Dataset Information

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

ABSTRACT:

Introduction

Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19.

Methods and analysis

We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes.

Ethics and dissemination

The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies.

Trial registration

The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

SUBMITTER: Pearson M

PROVIDER: S-EPMC10276966 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

Pearson Melissa M Dawson Andrew A Raubenheimer Jacques J Senerathna Lalith L Conigrave Katherine K Lee K S Kylie KSK Rajapakse Thilini T Pushpakumara Pahala Hangidi Gedara Janaka PHGJ Siribaddana Sisira S Soerensen Jane Brandt JB Konradsen Flemming F Jan Stephen S Dawson Angela J AJ Buckley Nicholas N Abeysinghe Ranil R Siriwardhana Prabash P Priyadarshana Chamil C Haber Paul S PS Dzidowska Monika M Abeykoon Palitha P Glozier Nick N

BMJ open 20230615 6

<h4>Introduction</h4>Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19.<h4>Methods and analysis</h4>We aimed to recruit 2 ...[more]

PMID: 37321807

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Project description:BackgroundThe International Federation of Gynaecology and Obstetrics (FIGO), in collaboration with the Sri Lankan College of Obstetrics and Gynaecologists (SLCOG), launched an initiative in 2014 to institutionalize immediate postpartum IUD (PPIUD) services as a routine part of antenatal counseling and delivery room services in Sri Lanka. In this study, we evaluate the effect of the FIGO-SLCOG PPIUD intervention in six hospitals by means of a cluster-randomized stepped-wedge trial.Methods/designSix hospitals were randomized into two groups of three using matched pairs. Following a 3-month baseline period, the intervention was administered to the first group, while the second group received the intervention after 9 months of baseline data collection. We collected data from 39,084 women who delivered in these hospitals between September 2015 and January 2017. We conduct an intent-to-treat (ITT) analysis to determine the impact of the intervention on PPIUD counseling and choice of PPIUD, as measured by consent to receive a PPIUD, as well as PPIUD uptake (insertion following delivery). We also investigate how factors related to counseling, such as counseling timing and quality, are linked to choice of PPIUD.ResultsWe find that the intervention increased rates of counseling, from an average counseling rate of 12% in all hospitals prior to the intervention to an average rate of 51% in all hospitals after the rollout of the intervention (0.307; 95% CI 0.148-0.465). In contrast, we find the impact of the intervention on choice of PPIUD to be less robust and mixed, with 4.1% of women choosing PPIUD prior to the intervention compared to 9.8% of women choosing PPIUD after the rollout of the intervention (0.027; 95% CI 0.000-0.054).ConclusionsThis study demonstrates that incorporating PPIUD services into postpartum care is feasible and potentially effective. Taking the evidence on both counseling and choice of PPIUD together, we find that the intervention had a generally positive impact on receipt of PPIUD counseling and, to a lesser degree, on choice of the PPIUD. Nevertheless, it is clear that the intervention's effectiveness can be improved to be able to meet the demand for postpartum family planning of women.Trial registrationClinicalTrials.gov, NCT02718222 . Registered on 11 March 2016 (retrospectively registered).

Project description:Sri Lankan rural doctors based in isolated peripheral hospitals routinely resuscitate critically ill patients but have difficulty accessing training. We tested a train-the-trainer model that could be utilised in isolated rural hospitals.Eight selected rural hospital non-specialist doctors attended a 2-day instructor course. These "trained trainers" educated their colleagues in advanced cardiac life support at peripheral hospital workshops and we tested their students in resuscitation knowledge and skills pre and post training, and at 6- and 12-weeks. Knowledge was assessed through 30 multiple choice questions (MCQ), and resuscitation skills were assessed by performance in a video recorded simulated scenario of a cardiac arrest using a Resuci Anne Skill Trainer mannequin.Fifty seven doctors were trained. Pre and post training assessment was possible in 51 participants, and 6-week and 12-week follow up was possible for 43, and 38 participants respectively. Mean MCQ scores significantly improved over time (p<0.001), and a significant improvement was noted in "average ventilation volume", "compression count", and "compressions with no error", "adequate depth", "average depth", and "compression rate" (p<0.01). The proportion of participants with compression depth ?40mm increased post intervention (p<0.05) and at 12-week follow up (p<0.05), and proportion of ventilation volumes between 400-1000mls increased post intervention (p<0.001). A significant increase in the proportion of participants who "checked for responsiveness", "opened the airway", "performed a breathing check", who used the "correct compression ratio", and who used an "appropriate facemask technique" was also noted (p<0.001). A train-the-trainer model of resuscitation education was effective in improving resuscitation knowledge and skills in Sri Lankan rural peripheral hospital doctors. Improvement was sustained to 12 weeks for most components of resuscitation knowledge and skills. Further research is needed to identify which components of training are most effective in leading to sustained improvement in resuscitation.

Project description:IntroductionWhile tremendous progress has been made in recent years to improve the health of people living in low- and middle-income countries (LMIC), significant challenges remain. Chief among these are poor health systems, which are often ill-equipped to respond to current challenges. It remains unclear whether intensive intervention at the health system level will result in improved outcomes, as there have been few rigorously designed comparative studies. We present results of a complex health system intervention that was implemented in Zambia using a cluster randomized design.MethodsBHOMA was a complex health system intervention comprising intensive clinical training and quality improvement measures, support for commodities procurement, improved community outreach, and district level management support. The intervention was introduced as a stepped wedge cluster-randomized trial in 42 predominately rural health centers and their surrounding communities in Lusaka Province, Zambia. Baseline survey was conducted between January-May 2011, mid-line survey was conducted February-November, 2013 and Endline survey, February-November 2015.The primary outcome was all-cause mortality among those between 28 days and 60 years of age and assessed through community-based mortality surveys. Secondary outcomes included post-neonatal under-five mortality and service coverage scores. Service coverage scores were calculated across five domains (child preventative services; child treatment services; family planning; maternal health services, and adult health services). We fit Cox proportional hazards model with shared frailty at the cluster level for the primary analysis. Mortality rates were age-standardized using the WHO World Standard Population.ResultsMortality declined substantially from 3.9 per 1,000 person-years in the pre-intervention period, to 1.5 per 1,000 person-years in the post intervention period. When we compared intervention and control periods, there were 174 deaths in 49,230 person years (age-standardized rate = 4.4 per 1,000 person-years) in the control phase and 277 deaths in 74,519 person years (age-standardized rate = 4.6 per 1,000 person-years) in the intervention phase. Overall, there was no evidence for an effect of the intervention in minimally-adjusted [hazard ratio (HR) = 1.18; 95% confidence interval (CI): 0.88, 1.56; value of p = 0.265], or adjusted (HR = 1.12; 95% CI: 0.84, 1.49; value of p = 0.443) analyses.Coverage scores that showed some evidence of changing with time since the cluster joined the intervention were: an increasing proportion of children sleeping under insecticide treated bed-net (value of p < 0.001); an increasing proportion of febrile children who received appropriate anti-malarial drugs (value of p = 0.039); and an increasing proportion of ever hypertensive adults with currently controlled hypertension (value of p = 0.047). No adjustments were made for multiple-testing and the overall coverage score showed no statistical evidence for a change over time (value of p = 0.308).ConclusionWe noted an overall reduction in post-neonatal under 60 mortality in the study communities during the period of our study, but this could not be attributed to the BHOMA intervention. Some improvements in service coverage scores were observed.Clinical trial registrationclinicaltrials.gov, Identifier NCT01942278.

Dataset Information

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Publications

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

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