Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial

BMC Pregnancy and Childbirth, Volume 21, No. 1, Year 2021

Interprétation

Background: Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. Methods: This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. Results: Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39–2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39–0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). Conclusions: Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. Trial registration: This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016). This is a planned secondary analysis of the CRADLE 3 trial; a pragmatic, step-wedge, cluster- randomised control trial that evaluated the CRADLE VSA intervention (CVSA device and training package) in low resource settings [1]. The CRADLE 3 intervention consisted of implementing the CRADLE VSA device and associated training package in routine community and hospital maternity care in low-resource settings. Prior to implementation of the intervention package, management was based on local guidelines and assessment of patients used varying medical devices, and this was used as a control. The trial was carried out across ten clusters over eight countries, including Addis Ababa (Ethiopia), Cap Haitien (Haiti), Freetown (Sierra Leone), Harare (Zimbabwe), Gokak (India), Kampala and Mbale (Uganda), Lusaka and Ndola (Zambia), and Zomba and the Southern Region (Malawi). Each cluster included at least one urban or peri-urban secondary or tertiary facility and multiple peripheral hospitals that referred to the region’s central hospital. In total 286 facilities and 536,223 deliveries were included in the CRADLE intervention between April 1 2016 and November 30 2017. Clusters crossed over from the control to the intervention at a randomly allocated timepoint, at 2 monthly intervals. At this randomly selected timepoint, all existing devices were replaced with the CRADLE VSA and health care providers at the facility were provided with access to the device and training package. Prior to intervention, management was based on local guidelines and assessment of patients used varying medical devices, and this was used as a control. Ethics approval was granted by the King’s College London (UK) Research Ethics Subcommittee (LRS-14/15–1484) and in all countries before the start of the trial. Institutional-level consent on behalf of the cluster was obtained. In total 3868 devices were delivered to 286 facilities. All women identified as pregnant or up to 42 days postnatal presenting to the facility were eligible to be exposed to the intervention. There were no exclusion criteria. The randomisation was the cluster. A computer-generated randomly allocated sequence run by the CRADLE statistician determined the order in which the clusters received the intervention. All clusters were masked to the order of implementation until 2 months before the intervention. Because of the nature of the intervention the trial was not masked. At each randomly allocated date, the training package was delivered to health workers in each facility by interactive group sessions. Existing equipment for vital signs observations was replaced with the CRADLE device unless specific function were required (e.g. cyclical BP monitoring in HDU). The proportion of women referred from periphery facilities to higher-level care was collected from a 4-week period before and another 4-week period repeated 3 months post-implementation. Referrals were either counted from referral registers and compared to number of patients seen in antenatal clinic or admitted to ward, or data was documented prospectively as patients were referred. It was not possible to collect accurate denominator referral data in one large site with multiple referral areas (Kampala) therefore this area was not included. Maternity staffing levels and access to essential treatment (intensive care beds, capacity for blood transfusion) were also assessed at each facility and recorded throughout the trial period. Major changes to infrastructure, patient payment requirements, or environmental conditions were systematically evaluated each month in each site. The trial ended after 20 months as planned. Reason for referral was documented as infection, bleeding, high blood pressure, labour or other (which included anaemia, malaria, early pregnancy complications). The primary outcome of the CRADLE-3 trial was a composite of at least one of eclampsia, hysterectomy or maternal death. In this analysis we reviewed the number of patients referred from primary to secondary or tertiary higher-level care for bleeding pre- and post- intervention. We report outcomes from the CRADLE-3 trial related to haemorrhage i.e. death from obstetric haemorrhage or emergency hysterectomy due to obstetric haemorrhage. We evaluated the effect of implementation on referrals for bleeding through a planned secondary analysis of the CRADLE-3 data. Odds ratios were calculated for each centre, comparing event rates pre- and post- CRADLE intervention. As there was considerable heterogeneity, random effects meta-analysis was used throughout [20]. For evaluation of outcome the CRADLE-3 trial reports the bent stick analysis. This achieves great stability to the trend-and-step pattern originally proposed in the CRADLE 3 trial, because it allows for separate linear trends in each cluster before and after intervention. Statistical analyses used Stata, version 14.2 (by PTS). This study is registered with the ISRCTN registry, number ISRCTN41244132.

Résumé de l’IA

Study Justification:

The study aimed to address the issue of obstetric hemorrhage, which is the leading cause of maternal death worldwide, particularly in low and middle-income countries. The study focused on evaluating the effectiveness of the CRADLE vital signs alert device intervention in identifying compromise and improving the management of severely compromised pregnant women. The justification for the study was to provide evidence on the potential benefit of using the CRADLE device in low-resource settings and targeting limited resources efficiently.

Highlights:

– The CRADLE-3 trial evaluated the CRADLE vital signs alert device intervention in low-resource settings across ten clusters in Africa, India, and Haiti.
– The intervention consisted of implementing the CRADLE device and associated training package in routine community and hospital maternity care.
– Referral data were collected before and after the implementation of the intervention to assess its impact on referrals for higher-level care.
– The study found a significant reduction in referrals for obstetric hemorrhage following the introduction of the CRADLE device, without an increase in maternal death or emergency hysterectomy.

Recommendations:

Based on the study findings, the following recommendations can be made:

1. The CRADLE vital signs alert device intervention should be considered for implementation in low and middle-income countries to improve the management of obstetric hemorrhage.
2. Health care providers should receive training on the proper use of the CRADLE device to ensure accurate measurements and interpretation of vital signs.
3. Further research and evaluation should be conducted to assess the long-term impact of the CRADLE device intervention on maternal outcomes and cost-effectiveness.

Key Role Players:

1. Researchers and scientists: To conduct further research and evaluation on the effectiveness of the CRADLE device intervention.
2. Health care providers: To receive training on the use of the CRADLE device and implement it in routine maternity care.
3. Policy makers: To consider the findings of the study and make decisions regarding the implementation of the CRADLE device intervention in low and middle-income countries.

Cost Items for Planning Recommendations:

1. Training programs: Budget for training health care providers on the use of the CRADLE device.
2. Procurement of CRADLE devices: Budget for purchasing an adequate number of CRADLE devices for implementation in maternity care facilities.
3. Infrastructure improvements: Budget for any necessary infrastructure improvements to support the implementation of the CRADLE device intervention.
4. Monitoring and evaluation: Budget for ongoing monitoring and evaluation of the intervention’s impact on referrals for obstetric hemorrhage and maternal outcomes.
Please note that the provided cost items are for planning purposes and do not reflect actual costs.

Force de la preuve

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong, but there are some areas for improvement. The study design is a secondary analysis of a stepped-wedge cluster-randomised control trial, which provides a solid foundation for the research. The study includes a large sample size and data from multiple countries, which increases the generalizability of the findings. The abstract provides clear information about the intervention and the outcomes measured. However, there are some limitations to consider. The abstract does not provide information about the specific methods used for data collection and analysis, which could affect the reliability of the results. Additionally, the abstract does not mention any potential confounding factors that may have influenced the results. To improve the strength of the evidence, it would be helpful to include more details about the study methods and address any potential limitations in the abstract.

Abstrait

This is a planned secondary analysis of the CRADLE 3 trial; a pragmatic, step-wedge, cluster- randomised control trial that evaluated the CRADLE VSA intervention (CVSA device and training package) in low resource settings [1]. The CRADLE 3 intervention consisted of implementing the CRADLE VSA device and associated training package in routine community and hospital maternity care in low-resource settings. Prior to implementation of the intervention package, management was based on local guidelines and assessment of patients used varying medical devices, and this was used as a control. The trial was carried out across ten clusters over eight countries, including Addis Ababa (Ethiopia), Cap Haitien (Haiti), Freetown (Sierra Leone), Harare (Zimbabwe), Gokak (India), Kampala and Mbale (Uganda), Lusaka and Ndola (Zambia), and Zomba and the Southern Region (Malawi). Each cluster included at least one urban or peri-urban secondary or tertiary facility and multiple peripheral hospitals that referred to the region’s central hospital. In total 286 facilities and 536,223 deliveries were included in the CRADLE intervention between April 1 2016 and November 30 2017. Clusters crossed over from the control to the intervention at a randomly allocated timepoint, at 2 monthly intervals. At this randomly selected timepoint, all existing devices were replaced with the CRADLE VSA and health care providers at the facility were provided with access to the device and training package. Prior to intervention, management was based on local guidelines and assessment of patients used varying medical devices, and this was used as a control. Ethics approval was granted by the King’s College London (UK) Research Ethics Subcommittee (LRS-14/15–1484) and in all countries before the start of the trial. Institutional-level consent on behalf of the cluster was obtained. In total 3868 devices were delivered to 286 facilities. All women identified as pregnant or up to 42 days postnatal presenting to the facility were eligible to be exposed to the intervention. There were no exclusion criteria. The randomisation was the cluster. A computer-generated randomly allocated sequence run by the CRADLE statistician determined the order in which the clusters received the intervention. All clusters were masked to the order of implementation until 2 months before the intervention. Because of the nature of the intervention the trial was not masked. At each randomly allocated date, the training package was delivered to health workers in each facility by interactive group sessions. Existing equipment for vital signs observations was replaced with the CRADLE device unless specific function were required (e.g. cyclical BP monitoring in HDU). The proportion of women referred from periphery facilities to higher-level care was collected from a 4-week period before and another 4-week period repeated 3 months post-implementation. Referrals were either counted from referral registers and compared to number of patients seen in antenatal clinic or admitted to ward, or data was documented prospectively as patients were referred. It was not possible to collect accurate denominator referral data in one large site with multiple referral areas (Kampala) therefore this area was not included. Maternity staffing levels and access to essential treatment (intensive care beds, capacity for blood transfusion) were also assessed at each facility and recorded throughout the trial period. Major changes to infrastructure, patient payment requirements, or environmental conditions were systematically evaluated each month in each site. The trial ended after 20 months as planned. Reason for referral was documented as infection, bleeding, high blood pressure, labour or other (which included anaemia, malaria, early pregnancy complications). The primary outcome of the CRADLE-3 trial was a composite of at least one of eclampsia, hysterectomy or maternal death. In this analysis we reviewed the number of patients referred from primary to secondary or tertiary higher-level care for bleeding pre- and post- intervention. We report outcomes from the CRADLE-3 trial related to haemorrhage i.e. death from obstetric haemorrhage or emergency hysterectomy due to obstetric haemorrhage. We evaluated the effect of implementation on referrals for bleeding through a planned secondary analysis of the CRADLE-3 data. Odds ratios were calculated for each centre, comparing event rates pre- and post- CRADLE intervention. As there was considerable heterogeneity, random effects meta-analysis was used throughout [20]. For evaluation of outcome the CRADLE-3 trial reports the bent stick analysis. This achieves great stability to the trend-and-step pattern originally proposed in the CRADLE 3 trial, because it allows for separate linear trends in each cluster before and after intervention. Statistical analyses used Stata, version 14.2 (by PTS). This study is registered with the ISRCTN registry, number ISRCTN41244132.

Matériaux

N/A

Innovations

The CRADLE Vital Signs Alert Device (CVSA) intervention was evaluated in the CRADLE 3 trial, which aimed to improve access to maternal health in low-resource settings. The CVSA device accurately measures blood pressure and heart rate, calculates the shock index, and alerts healthcare providers to compromise through a traffic light system. The trial was conducted across ten clusters in Africa, India, and Haiti, and included 536,223 deliveries.

The intervention involved implementing the CVSA device and training package in routine community and hospital maternity care. Prior to the intervention, management was based on local guidelines and varied medical devices. The clusters were randomly allocated to receive the intervention at different time points, with a 2-month interval between each allocation. The training package was delivered to healthcare workers in each facility through interactive group sessions. Existing equipment for vital signs observations was replaced with the CVSA device.

Referral data were collected before and after the implementation of the intervention. The proportion of women referred from peripheral facilities to higher-level care was recorded. The primary outcome of the trial was a composite of eclampsia, hysterectomy, or maternal death. In this analysis, the focus was on referrals for bleeding, specifically death from obstetric hemorrhage or emergency hysterectomy due to obstetric hemorrhage.

The results showed that referrals for obstetric hemorrhage reduced following the implementation of the CVSA device, without an increase in maternal death or emergency hysterectomy. The use of the shock index in management pathways for obstetric hemorrhage demonstrated the potential benefit of targeting limited resources in low- and middle-income settings.

It is important to note that this study is registered with the ISRCTN registry, number ISRCTN41244132.

AI Innovations Description

The recommendation that can be developed into an innovation to improve access to maternal health is the implementation of the CRADLE Vital Signs Alert Device (CVSA) intervention. The CVSA device accurately measures blood pressure and heart rate, calculates the shock index, and alerts the user to compromise through a traffic light system. This intervention aims to improve the early recognition of compromised pregnant women and facilitate timely transfer to tertiary centers for specialized treatment.

The effectiveness of the CVSA intervention was evaluated in the CRADLE-3 trial, a stepped-wedge cluster-randomized control trial conducted in low-middle income countries. The trial included ten clusters across Africa, India, and Haiti, where the CVSA device and training package were randomly introduced. Referral data were collected before and after implementation to assess the impact of the intervention.

The results of the trial showed a significant reduction in referrals for obstetric hemorrhage following the introduction of the CVSA device. This reduction in referrals occurred without an increase in maternal death or emergency hysterectomy. The use of the shock index in management pathways for obstetric hemorrhage proved beneficial in targeting limited resources in low-middle income settings.

To implement this innovation, healthcare facilities in low-resource settings can adopt the CRADLE Vital Signs Alert Device and provide training to healthcare providers on its proper use. The device can be integrated into routine community and hospital maternity care, enabling early identification of compromised pregnant women and facilitating timely referrals to higher-level care when necessary. This innovation has the potential to improve access to maternal health services and reduce maternal mortality and morbidity associated with obstetric hemorrhage.

AI Innovations Methodology

The CRADLE Vital Signs Alert Device (CVSA) intervention was evaluated in a secondary analysis of the CRADLE-3 trial, which aimed to improve access to maternal health in low-middle income countries. The CVSA device accurately measures blood pressure and heart rate, calculates the shock index, and alerts the user to compromise through a traffic light system. The trial was conducted across ten clusters in Africa, India, and Haiti, with the intervention randomly introduced in these clusters.

To simulate the impact of the CVSA intervention on improving access to maternal health, a methodology was employed. Referral data were collected for a 4-week period before and after the implementation of the intervention. Referrals from primary or secondary care facilities to higher-level care for any cause were recorded, and the denominator was the number of women seen for maternity care in these facilities.

The results showed that overall referrals did not significantly reduce, but there was a significant reduction in referrals for obstetric haemorrhage following the introduction of the CVSA device. This reduction in referrals for obstetric haemorrhage demonstrates the potential benefit of using the shock index in management pathways for this condition.

In terms of methodology, the trial used a pragmatic, step-wedge, cluster-randomized control design. The clusters crossed over from the control to the intervention at randomly allocated time points, with all existing devices being replaced with the CVSA device. Health care providers at the facilities were provided with access to the device and a training package.

Data on referrals were collected from referral registers or documented prospectively as patients were referred. Maternity staffing levels and access to essential treatment were also assessed at each facility. Statistical analyses, including odds ratios and random effects meta-analysis, were conducted to evaluate the effect of the intervention on referrals for bleeding.

Overall, the CRADLE-3 trial and its secondary analysis provide evidence of the potential benefits of the CVSA intervention in improving access to maternal health, particularly in reducing referrals for obstetric haemorrhage.

Auteur

Dima Health

Statistics:

Citations: 3

Identifiers:

DOI: 10.1186/s12884-021-03796-4

Research Areas:

Community Interventions, Genetics and Genomics, Health System and Policy, Infectious Diseases, Maternal Access, Maternal and Child Health, Noncommunicable Diseases, Quality of Care, Sexual and Reproductive Health, Social Determinants

Study Countries:

Ethiopia, Malawi, Multi-Countries, Sierra Leone, Uganda, Zambia, Zimbabwe

Study Design:

randomised-control-trial

Study Approach:

Mixed-methods, Quantitative, Systematic Review

Participants Gender:

Female

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