Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial
Abstract Background The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on com...
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BMC
2018-04-01
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Series: | BMC Pregnancy and Childbirth |
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Online Access: | http://link.springer.com/article/10.1186/s12884-018-1737-x |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nicola Vousden Elodie Lawley Hannah L. Nathan Paul T. Seed Adrian Brown Tafadzwa Muchengwa Umesh Charantimath Mrutyunjaya Bellad Muchabayiwa Francis Gidiri Shivaprasad Goudar Lucy C. Chappell Jane Sandall Andrew H. Shennan on behalf of the CRADLE Trial Collaborative Group |
spellingShingle |
Nicola Vousden Elodie Lawley Hannah L. Nathan Paul T. Seed Adrian Brown Tafadzwa Muchengwa Umesh Charantimath Mrutyunjaya Bellad Muchabayiwa Francis Gidiri Shivaprasad Goudar Lucy C. Chappell Jane Sandall Andrew H. Shennan on behalf of the CRADLE Trial Collaborative Group Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial BMC Pregnancy and Childbirth Complex intervention Maternal mortality Low resource Feasibility Pilot Implementation |
author_facet |
Nicola Vousden Elodie Lawley Hannah L. Nathan Paul T. Seed Adrian Brown Tafadzwa Muchengwa Umesh Charantimath Mrutyunjaya Bellad Muchabayiwa Francis Gidiri Shivaprasad Goudar Lucy C. Chappell Jane Sandall Andrew H. Shennan on behalf of the CRADLE Trial Collaborative Group |
author_sort |
Nicola Vousden |
title |
Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial |
title_short |
Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial |
title_full |
Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial |
title_fullStr |
Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial |
title_full_unstemmed |
Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial |
title_sort |
evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the cradle-3 trial |
publisher |
BMC |
series |
BMC Pregnancy and Childbirth |
issn |
1471-2393 |
publishDate |
2018-04-01 |
description |
Abstract Background The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. Methods The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4–10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. Results The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. Conclusions This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. Trial registration ISRCTN41244132; Registered 24/11/2015. |
topic |
Complex intervention Maternal mortality Low resource Feasibility Pilot Implementation |
url |
http://link.springer.com/article/10.1186/s12884-018-1737-x |
work_keys_str_mv |
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doaj-6896e5106aaa4c7b83ee5dfb94062e012020-11-25T01:57:59ZengBMCBMC Pregnancy and Childbirth1471-23932018-04-0118111110.1186/s12884-018-1737-xEvaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trialNicola Vousden0Elodie Lawley1Hannah L. Nathan2Paul T. Seed3Adrian Brown4Tafadzwa Muchengwa5Umesh Charantimath6Mrutyunjaya Bellad7Muchabayiwa Francis Gidiri8Shivaprasad Goudar9Lucy C. Chappell10Jane Sandall11Andrew H. Shennan12on behalf of the CRADLE Trial Collaborative GroupDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonMaternity Worldwide Community BaseMorgenster Mission HospitalWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical CollegeWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical CollegeDepartment of Obstetrics and Gynaecology, College of Health Sciences, University of ZimbabweWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical CollegeDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College LondonAbstract Background The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. Methods The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4–10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. Results The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. Conclusions This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. Trial registration ISRCTN41244132; Registered 24/11/2015.http://link.springer.com/article/10.1186/s12884-018-1737-xComplex interventionMaternal mortalityLow resourceFeasibilityPilotImplementation |