Evaluation of the FAST-M maternal sepsis bundle
| ISRCTN | ISRCTN87339737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87339737 |
| Secondary identifying numbers | RG_16-150 |
- Submission date
- 28/11/2017
- Registration date
- 13/12/2017
- Last edited
- 07/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Maternal sepsis is a life-threatening condition caused by infection during or after pregnancy or childbirth. It is the third most common direct cause of maternal death worldwide and in Malawi post-partum sepsis accounts for 9.9% of all maternal deaths. In Malawi, a report has highlighted a lack of prompt recognition and inadequate management of maternal sepsis. It concluded that the use of early warning scores and a structured approach to patient monitoring, alongside an educational programme to improve the recognition and management of maternal sepsis, would likely improve sepsis care. In high-income settings there is evidence that this approach can improve patient outcomes, but none of these interventions are specific to mothers or designed to be feasible in resource-poor settings. The development of a maternal sepsis bundle has been identified as an international priority action for the next 5 years. This study aims to find out whether the introduction of a complex intervention for maternal sepsis is feasible and improves sepsis care in resource-poor settings.
Who can participate?
Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery, and are receiving either inpatient or outpatient healthcare
What does the study involve?
After a period of 2 months when standard care is assessed across all 15 study sites, the intervention is introduced at all 15 study sites and runs for up to 10 months. All sites receive all three components of the intervention for the same duration of time each. The components include: a modified early warning score and a decision tool to enable recognition of maternal sepsis; a treatment bundle for those with suspected maternal sepsis; and a teaching programme and implementation strategy to educate healthcare practitioners on how to use the early warning scores, decision tool and treatment bundle to manage maternal sepsis.
What are the possible benefits and risks of participating?
All patients receive a maternal sepsis care bundle. Individual components of this care bundle have been shown to improve quality of care. Although rare, there is the possibility that a patient with a previously unknown penicillin allergy receives a penicillin-based antibiotic. If patient develops an anaphylactic reaction they will be treated appropriately. Clinicians are educated on the signs and symptoms of potential anaphylactic reactions during the site training. It is hoped that this study will improve antibiotic use with more appropriate and targeted prescribing, but the researchers will carefully look for and report any evidence of unnecessary or increased antibiotic prescribing. Fluid resuscitation (replacing lost bodily fluid) if not managed appropriately can cause volume overload and subsequent pulmonary oedema (fluid accumulation in the lungs). This is a particular concern in patients with pre-eclampsia (high blood pressure). Clear teaching and guidance regarding fluid resuscitation is provided during the training programme. When fluid resuscitating patients with suspected maternal sepsis, the decision regarding the rate of fluid administration is made by the responsible clinician based on clinical examination findings and ongoing monitoring. There is a possibility that the patient may further deteriorate whilst being transported to high level care, for instance from a health centre to district hospital setting or district hospital to central hospital setting. The decision to transfer a patient to higher level care is made by the clinician responsible for the patient’s care after weighing up the risks and benefits. Training and guidance regarding these considerations and localised policies is determined as part of the intervention. The researchers actively monitor to ensure patient transport for maternal sepsis care does not adversely affect the ability of any centres to transport any other patients, or adversely affect receiving institutions. Any changes in practice to improve sepsis care could inadvertently adversely affect other aspects of care, or skew resource allocation. The study has been designed and resourced with the aim of preventing any such effects, but the researchers will actively monitor for any such adverse impacts on other aspects of care within the participating centres.
Where is the study run from?
1. Dowa District Hospital (Malawi)
2. Kabudula Community Hospital (Malawi)
3. Mitundu Community Hospital (Malawi)
4. Msakambewa Health Centre (Malawi)
5. Mwangala Health Centre (Malawi)
6. Chankhungu Health Centre (Malawi)
7. Mponela Rural Hospital (Malawi)
8. Ukwe Health Centre (Malawi)
9. Malembo Health Centre (Malawi)
10. Nsaru Health Centre (Malawi)
11. Khongoni Health Centre (Malawi)
12. Dickson Health Centre (Malawi)
13. Katchale Health Centre (Malawi)
14. Chadza Health Centre (Malawi)
15. Chiwoza Health Centre (Malawi)
When is the study starting and how long is it expected to run for?
August 2016 to June 2019
Who is funding the study?
1. University of Birmingham (UK)
2. MSD for Mothers
3. Ammalife
Who is the main contact?
1. Dr James Cheshire (public)
2. Dr David Lissauer (scientific)
Contact information
Public
3rd Floor Academic Department
Birmingham Women's Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom
Scientific
3rd Floor Academic Department
Birmingham Women's Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom
Study information
| Study design | Interventional multi-centered controlled study with a before and after design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the FAST-M maternal sepsis bundle: a feasibility study |
| Study hypothesis | Introducing the FAST-M intervention into the Malawian healthcare system is feasible. |
| Ethics approval(s) | College of Medicine Research and Ethics Committee (COMREC), University of Malawi, 16/05/2017, ref: P.02/17/2112 |
| Condition | Maternal sepsis |
| Intervention | Component 1: introduction of a modified early obstetric warning score to enable the observation of patients to be recorded and also the FAST-M decision tool to enable recognition of maternal sepsis Component 2: introduction of the FAST-M treatment bundle for those with suspected maternal sepsis Component 3: introduction of a teaching programme and implementation strategy educating healthcare practitioners on how to use the early warning scores, decision tool and treatment bundle to manage maternal sepsis Control: standard care After a baseline phase of 2 months during which standard care will be assessed across all 15 study sites, the intervention phase will commence at all 15 study sites and will run for up to 10 months (or until saturation - whichever takes place first). All sites will get all 3 components of the intervention for the same duration of time each. The maintenance phase will be up to a year. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Fidelity: Time to bundle completion after recognition of sepsis. Data will be collected using specifically designed case report forms (CRFs). Data will be measured continually throughout baseline and intervention phase. 2. Number of training refresher courses: How often healthcare practitioners require training refresher sessions. Data will be measured continually throughout intervention phase. 3. Acceptability: Barriers to healthcare workers using the FAST-M toolkit. Data will be collected using a mix of semi-structured interviews and focus groups. This data will be measured at 1 month, 5 month and 6 months of intervention study. 4. Adoption: How well each healthcare facility adopts the intended practice. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection and spot audits. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of adoption. Quantitative data (spot audits and CRF data collection) will be measured continually throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study 5. Appropriateness: Is the intervention required at the study site and is it clinically relevant? Data will be collected using a mix of semi-structured interviews and focus groups. This data will be measured at 1, 5 and 6 months of intervention study. 6. Feasibility: Ability to achieve each element of the treatment bundle within the specified time limit. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection and spot audits. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of feasibility. Quantitative data (spot audits and CRF data collection) will be measured continually throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study 7. Sustainability: Ability to incorporate intervention into evidence based practice at local level. Adoption into regular practice will be assessed using CRFs and spot audits continually during intervention phase and by spot audits 4 monthly during maintenance phase. 8. Penetration: Number of healthcare workers aware of the FAST-M intervention. Data will be collected using a mix of semi-structured interviews, focus groups conducted at 1, 5 and 6 months of intervention study 9. Resource availability: Resource availability during the study period of antibiotics, intravenous fluids, blood pressure machines, thermometers, fetoscopes, ambulances. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of resource availability. Quantitative data (CRF data collection) will be measured every two weeks throughout the baseline and intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study 10. Costs: Total costs of delivering FAST-M intervention over the study period. Will be determined at end of intervention phase. 11. Unintended consequences: Any negative unintended consequences that occurred as a direct consequence of the FAST-M intervention. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the unintended consequences. Quantitative data (CRF data collection) will be measured every two weeks throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study. |
| Secondary outcome measures | 1. Pregnancy outcome: Live birth, still birth, miscarriage, induced abortion, ectopic. Data collected continually throughout study 2. Maternal morbidity: Maternal in-hospital morbidity. Data collected continually throughout study 3. Maternal mortality: Maternal in-hospital mortality. Data collected continually throughout study 4. Maternal length of stay in days. Data collected continually throughout study 5. Maternal near miss events: As defined by the WHO near miss events. Data collected continually throughout study 6. Neonatal APGAR scores at 5 minutes. Data collected continually throughout study 7. Neonatal length of stay in days. Data collected continually throughout study 8. Neonatal need for antibiotics: Whether the neonate received antibiotics. Data collected continually throughout study 9. Admission to neonatal unit: Whether the neonate was admitted to a neonatal unit. Data collected continually throughout study Other pre-specified outcome measures: 10. Theory of Change model: To prepare the FAST-M intervention for a large scale trial. Data collected continually throughout study |
| Overall study start date | 01/08/2016 |
| Overall study end date | 05/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | As this is a feasibility trial there is no target number of participants required for the study as this study is looking at whether introducing an intervention in this setting is possible. The trialists have decided that 15 sites (11 health centers, 1 rural hospital, 2 community hospitals and 1 district hospitals). However, to ensure they are 90% powered to detect an improvement in sepsis care (delivery of bundle components within 1 hour), they have estimated they will need to recruit 240 patients with maternal infections. |
| Participant inclusion criteria | 1. Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery 2. Receiving either inpatient or outpatient health care |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 05/06/2017 |
| Recruitment end date | 05/06/2018 |
Locations
Countries of recruitment
- Malawi
Study participating centres
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Malawi
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Results will be disseminated to all collaborators through quarterly interim reports and meetings with the University of Birmingham team, at in-country meetings at the individual study sites, through peer reviewed scientific journals and at national and international conferences including the College of Medicine’s Annual Research Conference 2. The study team plans the dissemination of results not only to the academic community but internationally through the WHO, FIGO and other NGOs 3. Planned publication in a high impact peer reviewed journal around one year after the overall trial date end date 4. Additional documents will not be available. Protocol is not yet published |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/10/2020 | 07/10/2020 | No | No | |
| Basic results | 04/10/2020 | 07/10/2020 | No | No |
Additional files
- ISRCTN87339737_BasicResults_04Oct2020.pdf
- Uploaded 07/10/2020
Editorial Notes
07/10/2020: The following changes have been made:
1. The basic results summary has been uploaded.
2. The intention to publish date has been changed from 05/06/2020 to 01/01/2021.
20/08/2020: Internal review.
