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Background: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. Objectives: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. Methods: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. Discussion: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. Conclusions: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. Trial registration: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570 [ABSTRACT FROM AUTHOR]

Background: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. Methods: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. Results: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. Conclusions: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation. Trial registration: The original trial was prospectively registered with ClinicalTrials.gov (NCT04417127) on 4 June 2020. [ABSTRACT FROM AUTHOR]

Background: Health and social service providers receive limited education on recognizing and responding to family violence. With adequate education, providers could be prepared to identify individuals subjected to family violence and help reduce the risk of associated impairment. Informed by the Active Implementation Frameworks, our research will determine the scope of strategies needed for the uptake and sustainability of educational interventions focused on family violence for providers. It will also determine the acceptability, feasibility, and proof-of-concept for a new educational intervention, called VEGA (Violence, Evidence, Guidance, Action), for developing and improving primary care provider knowledge and skills in family violence. Methods: This paper details the protocol for the Researching the Impact of Service provider Education (RISE) Project. The RISE Project follows a sequential multiphase mixed method research design; qualitative and quantitative data are being collected and integrated over three conceptually and methodologically linked research phases. Activities primarily occur in Ontario, Alberta, and Quebec. Phase 1 uses a sequential exploratory mixed method research design to characterize the scope and salience of learning and implementation needs and preferences for family violence education. Phase 2 will use an embedded mixed method research design to determine whether VEGA technology supports providers to achieve their family violence learning goals with effectiveness, efficiency, and satisfaction. Phase 3 will use a concurrent mixed method research design to determine acceptability, feasibility, and proof-of-concept for evaluating whether VEGA improves primary care providers' knowledge and skills in family violence. This final phase will provide information on implementation strategies for family violence education in the "real world." It will also generate data on provider recruitment, retention, and data completeness, as well as exploratory estimates of the effect for provider outcome measures proposed for a randomized controlled trial. Discussion: The RISE Project comprehensively integrates an implementation approach to improve family violence education for the health and social service professions. It will provide important information about factors that could influence the uptake and effectiveness of a health profession's educational intervention into the real world, as well as provide foundational evidence concerning the tenability of using a randomized controlled trial to evaluate the impact of VEGA in primary care settings. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50–60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment. Methods: This is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant's having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention. Discussion: This pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA. Trial registration: ClinicalTrials.gov NCT04488497. Registered on July 28, 2020. [ABSTRACT FROM AUTHOR]

Background: Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study. Methods: This is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14 years of age (pregnant or with a newborn < 2 months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2 months postpartum), and 2, 6, and 12 months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes. Discussion: This trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting. Trial registration: ClinicalTrials.gov #NCT03975530; Registered on June 5, 2019 [ABSTRACT FROM AUTHOR]

Background: Effective translation of evidence-based research into clinical practice requires assessment of the many factors that can impact implementation success. Research methods that draw on recognised implementation frameworks, such as the Promoting Action Research in Health Services (PARiHS) framework, and that test feasibility to gain information prior to full-scale roll-out, can support a more structured approach to implementation. Objective: This paper presents qualitative findings from a feasibility study in one cancer service of an online portal to operationalise a clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients. The aim of this study was to explore staff perspectives on the feasibility and acceptance of a range of strategies to support implementation in order to inform the full-scale roll-out. Methods: Semi-structured interviews were conducted with fifteen hospital staff holding a range of clinical, administrative and managerial roles, and with differing levels of exposure to the pathway. Qualitative data were analysed thematically, and themes were subsequently organised within the constructs of the PARiHS framework. Results: Barriers and facilitators that affected the feasibility of the online portal and implementation strategies were organised across eight key themes: staff perceptions, culture, external influences, attitudes to psychosocial care, intervention fit, familiarity, burden and engagement. These themes mapped to the PARiHS framework's three domains of evidence, context and facilitation. Conclusions: Implementation success may be threatened by a range of factors related to the real-world context, perceptions of the intervention (evidence) and the process by which it is introduced (facilitation). Feasibility testing of implementation strategies can provide unique insights into issues likely to influence full-scale implementation, allowing for early tailoring and more effective facilitation which may save time, money and effort in the long-term. Use of a determinant implementation framework can assist researchers to synthesise and effectively respond to barriers as they arise. While the current feasibility study related to a specific implementation, strategies such as regular engagement with local stakeholders, and discussion of barriers arising in real-time during early testing is likely to be of benefit to all researchers and clinicians seeking to maximise the likelihood of long-term implementation success. [ABSTRACT FROM AUTHOR]

Background: Pancreatic cancer has one of the highest mortality rates of any malignancy, placing a substantial burden on patients and families with high unmet informational and supportive care needs. Nevertheless, access to psychosocial and palliative care services for the individuals affected is limited. There is a need for standardized approaches to facilitate adjustment and to improve knowledge about the disease and its anticipated impact. In this intervention-development paper guided by implementation science principles, we report the rationale, methods, and processes employed in developing an interdisciplinary group psychoeducational intervention for people affected by pancreatic cancer. The acceptability and feasibility of implementation will be evaluated as a part of a subsequent feasibility study. Methods: The Schofield and Chambers framework for designing sustainable self-management interventions in cancer care informed the development of the intervention content and format. The Consolidated Framework for Implementation Research served as an overarching guide of the implementation process, including the development phase and the formative evaluation plan of implementation. Results: A representative team of stakeholders collaboratively developed and tailored the intervention content and format with attention to the principles of implementation science, including available resourcing. The final intervention prototype was designed as a single group-session led by an interdisciplinary clinical team with expertise in caring for patients with pancreatic cancer and their families and in addressing nutrition guidelines, disease and symptom management, communication with family and health care providers, family impact of cancer, preparing for the future, and palliative and supportive care services. Conclusions: The present paper describes the development of a group psychoeducational intervention to address the informational and supportive care needs of people affected by pancreatic cancer. Consideration of implementation science during intervention development efforts can optimize uptake and sustainability in the clinical setting. Our approach may be utilized as a framework for the design and implementation of similar initiatives to support people affected by diseases with limited prognoses. [ABSTRACT FROM AUTHOR]

Background: Adoption of responsive trauma-informed practices by staff in hospital-based paediatric care may help mitigate downstream costs associated with treatment delivery due to reduced pain and distress for children and care providers, improved health-related quality of life and increased satisfaction with care. A web-based education intervention (termed Responsive CARE) was developed to build self-efficacy of staff in a paediatric medical setting. This protocol paper describes a feasibility study (including preliminary effectiveness) of the implementation of Responsive CARE in a tertiary, outpatient burn clinical setting. Methods: A pre-post, mixed methods design will be employed. Children and caregivers attending hospital for change of burn wound dressings or burn scar management during the 3-month control or 3-month intervention period will be eligible, with follow-up to 6-months post-baseline. All children and caregiver/s will receive "standard care" including burn interventions focused on wound healing, scar management, itch management (both pharmacological and non-pharmacological), counselling, age-appropriate procedural support and burn rehabilitation. Health professional participants will be those involved in the management of children with burns during the study period or their senior managers. Health professional participants who attend a weekly educational clinical meeting will be invited to complete the intervention during a 1-month timeframe between the control and intervention period (or upon their commencement in burn outpatients during the intervention period) using an individualised log-in process. A purposive sample of caregivers and health professionals will be sought for participation in semi-structured interviews. Qualitative data will be analysed using Framework analysis. Feasibility will be evaluated via interviews, digital records of intervention usage and technical assistance logs. The primary outcome measures of effectiveness (pain, itch and distress) will be measured using self-report or behavioural observation. Quantitative data will primarily be analysed descriptively and using generalised linear models. Discussion: This study will provide insights into factors that impact upon the feasibility of a web-based trauma-informed care education intervention in a clinical practice setting. This knowledge may support other education approaches within healthcare settings related to improving and supporting patients to reduce the risk of healthcare interactions that result in paediatric medical traumatic stress. [ABSTRACT FROM AUTHOR]