Dataset Information

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial.

ABSTRACT:

Background

Indigenous women in the southern Mexican state of Guerrero face poor maternal health outcomes. Living as they do at the very periphery of the Western health system, they often receive low-quality care from health services that lack human and financial resources. Traditional health systems remain active in indigenous communities where traditional midwives accompany women through motherhood. Several interventions have explored training birth attendants in Western birthing skills, but little research has focussed on supporting traditional midwives by recognising their knowledge. This trial supports traditional midwifery in four indigenous groups and measures its impact on maternal health outcomes.

Methods

The study includes four indigenous populations in the State of Guerrero (Nahua, Na savi/Mixteco, Me'phaa/Tlapaneco and Nancue ñomndaa/Amuzgo), covering approximately 8000 households. A parallel-group cluster-randomised controlled trial will compare communities receiving usual care with communities where traditional midwives received support in addition to the usual care. The intervention was defined in collaboration with participants in a 2012 pilot study. Supported midwives will receive a small stipend, a scholarship to train one apprentice, and support from an intercultural broker to deal with Western health personnel; additionally, the health staff in the intervention municipalities will participate in workshops to improve understanding and attitudes towards authentic traditional midwives. A baseline and a final survey will measure changes in birth and pregnancy complications (primary outcomes), and changes in gender violence, access to healthcare, and engagement with traditional cultural activities (secondary outcomes). The project has ethical approval from the participating communities and the Universidad Autónoma de Guerrero.

Discussion

Indigenous women at the periphery of Western health services do not benefit fully from the attenuated services which erode their own healthcare traditions. Western health service providers in indigenous communities often ignore traditional knowledge and resources, inadvertently or in ignorance, disrespecting indigenous cultures. Improved understanding between midwives and the official healthcare system can contribute to more appropriate referral of high-risk cases, improving the use of scarce resources while lowering costs of healthcare for indigenous families.

Trial registration

ISRCTN12397283 . Retrospectively registered on 6 December 2016.

SUBMITTER: Sarmiento I

PROVIDER: S-EPMC6033215 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial.

Sarmiento Iván I Paredes-Solís Sergio S Andersson Neil N Cockcroft Anne A

Trials 20180704 1

<h4>Background</h4>Indigenous women in the southern Mexican state of Guerrero face poor maternal health outcomes. Living as they do at the very periphery of the Western health system, they often receive low-quality care from health services that lack human and financial resources. Traditional health systems remain active in indigenous communities where traditional midwives accompany women through motherhood. Several interventions have explored training birth attendants in Western birthing skills ...[more]

PMID: 29973241

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Project description:BackgroundAvailable research on the contribution of traditional midwifery to safe motherhood focuses on retraining and redefining traditional midwives, assuming cultural prominence of Western ways. Our objective was to test if supporting traditional midwives on their own terms increases cultural safety (respect of Indigenous traditions) without worsening maternal health outcomes.MethodsPragmatic parallel-group cluster-randomised controlled non-inferiority trial in four municipalities in Guerrero State, southern Mexico, with Nahua, Na savi, Me'phaa and Nancue ñomndaa Indigenous groups. The study included all pregnant women in 80 communities and 30 traditional midwives in 40 intervention communities. Between July 2015 and April 2017, traditional midwives and their apprentices received a monthly stipend and support from a trained intercultural broker, and local official health personnel attended a workshop for improving attitudes towards traditional midwifery. Forty communities in two control municipalities continued with usual health services. Trained Indigenous female interviewers administered a baseline and follow-up household survey, interviewing all women who reported pregnancy or childbirth in all involved municipalities since January 2016. Primary outcomes included childbirth and neonatal complications, perinatal deaths, and postnatal complications, and secondary outcomes were traditional childbirth (at home, in vertical position, with traditional midwife and family), access and experience in Western healthcare, food intake, reduction of heavy work, and cost of health care.ResultsAmong 872 completed pregnancies, women in intervention communities had lower rates of primary outcomes (perinatal deaths or childbirth or neonatal complications) (RD -0.06 95%CI - 0.09 to - 0.02) and reported more traditional childbirths (RD 0.10 95%CI 0.02 to 0.18). Among institutional childbirths, women from intervention communities reported more traditional management of placenta (RD 0.34 95%CI 0.21 to 0.48) but also more non-traditional cold-water baths (RD 0.10 95%CI 0.02 to 0.19). Among home-based childbirths, women from intervention communities had fewer postpartum complications (RD -0.12 95%CI - 0.27 to 0.01).ConclusionsSupporting traditional midwifery increased culturally safe childbirth without worsening health outcomes. The fixed population size restricted our confidence for inference of non-inferiority for mortality outcomes. Traditional midwifery could contribute to safer birth among Indigenous communities if, instead of attempting to replace traditional practices, health authorities promoted intercultural dialogue.Trial registrationRetrospectively registered ISRCTN12397283 . Trial status: concluded.

Project description:ObjectivesExplore the acceptability and feasibility of a randomised controlled trial (RCT) to assess game jams-participatory events to cocreate digital or board games in a time-constrained environment-in cultural safety training of medical students. The pilot tests methods and procedures and explores the validity and reliability of our research instrument.DesignTwo-arm parallel-group pilot RCT with a 1:1 allocation ratio.SettingFaculty of Medicine in Chia, Colombia.Participants79 final-year medical students completed the baseline questionnaire. 64 completed the assessment immediately after the intervention: 31 in the intervention group (20 female) and 33 in the control group (18 female). 35 completed the final assessment (18 control and 17 intervention) 4 months after the intervention.InterventionsThe intervention group joined a 5-hour game jam composed of a 1-hour lecture and a 4-hour session to create and to play educational games about cultural safety. The control group had a 1-hour conventional lesson, followed by a 4-hour study session of selected readings on cultural safety.Primary and secondary outcome measuresThe instrument, an online self-administered Likert-type questionnaire, assessed a self-reported cultural safety results chain based on a planned behaviour theory. Student recruitment, retention and perception of the activity determined acceptability. The methodological and logistical factors for a full-scale study determined feasibility.ResultsAfter the intervention, students randomised to that arm reported a slightly higher cultural safety score (26.9) than those in the control group (25.9) (difference -1, 95% CI -3.0 to 1.0). Students described game jam learning in favourable terms and considered cultural safety training relevant. The university authorised the conduct of the full-scale trial.ConclusionGame jam learning is feasible and acceptable for cultural safety training of Colombian medical students. Researchers and educators may find our results informative in the design of RCTs assessing educational interventions.Trial registration numberISRCTN14261595 (stage: pilot study results).

Project description:INTRODUCTION:Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS:Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION:The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER:ISCTRN83964946 (Pre-results) IRAS 213527.

Project description:BackgroundCultural safety, whereby health professionals respect and promote the cultural identity of patients, could reduce intercultural tensions that hinder patient access to effective health services in Colombia. Game jams are participatory events to create educational games, a potentially engaging learning environment for Millennial medical students. We set out to determine whether medical student participation in a game jam on cultural safety is more effective than more conventional education in changing self-reported intended patient-oriented behavior and confidence in transcultural skills.MethodsWe conducted a parallel-group, two-arm randomized controlled trial with 1:1 allocation. Colombian medical students and medical interns at University of La Sabana participated in the trial. The intervention was a game jam to create an educational game on cultural safety, and the reference was a standard lesson plus an interactive workshop on cultural safety. Both sessions lasted eight hours. Stratified randomization allocated the participants to the intervention and control groups, with masked allocation until commencement.Results531 students completed the baseline survey, 347 completed the survey immediately after the intervention, and 336 completed the survey after 6 months. After the intervention, game jam participants did not have better intentions of culturally safe behaviour than did participants in the reference group (difference in means: 0.08 95% CI - 0.05 to 0.23); both groups had an improvement in this outcome. Multivariate analysis adjusted by clusters confirmed that game jam learning was associated with higher transcultural self-efficacy immediately after the intervention (wt OR 2.03 cl adj 95% CI 1.25-3.30).ConclusionsGame jam learning improved cultural safety intentions of Colombian medical students to a similar degree as did a carefully designed lecture and interactive workshop. The game jam was also associated with positive change in participant transcultural self-efficacy. We encourage further research to explore the impact of cultural safety training on patient-related outcomes. Our experience could inform initiatives to introduce cultural safety training in other multicultural settings.Trial registrationRegistered on ISRCTN registry on July 18th 2019. Registration number: ISRCTN14261595 .

Project description:BACKGROUND:Cultural safety encourages practitioners to examine how their own culture shapes their clinical practice and to respect their patients' worldviews. Lack of cultural safety in health care is linked to stigma and discrimination toward culturally diverse patients. Training in cultural safety poses considerable challenges. It is an unappealing subject for medical students and requires behavioral changes in their clinical practice. Game jams-collaborative workshops to create and play games-have recently shown effectiveness and engaging potential in university-level education. OBJECTIVE:The trial aims to determine if medical students' participation in a game jam to design an educational game on cultural safety is more effective than a standard lesson on cultural safety in terms of change in the students' self-reported intended patient-oriented behavior. METHODS:A parallel-group, 2-arm randomized controlled trial with a 1:1 allocation ratio will randomize 340 medical students and 60 medical interns (n=400) at the Faculty of Medicine at La Sabana University, Colombia (170 students and 30 medical interns to each arm). The intervention group will participate in an 8-hour game jam comprising (1) a preliminary lecture on cultural safety and game design, (2) a game building session where groups of students will create educational games about cultural safety, and (3) a play-test session in which students will play and learn from each other's games. The control group will receive a standard lesson, including a 2-hour lecture on cultural safety, followed by a 6-hour workshop to create posters about cultural safety. Web-based self-administered 30-item Likert-type questionnaires will assess cultural safety self-reported intended behavior before, immediately after, and 6 months after the intervention. An intention-to-treat approach will use a t-test with 95% CIs to determine the significance of the effect of the intervention, including within- and between-group comparisons. The qualitative most significant change technique will explore the impact of the intervention on the clinical experience of the students. RESULTS:Study enrollment began in July 2019. A total of 531 students completed the baseline survey and were randomized. Data collection is expected to be complete by July 2020, and results are expected in October 2020. The study was approved by the institutional review board of the Faculty of Medicine at McGill University (May 31, 2017) and by the Subcommittee for Research of the Faculty of Medicine at La Sabana University (approval number 445). CONCLUSIONS:The research will develop participatory methods in game-based learning co-design that might be relevant to other subjects. Ultimately, it should foster improved cultural safety skills for medical students, improve the quality of health services for diverse cultural groups, and contribute to enhanced population health. Game learning may provide an innovative solution to a long-standing and neglected problem in medical education, helping to meet the educational expectations and needs of millennial medical students. TRIAL REGISTRATION:ISRCTN Registry ISRCTN14261595; http://www.controlled-trials.com/ISRCTN14261595.

Project description:BackgroundChildren have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children's attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain.ObjectiveThe aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children's functioning and psychosocial difficulties.MethodsThis study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game-based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed.ResultsThis project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period.ConclusionsIf the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public.Trial registrationClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196.International registered report identifier (irrid)PRR1-10.2196/17756.

Project description:IntroductionCrohn's disease (CD) is a chronic inflammatory bowel disease with a heterogeneous clinical presentation, relapse rate and treatment response. At present, no markers are available to adequately predict disease course at diagnosis. To prevent overtreatment of patients with a relative mild disease course, a step-up approach starting with corticosteroids is usually applied. Timely introduction of potentially disease modifying drugs and tight control of mucosal inflammation are crucial to prevent disease-related complications in patients with a complex disease course. We hypothesise that episodic treatment with adalimumab monotherapy in combination with close monitoring after drug discontinuation improves long-term outcome and reduces drug-related side effects, while preventing overtreatment.Methods and analysisIn this pragmatic multicentre randomised controlled trial, newly diagnosed CD patients or CD patients with a flare, naïve to thiopurines and biologicals, will be included and randomised 1:1 to open-label episodic (ie, 24 weeks) adalimumab monotherapy or step-up care starting with corticosteroids. The primary outcome is the number of yearly quarters of corticosteroid free clinical (Monitor Inflammatory Bowel Disease At Home score ≤3) and biochemical (C reactive protein within normal range and faecal calprotectin ≤200 µg/g) remission at week 96. Secondary outcomes are total healthcare costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, corticosteroid-free clinical remission, time to remission and patient-reported outcome measures on quality of life, (work) disability and treatment adherence. Safety outcomes are drug-related and disease-related adverse events and disease progression on MRI-enterography at week 96.Ethics and disseminationThis study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 21 August 2019 (METC18-076) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.Trial registration numberNCT03917303.

Dataset Information

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial.

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