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Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

ABSTRACT: INTRODUCTION:Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term. METHODS AND ANALYSIS:Our design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania's Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance. ETHICS AND DISSEMINATION:The study has received ethical approval from Harvard Medical School and Tanzania's National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania's Lake Zone region and other similar contexts.

SUBMITTER: Alidina S

PROVIDER: S-EPMC6797473 | biostudies-other | 2019 Oct

REPOSITORIES: biostudies-other

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Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

Alidina Shehnaz S Kuchukhidze Salome S Menon Gopal G Citron Isabelle I Lama Tenzing N TN Meara John J Barash David D Hellar Augustino A Kapologwe Ntuli A NA Maina Erastus E Reynolds Cheri C Staffa Steven J SJ Troxel Alena A Varghese Asha A Zurakowski David D Ulisubisya Mpoki M Maongezi Sarah S

BMJ open 20191007 10

<h4>Introduction</h4>Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quali ...[more]

PMID: 31594896

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Project description:Evidence-based strategies for improving surgical quality and patient outcomes in low-resource settings are a priority. To evaluate the impact of a multicomponent safe surgery intervention (Safe Surgery 2020) on (1) adherence to safety practices, teamwork and communication, and documentation in patient files, and (2) incidence of maternal sepsis, postoperative sepsis, and surgical site infection. We conducted a prospective, longitudinal study in 10 intervention and 10 control facilities in Tanzania's Lake Zone, across a 3-month pre-intervention period in 2018 and 3-month post-intervention period in 2019. SS2020 is a multicomponent intervention to support four surgical quality areas: (i) leadership and teamwork, (ii) evidence-based surgery, anesthesia and equipment sterilization practices, (iii) data completeness and (iv) infrastructure. Surgical team members received training and mentorship, and each facility received up to a $10 000 infrastructure grant. Inpatients undergoing major surgery and postpartum women were followed during their stay up to 30 days. We assessed adherence to 14 safety and teamwork and communication measures through direct observation in the operating room. We identified maternal sepsis (vaginal or cesarean delivery), postoperative sepsis and SSIs prospectively through daily surveillance and assessed medical record completeness retrospectively through chart review. We compared changes in surgical quality outcomes between intervention and control facilities using difference-in-differences analyses to determine areas of impact. Safety practices improved significantly by an additional 20.5% (95% confidence interval (CI), 7.2-33.7%; P = 0.003) and teamwork and communication conversations by 33.3% (95% CI, 5.7-60.8%; P = 0.02) in intervention facilities compared to control facilities. Maternal sepsis rates reduced significantly by 1% (95% CI, 0.1-1.9%; P = 0.02). Documentation completeness improved by 41.8% (95% CI, 27.4-56.1%; P < 0.001) for sepsis and 22.3% (95% CI, 4.7-39.8%; P = 0.01) for SSIs. Our findings demonstrate the benefit of the SS2020 approach. Improvement was observed in adherence to safety practices, teamwork and communication, and data quality, and there was a reduction in maternal sepsis rates. Our results support the emerging evidence that improving surgical quality in a low-resource setting requires a focus on the surgical system and culture. Investigation in diverse contexts is necessary to confirm and generalize our results and to understand how to adapt the intervention for different settings. Further work is also necessary to assess the long-term effect and sustainability of such interventions.

Project description:BackgroundSafe, high-quality surgical care in many African countries is a critical need. Challenges include availability of surgical providers, improving quality of care, and building workforce capacity. Despite growing evidence that mentoring is effective in African healthcare settings, less is known about its role in surgery. We examined a multimodal approach to mentorship as part of a safe surgery intervention (Safe Surgery 2020) to improve surgical quality. Our goal was to distill lessons for policy makers, intervention designers, and practitioners on key elements of a successful surgical mentorship program.MethodsWe used a convergent, mixed-methods design to examine the experiences of mentees, mentors, and facility leaders with mentorship at 10 health facilities in Tanzania's Lake Zone. A multidisciplinary team of mentors worked with surgical providers over 17 months using in-person mentorship, telementoring, and WhatsApp. We conducted surveys, in-depth interviews, and focus groups to capture data in four categories: (1) satisfaction with mentorship; (2) perceived impact; (3) elements of a successful mentoring program; and (4) challenges to implementing mentorship. We analyzed quantitative data using frequency analysis and qualitative data using the constant comparison method. Recurrent and unifying concepts were identified through merging the qualitative and quantitative data.ResultsOverall, 96% of mentees experienced the intervention as positive, 88% were satisfied, and 100% supported continuing the intervention in the future. Mentees, mentors, and facility leaders perceived improvements in surgical practice, the surgical ecosystem, and in reducing postsurgical infections. Several themes related to the intervention's success emerged: (1) the intervention's design, including its multimodality, side-by-side mentorship, and standardization of practices; (2) the mentee-mentor relationship, including a friendly, safe, non-hierarchical, team relationship, as well as mentors' understanding of the local context; and (3) mentorship characteristics, including non-judgmental feedback, experience, and accessibility. Challenges included resistance to change, shortage of providers, mentorship dose, and logistics.ConclusionsOur study suggests a multimodal mentorship approach is promising in building the capacity of surgical providers. By distilling the experiences of the mentees, mentors, and facility leaders, our lessons provide a foundation for future efforts to establish effective surgical mentorship programs that build provider capacity and ultimately improve surgical quality.

Project description:BackgroundThe SingHypertension primary care clinic intervention, which consisted of clinician training in hypertension management, subsidized single-pill combination medications, nurse-delivered motivational conversations and telephone follow-ups, improved blood pressure control and cardiovascular disease (CVD) risk scores relative to usual care among patients with uncontrolled hypertension in Singapore. This study quantified the incremental cost-effectiveness, in terms of incremental cost per unit reduction disability-adjusted life years, of SingHypertension relative to usual care for patients with hypertension from the health system perspective.Methods and resultsWe developed a Markov model to simulate CVD events and associated outcomes for a hypothetical cohort of patients over a 10-year period. Costs were measured in US dollars, and effectiveness was measured in disability-adjusted life years averted. We present base-case results and conducted deterministic and probabilistic sensitivity analyses. Based on a willingness-to-pay threshold of US $55 500 per DALY averted, SingHypertension was cost-effective for patients with hypertension (incremental cost-effectiveness ratio: US $24 765 per disability-adjusted life year averted) relative to usual care. This result held even if risk reduction was assumed to decline linearly to 0 over 10 years but not sooner than 7 years. Incremental cost-effectiveness ratios were most sensitive to the magnitude of the reduction in CVD risk; at least a 0.13% to 0.16% point reduction in 10-year CVD risk is required for cost-effectiveness. Probabilistic sensitivity analysis indicates that SingHypertension has a 78% chance of being cost-effective at the willingness-to-pay threshold.ConclusionsSingHypertension represents good value for the money for reducing CVD incidence, morbidity, and mortality and should be considered for wide-scale implementation in Singapore and possibly other countries.Registration informationREGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02972619.

Project description:In light of the high prevalence of childhood overweight and obesity, there is a need of developing effective prevention programs to address the rising prevalence and the concomitant health consequences. The main aim of the present study is to systematically develop and implement a tailored family-based intervention for improving lifestyle habits among overweight and obese children, aged 6-10 years old, enhancing parental self-efficacy, family engagement and parent-child interaction. A subsidiary aim of the intervention study is to reduce the prevalence of overweight and obesity among those participating in the intervention study.The Intervention Mapping protocol was used to develop a tailored family-based intervention for improving lifestyle habits among overweight and obese children. In order to gather information on local opportunities and barriers, interviews with key stakeholders and a 1-year pilot study was conducted. The main study has used a quasi-experimental controlled design. Locally based Healthy Life Centers and Public Health Clinics are responsible for recruiting families and conducting the intervention. The effect of the study will be measured both at completion of the 6 months intervention study and 6 and 18 months after the intervention period. An ecological approach was used as a basis for developing the intervention. The behavioral models and educational strategies include individual family counselling meetings, workshops focusing on regulation of family life, nutrition courses, and physical activity groups providing tailored information and practical learning sessions. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors.A systematic and evidence-based approach was used for development of this family-based intervention study targeting overweight and obese children, 6-10 years old. This program, if feasible and effective, may be adjusted to local contexts and implemented in all municipal health care institutions in Norway.NCT02247219 . Prospectively registered on October 26, 2014.

Project description:INTRODUCTION:This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months' follow-up. METHODS AND ANALYSIS:Pragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ?70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients' sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level. ETHICS AND DISSEMINATION:The study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients' autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal. TRIAL REGISTRATION NUMBER:ISRCTN17143761.

Project description:BackgroundSystemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE).MethodsThe study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned.DiscussionImpact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting.Trial registrationClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Project description:BackgroundDementia is a leading cause of death and disability that was declared as one of the greatest health and social care challenges of the twenty-first century. Regular physical activity and exercise have been proposed as a non-pharmacological strategy in disease prevention and management. Multicomponent Training (MT) combines aerobic, strength, balance and postural exercises and might be an effective training to improve both functional capacity and cognitive function in individuals with dementia (IwD). Nevertheless, data on the effects of MT in IwD are still limited and the extent to which IwD can retain improvements after an exercise intervention still needs to be elucidated. The aim of "Body & Brain" study is to investigate the effects of a 6-month MT intervention and 3-month detraining on the physical and cognitive function of IwD. Additionally, we aim to explore the impact of this intervention on psychosocial factors and physiologic markers related to dementia.MethodsThis study is a quasi-experimental controlled trial using a parallel-group design. The study sample consists of community-dwelling individuals aged ≥60 years who are clinically diagnosed with dementia or major neurocognitive disorder. Participants will be either allocated into the intervention group or the control group. The intervention group will participate in MT biweekly exercise sessions, whereas the control group will receive monthly sessions regarding physical activity and health-related topics for 6 months. The main outcomes will be physical function as measured by the Short Physical Performance Battery (SPPB) and cognitive function evaluated using the Alzheimer Disease Assessment Scale - Cognitive (ADAS-Cog) at baseline, after 6-months and 3-months after the end of intervention. Secondary outcomes will be body composition, physical fitness, daily functionality, quality of life, neuropsychiatric symptoms and caregiver's burden. Cardiovascular, inflammatory and neurotrophic blood-based biomarkers, and arterial stiffness will also be evaluated in subsamples.DiscussionIf our hypothesis is correct, this project will provide evidence regarding the efficacy of MT training in improving physical and cognitive function and give insights about its impact on novel molecular biomarkers related to dementia. This project may also contribute to provide guidelines on exercise prescription for IwD.Trial registrationClinicalTrials.gov - identifier number NCT04095962 ; retrospectively registered on 19 September 2019.

Project description:Background: Suicide remains an important cause of premature deaths and draws much media attention. However, unsafe reporting and portrayal of suicides by the media have been associated with increased risk of suicidal behavior. Current evidence suggests that media capacity-building could potentially prevent suicide. However, there are still knowledge gaps in terms of a lack of data on effective strategies for improving awareness and safe reporting of suicide-related media content. This study aims to investigate the effectiveness of a workshop conducted with members of the media community on the safe reporting of suicide-related content. Methods: An interventional single-arm pre and post pilot study was conducted on a sample of the Malaysian media community recruited through purposive and snowball sampling. The media safe reporting workshop was conducted by a suicide prevention expert with a media industry background. Thirty participants completed a self-reported evaluation questionnaire on their awareness and knowledge of reporting on suicide-related media content; before and after the interventional workshop. Results: There was a significant difference between the total scores before and after the intervention, with a large effect size. Post-intervention scores were significantly improved in 8 items, namely those related to the reporting of: (i) the content of any suicide note; (ii) headlines with methods of suicide; (iii) headlines with the location of suicide; (iv) cases of suspected suicide despite the unconfirmed cause of death; (v) suicide news to cater to readers' interests; (vi) cause of suicide; (vii) details of the location of suicide; and (viii) the negative impact to media community when reporting suicide stories. In particular, there was an improvement in the majority of items for people from the media community with no lived experience of suicidal behavior. Conclusion: The media safe reporting workshop is a potentially effective intervention for improving awareness and knowledge measures relating to safe reporting on suicide among the media community, with a more pronounced effect in those without lived experience of suicidal behavior. Limitations in the sample size, generalizability, short-term evaluation, and lack of a control group warrant future larger, longer-term controlled, and more representative studies.

Dataset Information

Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

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Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

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