile App to Reduce Postdischarge Child Mortality: Design, Usability, and Feasibility for Health Care Workers in Uganda. JMIR Mhealth Uhealth. 2016 Feb 15;4(1):e16. doi: 10.2196/mhealth.5167.
PubMed 26879041Wiens MO, Kumbakumba E, Larson CP, Moschovis PP, Barigye C, Kabakyenga J, Ndamira A, English L, Kissoon N, Zhou G, Ansermino JM. Scheduled Follow-Up Referrals and Simple Prevention Kits Including Counseling to Improve Post-Discharge Outcomes Among Children in Uganda: A Proof-of-Concept Study. Glob Health Sci Pract. 2016 Sep 29;4(3):422-34. doi: 10.9745/GHSP-D-16-00069. Print 2016 Sep 28.
PubMed 27628107
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Discharges to Improve Post-discharge Health Outcomes in Children: A Prospective Before-after Study With Staggered Implementation
- ClinicalTrials.gov ID
- NCT05730452
- Acronym / sponsor ID
- H16-02679
- Conditions
- Sepsis
- Keywords
- sepsis, pediatrics, critical care, patient discharges
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11,700 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Walimu, Mbarara University of Science and Technology, Grand Challenges Canada, Thrasher Research Fund, British Columbia Childrens Hospital Foundation
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after study
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Observational, children 0-59 months of age | No intervention | –Phase 1: Observational only |
| Phase 2: Interventional, children 0-59 months of age | Experimental | Behavioral: Risk-stratified discharge and post-discharge carePhase 2: Intervention |
Who may qualify
- Ages
- 0 days to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children under five years of age
- Admission with a proven or suspected infection
- Provide written informed consent
Key exclusion criteria (5 listed)
- Refusal to participate
- Previous enrolment in the study
- Outside of hospital catchment
- Language barrier
- Direct admission following birth without having been discharged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-stratified discharge and post-discharge careInterventional 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) | Behavioural | Phase 2: Interventional, children 0-59 months of age |
Primary outcome
Post-discharge mortality
Time frame: From discharge until 6 months post-discharge
Rate of all-cause mortality within 6-months post-discharge
2 secondary outcomes
Post-discharge re-admission
Time frame: From discharge until 6 months post-discharge
Post-discharge health seeking
Time frame: From discharge until 6 months post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 30593550Nemetchek B, English L, Kissoon N, Ansermino JM, Moschovis PP, Kabakyenga J, Fowler-Kerry S, Kumbakumba E, Wiens MO. Paediatric postdischarge mortality in developing countries: a systematic review. BMJ Open. 2018 Dec 28;8(12):e023445. doi: 10.1136/bmjopen-2018-023445.
- Background: PubMed 27358628Wiens MO, Kissoon N, Kumbakumba E, Singer J, Moschovis PP, Ansermino JM, Ndamira A, Kiwanuka J, Larson CP. Selecting candidate predictor variables for the modelling of post-discharge mortality from sepsis: a protocol development project. Afr Health Sci. 2016 Mar;16(1):162-9. doi: 10.4314/ahs.v16i1.22.
- Background: PubMed 30766588Nemetchek BR, Liang LD, Kissoon N, Ansermino JM, Kabakyenga J, Lavoie PM, Fowler-Kerry S, Wiens MO. Predictor variables for post-discharge mortality modelling in infants: a protocol development project. Afr Health Sci. 2018 Dec;18(4):1214-1225. doi: 10.4314/ahs.v18i4.43.
- Background: PubMed 26608641Wiens MO, Kumbakumba E, Larson CP, Ansermino JM, Singer J, Kissoon N, Wong H, Ndamira A, Kabakyenga J, Kiwanuka J, Zhou G. Postdischarge mortality in children with acute infectious diseases: derivation of postdischarge mortality prediction models. BMJ Open. 2015 Nov 25;5(11):e009449. doi: 10.1136/bmjopen-2015-009449.
- Background: PubMed 26879041English LL, Dunsmuir D, Kumbakumba E, Ansermino JM, Larson CP, Lester R, Barigye C, Ndamira A, Kabakyenga J, Wiens MO. The PAediatric Risk Assessment (PARA) Mobile App to Reduce Postdischarge Child Mortality: Design, Usability, and Feasibility for Health Care Workers in Uganda. JMIR Mhealth Uhealth. 2016 Feb 15;4(1):e16. doi: 10.2196/mhealth.5167.
- Background: PubMed 27628107Wiens MO, Kumbakumba E, Larson CP, Moschovis PP, Barigye C, Kabakyenga J, Ndamira A, English L, Kissoon N, Zhou G, Ansermino JM. Scheduled Follow-Up Referrals and Simple Prevention Kits Including Counseling to Improve Post-Discharge Outcomes Among Children in Uganda: A Proof-of-Concept Study. Glob Health Sci Pract. 2016 Sep 29;4(3):422-34. doi: 10.9745/GHSP-D-16-00069. Print 2016 Sep 28.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew O Wiens, PharmD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-stratified discharge and post-discharge care in people with Sepsis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew O Wiens, PharmD, PhD (1-604-829-2562, Matthew.Wiens@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge mortality (time frame: From discharge until 6 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730452, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.