scholarly journals Effectiveness of a multi-component m-health-based intervention to decrease the consumption of discretionary foods packed in school lunchboxes: the ‘SWAP IT’ effectiveness-implementation hybrid type 1 trial. (Preprint)

10.2196/25256 ◽  
2020 ◽  
Author(s):  
Rachel Sutherland ◽  
Alison Brown ◽  
Nicole Nathan ◽  
Serene Yoong ◽  
Lisa Janssen ◽  
...  
Keyword(s):  
It Effectiveness ◽  
Hybrid Type

scholarly journals A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Andrian Liem ◽  
Melissa R. Garabiles ◽  
Karmia A. Pakingan ◽  
Wen Chen ◽  
Agnes Iok Fong Lam ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Health Intervention ◽  
Anxiety Symptoms ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Hybrid Type

Abstract Background The current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings. Methods This trial will follow an effectiveness-implementation hybrid type 1 trial design and utilize the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to accelerate the translation of clinical research into more effective implementation strategies and policies. Participants will be randomized 1:1 to control and treatment groups. Control group participants will receive ECAU that consists of brief depression psychoeducation and referral to local community partners. Treatment group participants will receive a 5-session of digital intervention through a mobile phone application. The primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing) will be measured using validated instruments. To evaluate study implementation, an embedded mixed-methods design will be used to collect data from various stakeholders. Data then will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline. Discussion This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability. If SbS-F shows positive results among OFWs in Macao, it has strong potential to be used by OFWs in other countries that may also experience depression and difficulty accessing mental health services. Trial registration Prospective registration, Chinese Clinical Trial Registry (ChiCTR2000034959) on 26/07/2020.

scholarly journals Trauma Communications Center Coordinated Severity-Based Stroke Triage: Protocol of a Hybrid Type 1 Effectiveness-Implementation Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Toby I. Gropen ◽  
Nataliya V. Ivankova ◽  
Mark Beasley ◽  
Erik P. Hess ◽  
Brian Mittman ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Care Pathway ◽  
Trauma System ◽  
Stroke Severity ◽  
Implementation Study ◽  
Stakeholder Perceptions ◽  
Hybrid Type ◽  
Before And After ◽  
Timely Access

Background: Mechanical thrombectomy (MT) can improve the outcomes of patients with large vessel occlusion (LVO), but a minority of patients with LVO are treated and there are disparities in timely access to MT. In part, this is because in most regions, including Alabama, the emergency medical service (EMS) transports all patients with suspected stroke, regardless of severity, to the nearest stroke center. Consequently, patients with LVO may experience delayed arrival at stroke centers with MT capability and worse outcomes. Alabama's trauma communications center (TCC) coordinates EMS transport of trauma patients by trauma severity and regional hospital capability. Our aims are to develop a severity-based stroke triage (SBST) care model based on Alabama's trauma system, compare the effectiveness of this care pathway to current stroke triage in Alabama for improving broad, equitable, and timely access to MT, and explore stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability.Methods: This is a hybrid type 1 effectiveness-implementation study with a multi-phase mixed methods sequential design and an embedded observational stepped wedge cluster trial. We will extend TCC guided stroke severity assessment to all EMS regions in Alabama; conduct stakeholder interviews and focus groups to aid in development of region and hospital specific prehospital and inter-facility stroke triage plans for patients with suspected LVO; implement a phased rollout of TCC Coordinated SBST across Alabama's six EMS regions; and conduct stakeholder surveys and interviews to assess context-specific perceptions of the intervention. The primary outcome is the change in proportion of prehospital stroke system patients with suspected LVO who are treated with MT before and after implementation of TCC Coordinated SBST. Secondary outcomes include change in broad public health impact before and after implementation and stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability using a mixed methods approach. With 1200 to 1300 total observations over 36 months, we have 80% power to detect a 15% improvement in the primary endpoint.Discussion: This project, if successful, can demonstrate how the trauma system infrastructure can serve as the basis for a more integrated and effective system of emergency stroke care.

scholarly journals Harnessing single-session interventions to improve adolescent mental health and well-being in India: Development, adaptation, and pilot testing of online single-session interventions in Indian secondary schools

2019 ◽  
Author(s):  
Akash Wasil ◽  
Suh Jung Park ◽  
Sarah Gillespie ◽  
Rebecca Shingleton ◽  
Sachin Shinde ◽  
...  
Keyword(s):  
Mental Health ◽  
Focus Groups ◽  
Controlled Trial ◽  
Well Being ◽  
Evidence Based ◽  
Implementation Study ◽  
Single Session ◽  
Implementation Barriers ◽  
Hybrid Type

Background: Many evidence-based prevention and intervention approaches for youth mental health exist, but most are time-consuming and expensive to deliver. Innovative approaches are needed to develop and disseminate scalable mental health interventions, especially for youth in low- and middle-income countries. Computerized single-session interventions (SSIs) may be able to overcome many of these implementation barriers, especially if deployed in school settings. Methods: Guided by this logic, we designed three computerized SSIs (based on behavioral activation, gratitude, and growth mindset exercises) for delivery in Indian high schools. Then, we conducted focus groups with Indian adolescents and school officials to inform adaptations of the interventions. Finally, we designed a Hybrid Type 1 effectiveness-implementation study to evaluate the interventions. Results: In this paper, we present the rationale for selecting the interventions, the results of the focus groups, and the design of a Hybrid Type 1 effectiveness-implementation study. Our initial focus group data showed that the interventions were considered acceptable, feasible, and appropriate by both educators and students. We also describe feedback on the interventions which we incorporated to refine the interventions prior to our randomized controlled trial. Discussion: Computerized SSIs may offer innovative, scalable ways to disseminate evidence-based interventions. By identifying which interventions are most acceptable and effective in this highly scalable format, we may understand which SSIs are best suited for continued development, testing, and, ultimately, widespread dissemination.

scholarly journals Reflections on a successful hybrid type 1 diabetes summer camp in China during the COVID‐19 pandemic

2022 ◽  
Author(s):  
Wei Liu ◽  
Xiaoling Cai ◽  
Yu Zhu ◽  
Mingxia Zhang ◽  
Juan Li ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Summer Camp ◽  
Hybrid Type

scholarly journals Implementation outcomes and strategies for depression interventions in low- and middle-income countries: a systematic review

2020 ◽  
Vol 7 ◽  
Author(s):  
Bradley H. Wagenaar ◽  
Wilson H. Hammett ◽  
Courtney Jackson ◽  
Dana L. Atkins ◽  
Jennifer M. Belus ◽  
...  
Keyword(s):  
Early Stage ◽  
Scale Up ◽  
Sub Saharan Africa ◽  
Future Research ◽  
Middle Income ◽  
Middle Income Countries ◽  
Hybrid Type ◽  
Implementation Outcomes ◽  
Low And Middle Income

Abstract Background We systematically reviewed implementation research targeting depression interventions in low- and middle-income countries (LMICs) to assess gaps in methodological coverage. Methods PubMed, CINAHL, PsycINFO, and EMBASE were searched for evaluations of depression interventions in LMICs reporting at least one implementation outcome published through March 2019. Results A total of 8714 studies were screened, 759 were assessed for eligibility, and 79 studies met inclusion criteria. Common implementation outcomes reported were acceptability (n = 50; 63.3%), feasibility (n = 28; 35.4%), and fidelity (n = 18; 22.8%). Only four studies (5.1%) reported adoption or penetration, and three (3.8%) reported sustainability. The Sub-Saharan Africa region (n = 29; 36.7%) had the most studies. The majority of studies (n = 59; 74.7%) reported outcomes for a depression intervention implemented in pilot researcher-controlled settings. Studies commonly focused on Hybrid Type-1 effectiveness-implementation designs (n = 53; 67.1), followed by Hybrid Type-3 (n = 16; 20.3%). Only 21 studies (26.6%) tested an implementation strategy, with the most common being revising professional roles (n = 10; 47.6%). The most common intervention modality was individual psychotherapy (n = 30; 38.0%). Common study designs were mixed methods (n = 27; 34.2%), quasi-experimental uncontrolled pre-post (n = 17; 21.5%), and individual randomized trials (n = 16; 20.3). Conclusions Existing research has focused on early-stage implementation outcomes. Most studies have utilized Hybrid Type-1 designs, with the primary aim to test intervention effectiveness delivered in researcher-controlled settings. Future research should focus on testing and optimizing implementation strategies to promote scale-up of evidence-based depression interventions in routine care. These studies should use high-quality pragmatic designs and focus on later-stage implementation outcomes such as cost, penetration, and sustainability.

scholarly journals OnTrack Chile for People With Early Psychosis: a Study Protocol for a Hybrid Type 1 Trial

2021 ◽  
Author(s):  
Franco Mascayano ◽  
Iruma Bello ◽  
Howard Andrews ◽  
Diego Arancibia ◽  
Tamara Arratia ◽  
...  
Keyword(s):  
Latin American ◽  
Universal Access ◽  
Implementation Fidelity ◽  
Lessons Learned ◽  
Public Health Care ◽  
Outpatient Clinics ◽  
Evidence Based ◽  
Hybrid Type ◽  
Recovery Orientation

Abstract Background: Substantial data from high-income countries support early interventions in the form of evidence-based Coordinated Specialty Care (CSC) for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. Chile is unique among Latin American countries in providing universal access to FEP services through a national FEP policy that mandates identification of FEP individuals in primary care and guarantees delivery of community-based FEP treatments within a public health care system. Nonetheless, previous research has documented that FEP services currently provided at mental health clinics do not provide evidence-based approaches. This proposal aims to address this shortfall by first adapting OnTrackNY (OTNY), a CSC program currently being implemented across the US, into OnTrackChile (OTCH), and then examine its effectiveness and implementation in Chile.Methods: The Dynamic Adaptation Process will be used first to inform the adaptation and implementation of OTCH to the Chilean context. Then, a Hybrid Type 1 Trial design will test its effectiveness and cost and evaluate its implementation using a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OTCH program will be offered in half of these outpatient clinics to individuals ages 15-35. Usual care services will continue to be offered at the other clinics. Given the current COVID-19 pandemic, most research and intervention procedures will be conducted remotely. The study will engage participants over the course of two years, with assessments administered at enrollment, 12 months and 24 months. Primary outcomes include: implementation (fidelity, acceptability, and uptake) and service outcomes (person-centeredness, adherence, and retention). Secondary outcomes comprise participant-level outcomes such as symptoms, functioning, and recovery orientation. Over the course of the study, interviews and focus groups with stakeholders will be conducted to better understand the implementation of OTCH. Discussion: Findings from this study will help determine the feasibility, effectiveness, and cost for delivering CSC services in Chile. Lessons learned about facilitators and barriers related to the implementation of the model could help inform the approach needed for these services to be further expanded throughout Latin America.Trial registration number: www.clinicaltrials.gov: NCT04247711. Registered 30 January 2020, https://clinicaltrials.gov/ct2/show/NCT04247711.

scholarly journals Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial

2021 ◽  
Vol 5 (1) ◽  
pp. e001254
Author(s):  
Abhishek Raut ◽  
Revan Mustafayev ◽  
Roopa Srinivasan ◽  
Anita Chary ◽  
Ilgi Ertem ◽  
...  
Keyword(s):  
Child Development ◽  
Usual Care ◽  
Low Income ◽  
Controlled Trial ◽  
Care Home ◽  
Developmental Potential ◽  
Hybrid Type ◽  
Cluster Randomised ◽  
Open Access Journals

IntroductionMore than 40% of children under 5 years of age in low-income and middle-income countries are at risk of not reaching their developmental potential. The international Guide for Monitoring Child Development (GMCD) early intervention package is a comprehensive programme to address developmental difficulties using an individualised intervention plan for young children and their families. We will conduct a hybrid type 1 effectiveness–implementation evaluation of the GMCD intervention in rural India and Guatemala.Methods and analysisUsing a cluster-randomised design, 624 children aged 0–24 months in 52 clusters (26 in India, 26 in Guatemala) will be assigned to usual care or the GMCD intervention plus usual care delivered by frontline workers for 12 months. After 12 months, the usual care arm will cross over to the intervention, which will continue for 12 additional months (24 total). The intervention will be delivered using a digital mobile device interface. Effectiveness will be assessed for developmental functioning (Bayley Scales of Infant Development, 3rd edition) and nurturing care (Home Observation for Measurement of the Environment Scale) outcomes. Implementation will be assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. Explanatory qualitative analysis guided by the Consolidated Framework for Implementation Research will explore determinants between clusters with high versus low implementation effectiveness.Ethics and disseminationThe study has been approved by the Institutional Review Boards of Brigham and Women’s Hospital, Mahatma Gandhi Institute of Medical Sciences and Maya Health Alliance; and by the Indian Council of Medical Research/Health Ministry Screening Committee. Key study findings will be published in international open-access journals.Trial registration numberNCT04665297, CTRI/2020/12/029748.Protocol version1.0 (12 November 2020).

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