Condition category
Signs and Symptoms
Date applied
17/05/2017
Date assigned
18/05/2017
Last edited
18/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Globally, there is a high burden of severe illness and associated deaths in low-income countries. To improve management of severely ill patients in hospital in low-income settings, the World Health Organization (WHO), through its program on the Integrated Management of Adolescent and Adult Illness, established a triage tool (a tool used to help decide the order of treatment) called “Quick Check” to provide clinicians with a rapid, standardised approach to identifying patients with severe illness based on recognising of abnormal vital signs. The aims of this study are to determine the impact of the WHO QuickCheck+ training program and the Severe Illness Management System (SIMS) program on how well severely ill patients can be identified and to identify and test methods of improving the way in which best care for severely ill patients can be followed in low-income settings.

Who can participate?
Patients aged 14 years and over who have been admitted to the general medical wards through the casualty department at participating hospitals.

What does the study involve?
The study involves an intervention designed to improve health worker performance of vital sign collection and diagnosis of severe illness conditions. Intervention components include clinical mentoring by an expert in severe illness care, collaborative improvement meetings with external support supervision, and continuous audits of clinical performance with structured feedback. All health facilities in the study will receive the intervention but at different times.

What are the possible benefits and risks of participating?
Participants could benefit from improved identification of their illness so that they can be better managed in hospital. There are no notable risks involved with participating.

Where is the study run from?
The study is taking place at four inpatient health facilities in one district of western Uganda.

When is study starting and how long is it expected to run for?
August 2014 to May 2015

Who is funding the study?
1. World Health Organization (Switzerland)
2. Cooperative Biological Engagement Program (USA)
3. IMAI Alliance (USA)
4. Anonymous European Family Foundation

Who is the main contact?
1. Dr. Shevin Jacob (scientific)
shevin@walimu.org
2. Dr J. Lucian Davis (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shevin Jacob

ORCID ID

http://orcid.org/0000-0003-2425-9394

Contact details

University of Washington School of Medicine
1959 NE Pacific Street
Seattle
-
United States of America

Type

Scientific

Additional contact

Dr J. Lucian Davis

ORCID ID

http://orcid.org/0000-0002-8629-9992

Contact details

Yale University
School of Public Health
60 College Street
New Haven
06510
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SIMS 1.0

Study information

Scientific title

A complex intervention to improve implementation of World Health Organization guidelines for diagnosis of severe illness in low-income settings: a quasi-randomized trial from Uganda

Acronym

Study hypothesis

The overall aim of this project is to improve the management of severely ill patients at four hospitals in western Uganda.

The specific aims of this project are:
1. To determine the impact of the WHO QuickCheck+ training program and the Severe Illness Management System (SIMS) program on process measures related to the identification of severely ill patients
2. To identify and test methods of improving adherence to evidence-based care for severely ill patients in low-income settings

Ethics approval

1. The Makerere University School of Public Health Higher Degrees, Research, and Ethics Committee
2. The Uganda National Council for Science and Technolog
3. The University of California San Francisco Committee on Human Research
4. The Human Investigation Committee, Yale University

Study design

Stepped-wedge quasi-randomized trial

Primary study design

Interventional

Secondary study design

Stepped wedge quasi-randomized trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Severe illness conditions as defined by WHO Quick Check+ (shock, sepsis, severe respiratory distress, altered mental status)

Intervention

This study consists of a behavioral intervention to improve health care worker performance. The intervention is comprised of three modalities: clinical mentoring by an expert in severe illness care, collaborative improvement meetings with external support supervision, and continuous audits of clinical performance with structured feedback. There is no follow up. The intervention is implemented using a quasi-randomised, stepped-wedge design. The sequence for introducing the intervention is randomly assigned, with a new site launching approximately every six weeks and an a priori plan to launch two sites simultaneously.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Vital sign collection and diagnosis of severe illness conditions, determined via review of medical charts, at time of hospital admission

Secondary outcome measures

Vital status, specifically mortality, determined via review of medical charts, at the time of hospital discharge

Overall trial start date

01/05/2014

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 14 years and over
2. Admitted to the general medical wards through the casualty department at each health facility

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6000

Participant exclusion criteria

Those whose primary admitting diagnosis is an emergent surgical or obstetrical condition.

Recruitment start date

01/08/2014

Recruitment end date

31/05/2015

Locations

Countries of recruitment

Uganda

Trial participating centre

Walimu
Plot 5-7, Coral Crescent Kololo
Kampala
N/A
Uganda

Sponsor information

Organisation

Walimu

Sponsor details

Plot 5-7
Coral Crescent
Kololo
Kampala
-
Uganda
+256 772 711 439
info@walimu.org

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

World Health Organization

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Funder name

Cooperative Biological Engagement Program

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

IMAI Alliance

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anonymous European Family Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned for presentation at international conferences and publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr J. Lucian Davis (lucian.davis@yale.edu).

Intention to publish date

31/12/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes