A multi-modal intervention to improve care of the severely ill in Uganda
| ISRCTN | ISRCTN46976783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46976783 |
| Secondary identifying numbers | SIMS 1.0 |
- Submission date
- 17/05/2017
- Registration date
- 18/05/2017
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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)
Contact information
Scientific
University of Washington School of Medicine
1959 NE Pacific Street
Seattle
-
United States of America
 ORCID ID |
0000-0003-2425-9394 |
|---|
Scientific
Yale University
School of Public Health
60 College Street
New Haven
06510
United States of America
| ORCID ID |
0000-0002-8629-9992 |
|---|
Study information
| Study design | Stepped-wedge quasi-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Stepped wedge quasi-randomized trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| 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 |
| 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/05/2014 |
| Overall study end date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6000 |
| Total final enrolment | 5759 |
| 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 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
Study participating centre
Kololo
Kampala
N/A
Uganda
Sponsor information
Other
Plot 5-7
Coral Crescent
Kololo
Kampala
-
Uganda
| Phone | +256 772 711 439 |
|---|---|
| info@walimu.org |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned for presentation at international conferences and publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/11/2017 | 26/11/2020 | Yes | No |
Editorial Notes
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
