Dataset Information

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.

SUBMITTER: Vousden N

PROVIDER: S-EPMC5924508 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 N Lawley Elodie E Nathan Hannah L HL Seed Paul T PT Brown Adrian A Muchengwa Tafadzwa T Charantimath Umesh U Bellad Mrutyunjaya M Gidiri Muchabayiwa Francis MF Goudar Shivaprasad S Chappell Lucy C LC Sandall Jane J Shennan Andrew H AH

BMC pregnancy and childbirth 20180427 1

<h4>Background</h4>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 feasibili ...[more]

PMID: 29703254

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Project description:BackgroundIn 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132.FindingsBetween April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86-0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73-2·06; p=0·45).InterpretationThere was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.FundingNewton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

Project description:BACKGROUND:Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. METHODS:Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n =?205) and pregnant women and their family members (n =?41). Interviews and focus groups were conducted in the local language and audio-recorded, transcribed and translated into English for analysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach. RESULTS:Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights early warning system was unanimously reported positively, giving healthcare workers confidence with decision-making and a sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly when measuring vital signs in obese and hypertensive women (n?=?4) and a few South African healthcare workers distrusted the device's accuracy (n =?7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warning system gave women and their families a better understanding of the importance of vital signs in pregnancy and during the postpartum period. CONCLUSION:The CRADLE device was well accepted by healthcare workers from a range of countries and levels of facility, including those with no previous vital signs measurement experience. The device motivated women to attend primary care and encouraged them to accept treatment and referral.

Project description:BackgroundInterventions aimed at reducing maternal mortality are increasingly complex. Understanding how complex interventions are delivered, to whom, and how they work is key in ensuring their rapid scale-up. We delivered a vital signs triage intervention into routine maternity care in eight low- and middle-income countries with the aim of reducing a composite outcome of morbidity and mortality. This was a pragmatic, hybrid effectiveness-implementation stepped-wedge randomised controlled trial. In this study, we present the results of the mixed-methods process evaluation. The aim was to describe implementation and local context and integrate results to determine whether differences in the effect of the intervention across sites could be explained.MethodsThe duration and content of implementation, uptake of the intervention and its impact on clinical management were recorded. These were integrated with interviews (n = 36) and focus groups (n = 19) at 3 months and 6-9 months after implementation. In order to determine the effect of implementation on effectiveness, measures were ranked and averaged across implementation domains to create a composite implementation strength score and then correlated with the primary outcome.ResultsOverall, 61.1% (n = 2747) of health care providers were trained in the intervention (range 16.5% to 89.2%) over a mean of 10.8 days. Uptake and acceptability of the intervention was good. All clusters demonstrated improved availability of vital signs equipment. There was an increase in the proportion of women having their blood pressure measured in pregnancy following the intervention (79.2% vs. 97.6%; OR 1.30 (1.29-1.31)) and no significant change in referral rates (3.7% vs. 4.4% OR 0.89; (0.39-2.05)). Availability of resources and acceptable, effective referral systems influenced health care provider interaction with the intervention. There was no correlation between process measures within or between domains, or between the composite score and the primary outcome.ConclusionsThis process evaluation has successfully described the quantity and quality of implementation. Variation in implementation and context did not explain differences in the effectiveness of the intervention on maternal mortality and morbidity. We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways.Trial registrationTrial registration: ISRCTN41244132 . Registered on 2 Feb 2016.

Project description:BackgroundObstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations.MethodsThe CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken.DiscussionAll aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers.Trial registrationISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.

Project description:BackgroundHospital stays after colorectal surgery are increasingly being reduced by enhanced recovery and early discharge protocols. As a result, postoperative complications may frequently manifest after discharge in the home setting, potentially leading to emergency room presentations and readmissions. Virtual care interventions after hospital discharge may capture clinical deterioration at an early stage and hold promise for the prevention of readmissions and overall better outcomes. Recent technological advances have enabled continuous vital sign monitoring by wearable wireless sensor devices. However, the potential of these devices for virtual care interventions for patients discharged after colorectal surgery is currently unknown.ObjectiveWe aimed to determine the feasibility of a virtual care intervention consisting of continuous vital sign monitoring with wearable wireless sensors and teleconsultations for patients discharged after colorectal surgery.MethodsIn a single-center observational cohort study, patients were monitored at home for 5 consecutive days after discharge. Daily vital sign trend assessments and telephone consultations were performed by a remote patient-monitoring department. Intervention performance was evaluated by analyzing vital sign trend assessments and telephone consultation reports. Outcomes were categorized as "no concern," "slight concern," or "serious concern." Serious concern prompted contact with the surgeon on call. In addition, the quality of the vital sign data was determined, and the patient experience was evaluated.ResultsAmong 21 patients who participated in this study, 104 of 105 (99%) measurements of vital sign trends were successful. Of these 104 vital sign trend assessments, 68% (n=71) did not raise any concern, 16% (n=17) were unable to be assessed because of data loss, and none led to contacting the surgeon. Of 62 of 63 (98%) successfully performed telephone consultations, 53 (86%) did not raise any concerns and only 1 resulted in contacting the surgeon. A 68% agreement was found between vital sign trend assessments and telephone consultations. Overall completeness of the 2347 hours of vital sign trend data was 46.3% (range 5%-100%). Patient satisfaction score was 8 (IQR 7-9) of 10.ConclusionsA home monitoring intervention of patients discharged after colorectal surgery was found to be feasible, given its high performance and high patient acceptability. However, the intervention design needs further optimization before the true value of remote monitoring for early discharge protocols, prevention of readmissions, and overall patient outcomes can be adequately determined.

Dataset Information

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.

Background

Methods

Results

Conclusions

Trial registration

Publications

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.

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