THISTLE: trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial

ObjectiveTo assess whether the implementation of an intrapartum training package (PROMPT (PRactical Obstetric Multi-Professional Training)) across a health service reduced the proportion of term babies born with Apgar score <7 at 5 min (<75mins).DesignStepped-wedge cluster randomised controlled trial.SettingTwelve randomised maternity units with ≥900 births/year in Scotland. Three additional units were included in a supplementary analysis to assess the effect across Scotland. The intervention commenced in March 2014 with follow-up until September 2016.InterventionThe PROMPT training package (Second edition), with subsequent unit-level implementation of PROMPT courses for all maternity staff.Main outcome measuresThe primary outcome was the proportion of term babies with Apgar<75mins.Results87 204 eligible births (99.2% with an Apgar score), of which 1291 infants had an Apgar<75mins were delivered in the 12 randomised maternity units. Two units did not implement the intervention. The overall Apgar<75mins rate observed in the 12 randomised units was 1.49%, increasing from 1.32% preintervention to 1.59% postintervention. Once adjusted for a secular time trend, the ‘intention-to-treat’ analysis indicated a moderate but non-significant reduction in the rate of term babies with an Apgar scores <75mins following PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). However, some units implemented the intervention earlier than their allocated step, whereas others delayed the intervention. The content and authenticity of the implemented intervention varied widely at unit level. When the actual date of implementation of the intervention in each unit was considered in the analysis, there was no evidence of improvement (OR=1.01 (0.84 to 1.22)). No intervention effect was detected by broadening the analysis to include all 15 large Scottish maternity units. Units with a history of higher rates of Apgar<75mins maintained higher Apgar rates during the study (OR=2.09 (1.28 to 3.41)) compared with units with pre-study rates aligned to the national rate.ConclusionsPROMPT training, as implemented, had no effect on the rate of Apgar <75mins in Scotland during the study period. Local implementation at scale was found to be more difficult than anticipated. Further research is required to understand why the positive effects observed in other single-unit studies have not been replicated in Scottish maternity units, and how units can be best supported to locally implement the intervention authentically and effectively.Trial registration numberISRCTN11640515.

Download Full-text

Agents of change among people living with HIV and their social networks: stepped-wedge randomised controlled trial of the NAMWEZA intervention in Dar es Salaam, Tanzania

BMJ Global Health ◽

10.1136/bmjgh-2018-000946 ◽

2019 ◽

Vol 4 (3) ◽

pp. e000946 ◽

Cited By ~ 5

Author(s):

Mary C Smith Fawzi ◽

Hellen Siril ◽

Yuanyuan Liu ◽

Keith McAdam ◽

Donald Ainebyona ◽

...

Keyword(s):

Social Networks ◽

Randomised Controlled Trial ◽

Hiv Risk ◽

Controlled Trial ◽

Risk Behaviour ◽

Dar Es Salaam ◽

People Living With Hiv ◽

Stepped Wedge ◽

Randomised Controlled ◽

Living With Hiv

IntroductionNAMWEZA is a novel intervention that focuses on preventing HIV and promoting sexual and reproductive health and rights by addressing underlying factors related to vulnerability of acquiring HIV, such as depression, intimate partner violence (IPV) and stigma. The goal of the study was to evaluate the effect of the NAMWEZA intervention on risk behaviour as well as factors potentially contributing to this vulnerability for people living with HIV and their network members.MethodsA stepped-wedge randomised controlled trial was conducted from November 2010 to January 2014 among people living with HIV and their network members in Dar es Salaam, Tanzania. 458 people living with HIV were randomised within age/sex-specific strata to participate in the NAMWEZA intervention at three points in time. In addition, 602 members of their social networks completed the baseline interview. Intention-to-treat analysis was performed, including primary outcomes of uptake of HIV services, self-efficacy, self-esteem, HIV risk behaviour and IPV.ResultsFor people living with HIV, a number of outcomes improved with the NAMWEZA intervention, including higher self-efficacy and related factors, as well as lower levels of depression and stigma. IPV reduced by 40% among women. Although reductions in HIV risk behaviour were not observed, an increase in access to HIV treatment was reported for network members (72% vs 94%, p=0.002).ConclusionThese results demonstrate the complexity of behavioural interventions in reducing the vulnerability of acquiring HIV, since it is possible to observe a broad range of different outcomes. This study indicates the importance of formally evaluating interventions so that policymakers can build on evidence-based approaches to advance the effectiveness of HIV prevention interventions.Trial registration numberNCT01693458.

Download Full-text