Methodological Challenges and Solution Strategies During Implementation of a Midwife-led Multicentre Randomized-controlled Trial (RCT) in Maternity Hospitals

2021 ◽  
Author(s):  
Sabine Striebich ◽  
Elke Mattern ◽  
Theresa Oganowski ◽  
Rainhild Schäfers ◽  
Gertrud M. Ayerle
Keyword(s):  
Complex Intervention ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Quality Standard ◽  
Quality Data ◽  
Technical Failure ◽  
Maternity Hospitals ◽  
Study Teams ◽  
Randomised Controlled ◽  
Delivery Rooms

Abstract Background: RCTs with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (ICH-GCP guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand, such as “peak hours” of births and a high work burden for midwives and obstetricians. Moreover, in Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods: The randomised controlled trial “BE-UP” tests the effectiveness of an alternative birthing room on the rate of vaginal births and woman-oriented outcomes. In the process of implementing the trial in 17 obstetrical units and in the endeavour to reach the calculated sample size of 3,800 women, the research team encountered a variety of unexpected challenges. The aim is to describe in greater detail the methodical and organisational challenges and to inform about the research team’s strategies to overcome them.Results:The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria and strategies to offer continuous support in trial implementation must be mapped out.2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual, digital real time randomization: besides instructing the maternity teams appropriate measures for technical failure must be provided.4) The standardized birthing room: the complex intervention is to be implemented according to study protocol, yet adapted to the prevailing conditions in the delivery rooms.5) GCP-compliant documentation: midwives and obstetricians is to be instructed in high quality data collection, supported by external monitoring throughout the trial.Conclusion:Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial’s requirements.

scholarly journals Methodological challenges and solution strategies during implementation of a midwife-led multicenter randomized controlled trial (RCT) in maternity hospitals

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sabine Striebich ◽  
Elke Mattern ◽  
Theresa Oganowski ◽  
Rainhild Schäfers ◽  
Gertrud Ayerle
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Quality Data ◽  
Solution Strategies ◽  
Randomized Controlled ◽  
Link Type ◽  
Delivery Rooms

Abstract Background Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods The aim is to describe the key methodological and organizational challenges in conducting a multicenter study in maternity wards and the solution strategies applied to them. In particular, project-related and process-oriented challenges for hospital staff are considered. The exemplarily presented randomized controlled trial “BE-UP” investigates the effectiveness of an alternative design of a birthing room on the rate of vaginal births and women-specific outcomes. Results The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria, and strategies to offer continuous support in trial implementation must be mapped out. 2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual digital real-time randomization: In addition to instructing maternity teams, appropriate measures for technical failure must be provided. 4) The standardized birthing room: The complex intervention is to be implemented according to the study protocol yet adapted to the prevailing conditions in the delivery rooms. 5) GCP-compliant documentation: midwives and obstetricians will be instructed in high-quality data collection, supported by external monitoring throughout the trial. Conclusion Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial’s requirements. Trial registration The BE-UP study was registered on 07/03/ 2018 in the German Register for Clinical Trials under Reference No. DRKS00012854 and can also be found on the International Clinical Trials Registry Platform (ICTRP) (see https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS0001285).

scholarly journals Qualitative evaluation of a preventive intervention for the offspring of parents with a history of depression

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Nathalie Claus ◽  
Lisa Marzano ◽  
Johanna Loechner ◽  
Kornelija Starman ◽  
Alessandra Voggt ◽  
...  
Keyword(s):  
Preventive Intervention ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Qualitative Evaluation ◽  
Behavioural Intervention ◽  
Structured Interviews ◽  
Cognitive Behavioural ◽  
Family Based ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Background Meta-analyses of randomised controlled trials suggest that psychological interventions to reduce children’s risk of depression are effective. Nevertheless, these effects are modest and diminish over time. The Medical Research Council recommends a mixed-methods approach to the evaluation of complex interventions. By gaining a more thorough understanding of participants’ perspectives, qualitative evaluations of preventive interventions could improve their efficacy, longevity and transfer into clinical practice. Methods 18 parents and 22 children who had received a 12-session family- and group-based cognitive-behavioural intervention to prevent youth depression as part of a randomised controlled trial took part in semi-structured interviews or a focus group about aspects which had been perceived as helpful, elements they were still using after the intervention had ended, and suggestions they had for improving the intervention. Results The chance to openly share and discuss their experiences of depression within and between families was considered helpful by both children and parents. Children benefitted the most from learning coping strategies for dealing with stress and many still used them in everyday life. Parents profited mostly from increasing positive family time, but noted that maintaining new routines after the end of the intervention proved difficult. Participants were generally content with the intervention but commented on how tiring and time consuming it was. Conclusions Managing parents’ expectations of family-based interventions in terms of their own mental health needs (versus those of their children) and leaving more room for open discussions may result in interventions which are more appealing to participating families. Increasing intervals between sessions may be one means of improving the longevity of interventions. Trial registration The original RCT this evaluation is a part of was registered under NCT02115880.

scholarly journals A randomised controlled trial of a complex intervention to reduce children’s exposure to secondhand smoke in the home

2017 ◽  
Vol 27 (2) ◽  
pp. 155-162 ◽  
Author(s):  
Elena Ratschen ◽  
Rebecca Thorley ◽  
Laura Jones ◽  
Magdalena Opazo Breton ◽  
Juliette Cook ◽  
...  
Keyword(s):  
Air Quality ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Nicotine Dependence ◽  
Complex Intervention ◽  
Secondhand Smoke ◽  
Controlled Trial ◽  
Cigarette Consumption ◽  
Salivary Cotinine ◽  
Randomised Controlled

ObjectivesExposing children to secondhand tobacco smoke (SHS) causes significant harm and occurs predominantly through smoking by caregivers in the family home. We report a trial of a complex intervention designed to reduce secondhand smoke exposure of children whose primary caregiver feels unable or unwilling to quit smoking.DesignAn open-label, parallel, randomised controlled trial.SettingDeprived communities in Nottingham City and County, EnglandParticipantsCaregivers resident in Nottingham City and County in England who were at least 18 years old, the main caregiver of a child aged under 5 years living in their household, and reported that they were smoking tobacco inside their home.InterventionsWe compared a complex intervention combining personalised feedback on home air quality, behavioural support and nicotine replacement therapy for temporary abstinence with usual care.Main outcomesThe primary outcome was change in air quality in the home, measured as average 16–24  hours levels of particulate matter of  < 2.5  µm diameter (PM2.5), between baseline and 12 weeks. Secondary outcomes included changes in maximum PM2.5, proportion of time PM2.5 exceeded WHO recommended levels of maximum exposure of 25  µg/mg3, child salivary cotinine, caregivers’ cigarette consumption, nicotine dependence, determination to stop smoking, quit attempts and quitting altogether during the intervention.ResultsArithmetic mean PM2.5 decreased significantly more (by 35.2 %; 95%  CI 12.7% to 51.9 %) in intervention than in usual care households, as did the proportion of time PM2.5 exceeded 25  µg/mg3, child salivary cotinine concentrations, caregivers’ cigarette consumption in the home, nicotine dependence, determination to quit and likelihood of having made a quit attempt.ConclusionsBy reducing exposure to SHS in the homes of children who live with smokers unable or unwilling to quit, this intervention offers huge potential to reduce children’s’ tobacco-related harm.Trial registration numberISRCTN81701383.This trial was funded by the UK National Institute for Health Research (NIHR): RP-PG-0608-10020

scholarly journals RelAte: pilot study of the effects of a mealtime intervention on social cognitive factors and energy intake among older adults living alone

2016 ◽  
Vol 116 (9) ◽  
pp. 1573-1581 ◽  
Author(s):  
Joanna E. McHugh Power ◽  
Olga Lee ◽  
Niamh Aspell ◽  
Emma McCormack ◽  
Michelle Loftus ◽  
...  
Keyword(s):  
Older Adults ◽  
Treatment Group ◽  
Energy Intake ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Living Alone ◽  
Control Group ◽  
Nutritional Interventions ◽  
Randomised Controlled

AbstractMealtime interventions typically focus on institutionalised older adults, but we wanted to investigate whether they may also be effective among those living independently. Using a randomised controlled trial design, we assessed the effects of a novel mealtime intervention on self-efficacy, food enjoyment and energy intake. A total of 100 adults living alone aged over 60 years were randomised to the treatment or control conditions: all received a guidebook on nutrition and culinary skills. Treatment group participants received a weekly visit from a trained volunteer who prepared and shared a meal with them. Participants in the treatment group showed improvements relative to those in the control group at borderline significance (P=0·054) for self-efficacy and at significance for food enjoyment. Significant improvements were observed in female participants in the treatment but not in the control group in energy intake (although following corrections for multiple comparisons, only the effect on food enjoyment remained significant). These findings will inform the design of future complex interventions. For this type of intervention to be successful, more focus has to be placed on making interventions more personalised, potentially according to sex. Findings are important for nutritional sciences as they indicate that, in order to improve energy intake and food enjoyment among older adults, multimodal nutritional interventions including social components may be successful.

scholarly journals Full title: My Baby’s Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

2021 ◽  
Author(s):  
Vicki Flenady ◽  
Glen Gardener ◽  
David Ellwood ◽  
Michael Coory ◽  
Megan Weller ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stillbirth Rate ◽  
Stepped Wedge ◽  
Calendar Time ◽  
Cluster Randomised ◽  
Maternity Hospitals ◽  
Randomised Controlled ◽  
The Impact

Objective The My Baby’s Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (MBM intervention). Design Stepped-wedge cluster-randomised controlled trial. Setting Twenty-seven maternity hospitals in Australia and New Zealand. Population Women with a singleton pregnancy without major fetal anomaly ≥28 weeks’ gestation from August 2016-May 2019. Methods The MBM intervention was implemented at randomly assigned time points with sequential introduction into 8 clusters of 3-5 hospitals at four-monthly intervals. The stillbirth rate was compared in the control and intervention periods. Generalised linear mixed models controlled for calendar time, clustering, and hospital effects. Outcome Measures Stillbirth at ≥28 weeks’ gestation. Results There were 304,853 births with 290,219 meeting inclusion criteria: 150,079 in control and 140,140 in intervention periods. The stillbirth rate during the intervention was lower than the control period (2.2/1000 births versus 2.4, odds ratio [OR] 0.91, 95% Confidence Intervals [CI] 0.78-1.06, p=0.22). The decrease was larger across calendar time with 2.7/1000 in the first 18 months versus 2.0/1000 in the last 18 months (OR 0.74; 95% CI 0.63-0.86; p≤0.01). Following adjustment, stillbirth rates between the control and intervention periods were not significantly different: (aOR 1.18, 95% CI 0.93-1.50; p=0.18). No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. Conclusion The MBM intervention did not reduce stillbirths beyond the downward trend over time, suggesting hospitals may have implemented best practice in DFM management outside their randomisation schedule. The role of interventions for raising awareness of DFM remains unclear

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