King's College London

Research portal

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

Research output: Contribution to journalArticle

Standard

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. / Vousden, Nicola; Lawley, Elodie; Nathan, Hannah L; Seed, Paul T; Brown, Adrian; Muchengwa, Tafadzwa; Charantimath, Umesh; Bellad, Mrutyunjaya; Gidiri, Muchabayiwa Francis; Goudar, Shivaprasad; Chappell, Lucy C; Sandall, Jane; Shennan, Andrew H; CRADLE Trial Collaborative Group.

In: BMC Pregnancy and Childbirth, Vol. 18, No. 1, 115, 27.04.2018.

Research output: Contribution to journalArticle

Harvard

Vousden, N, Lawley, E, Nathan, HL, Seed, PT, Brown, A, Muchengwa, T, Charantimath, U, Bellad, M, Gidiri, MF, Goudar, S, Chappell, LC, Sandall, J, Shennan, AH & CRADLE Trial Collaborative Group 2018, '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, vol. 18, no. 1, 115. https://doi.org/10.1186/s12884-018-1737-x, https://doi.org/10.1186/s12884-018-1737-x

APA

Vousden, N., Lawley, E., Nathan, H. L., Seed, P. T., Brown, A., Muchengwa, T., ... CRADLE Trial Collaborative Group (2018). 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, 18(1), [115]. https://doi.org/10.1186/s12884-018-1737-x, https://doi.org/10.1186/s12884-018-1737-x

Vancouver

Vousden N, Lawley E, Nathan HL, Seed PT, Brown A, Muchengwa T et al. 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. 2018 Apr 27;18(1). 115. https://doi.org/10.1186/s12884-018-1737-x, https://doi.org/10.1186/s12884-018-1737-x

Author

Vousden, Nicola ; Lawley, Elodie ; Nathan, Hannah L ; Seed, Paul T ; Brown, Adrian ; Muchengwa, Tafadzwa ; Charantimath, Umesh ; Bellad, Mrutyunjaya ; Gidiri, Muchabayiwa Francis ; Goudar, Shivaprasad ; Chappell, Lucy C ; Sandall, Jane ; Shennan, Andrew H ; 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. In: BMC Pregnancy and Childbirth. 2018 ; Vol. 18, No. 1.

Bibtex Download

@article{69a939a416524cabb6c87e2222d354b2,
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",
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.",
keywords = "Complex intervention, Feasibility, Implementation, Low resource, Maternal mortality, Pilot",
author = "Nicola Vousden and Elodie Lawley and Nathan, {Hannah L} and Seed, {Paul T} and Adrian Brown and Tafadzwa Muchengwa and Umesh Charantimath and Mrutyunjaya Bellad and Gidiri, {Muchabayiwa Francis} and Shivaprasad Goudar and Chappell, {Lucy C} and Jane Sandall and Shennan, {Andrew H} and {CRADLE Trial Collaborative Group}",
year = "2018",
month = "4",
day = "27",
doi = "10.1186/s12884-018-1737-x",
language = "English",
volume = "18",
journal = "BMC Pregnancy and Childbirth",
issn = "1471-2393",
publisher = "BioMed Central",
number = "1",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings

T2 - a mixed method feasibility study for the CRADLE-3 trial

AU - Vousden, Nicola

AU - Lawley, Elodie

AU - Nathan, Hannah L

AU - Seed, Paul T

AU - Brown, Adrian

AU - Muchengwa, Tafadzwa

AU - Charantimath, Umesh

AU - Bellad, Mrutyunjaya

AU - Gidiri, Muchabayiwa Francis

AU - Goudar, Shivaprasad

AU - Chappell, Lucy C

AU - Sandall, Jane

AU - Shennan, Andrew H

AU - CRADLE Trial Collaborative Group

PY - 2018/4/27

Y1 - 2018/4/27

N2 - 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.

AB - 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.

KW - Complex intervention

KW - Feasibility

KW - Implementation

KW - Low resource

KW - Maternal mortality

KW - Pilot

UR - http://www.scopus.com/inward/record.url?scp=85046154624&partnerID=8YFLogxK

U2 - 10.1186/s12884-018-1737-x

DO - 10.1186/s12884-018-1737-x

M3 - Article

C2 - 29703254

AN - SCOPUS:85046154624

VL - 18

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

SN - 1471-2393

IS - 1

M1 - 115

ER -

View graph of relations

© 2018 King's College London | Strand | London WC2R 2LS | England | United Kingdom | Tel +44 (0)20 7836 5454