Dataset Information

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

ABSTRACT:

Background

Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.

Methods

Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study.

Discussion

This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing.

Trial registration

ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1.

SUBMITTER: Aschbrenner KA

PROVIDER: S-EPMC10047804 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

Aschbrenner Kelly A KA Pratt Sarah I SI Bond Gary R GR Zubkoff Lisa L Naslund John A JA Jue Kenneth K Williams Gail G Kinney Allison A Cohen Michael J MJ Godfrey Marjorie M MM Bartels Stephen J SJ

Contemporary clinical trials 20190722

<h4>Background</h4>Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.<h4>Methods</h4>Forty-eight mental ...[more]

PMID: 31344520

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Project description:BackgroundVirtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.MethodsUsing Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor's Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15-27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.DiscussionThis study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.Trial registrationClinicaltrials.gov . NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1.

Project description:BackgroundWomen ages 16-29 utilizing family planning clinics for medical services experience higher rates of intimate partner violence (IPV) and reproductive coercion (RC) than their same-age peers, increasing risk for unintended pregnancy and related poor reproductive health outcomes. Brief interventions integrated into routine family planning care have shown promise in reducing risk for RC, but longer-term intervention effects on partner violence victimization, RC, and unintended pregnancy have not been examined.Methods/designThe 'Addressing Reproductive Coercion in Health Settings (ARCHES)' Intervention Study is a cluster randomized controlled trial evaluating the effectiveness of a brief, clinician-delivered universal education and counseling intervention to reduce IPV, RC and unintended pregnancy compared to standard-of-care in family planning clinic settings. The ARCHES intervention was refined based on formative research. Twenty five family planning clinics were randomized (in 17 clusters) to either a three hour training for all family planning clinic staff on how to deliver the ARCHES intervention or to a standard-of-care control condition. All women ages 16-29 seeking care in these family planning clinics were eligible to participate. Consenting clients use laptop computers to answer survey questions immediately prior to their clinic visit, a brief exit survey immediately after the clinic visit, a first follow up survey 12-20 weeks after the baseline visit (T2), and a final survey 12 months after the baseline (T3). Medical record chart review provides additional data about IPV and RC assessment and disclosure, sexual and reproductive health diagnoses, and health care utilization. Of 4009 women approached and determined to be eligible based on age (16-29 years old), 3687 (92 % participation) completed the baseline survey and were included in the sample.DiscussionThe ARCHES Intervention Study is a community-partnered study designed to provide arigorous assessment of the short (3-4 months) and long-term (12 months) effects of a brief, clinician-delivered universal education and counseling intervention to reduce IPC, RC and unintended pregnancy in family planning clinic settings. The trial features a cluster randomized controlled trial design, a comprehensive data collection schedule and a large sample size with excellent retention.Trial registrationClinicialTrials.gov NCT01459458. Registered 10 October 2011.

Project description:BackgroundChronic diseases like diabetes, cardiovascular diseases and cancers are on the rise. Most of the risk factors of these diseases commence in Adolescence. Therefore, a cluster randomised controlled trial is designed to evaluate the effect of school-based health promotion intervention on the risk factors of chronic diseases.MethodologyConsidering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India. After baseline assessment, six schools will be randomly allocated to intervention and six to the control arm. Study participants will be students of 8th grade (age 10-16 years), their parents and teachers. A sample of 360 students (12 clusters x 30 students) has been estimated to provide statistically valid inference. The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions will be implemented for six-months in the school setting. For students, the intervention will comprise interactive learning sessions of 30 minutes duration per week and physical activity sessions of 30 minutes duration four times every week. Educational sessions will be conducted for parents and teachers for 30 minutes, four times during the intervention period. Primary outcomes will be changes in the prevalence of behavioural risk factors from pre- to post-intervention. Changes in anthropometric, physiological, and biochemical measures will be the secondary outcomes. The difference-in-difference (DID) method will be used to measure the net change in the outcomes.DiscussionIt is essential to understand whether health promotion interventions implemented in the school setting simultaneously targeting adolescents, teachers, and parents are effective. Using the PRECEDE-PROCEED model for planning, implementing, and evaluating the intervention as part of a cluster Randomized Controlled Trial design with DID analysis, could objectively assess the impact.

Project description:BackgroundWell-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia.MethodsEach intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation.ConclusionsAt present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace.Trial registrationPlease refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022.

Project description:BACKGROUND:The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery. METHODS:BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors. DISCUSSION:The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts. TRIAL REGISTRATION:Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://clinicaltrials.gov/ct2/show/NCT03243396.

Project description:IntroductionWith mental ill health listed as a top cause of global disease burden, there is an urgent need to prioritise mental health promotion programmes. Mindfulness-based programmes (MBPs) are being widely implemented to reduce stress in non-clinical settings. In a recent aggregate-level meta-analysis we found that, compared with no intervention, these MBPs reduce average psychological distress. However, heterogeneity between studies impedes generalisation of effects across every setting. Study-level effect modifiers were insufficient to reduce heterogeneity; studying individual-level effect modifiers is warranted. This requires individual participant data (IPD) and larger samples than those found in existing individual trials.Methods and analysisWe propose an IPD meta-analysis. Our primary aim is to see if, and how, baseline psychological distress, gender, age, education and dispositional mindfulness moderate the effect of MBPs on distress. We will search 13 databases for good-quality randomised controlled trials comparing in-person, expert-defined MBPs in non-clinical settings with passive controls. Two researchers will independently select, extract and appraise trials using the revised Cochrane risk-of-bias tool. Anonymised IPD of eligible trials will be sought from authors, who will be invited to collaborate.The primary outcome will be psychological distress measured using psychometrically validated questionnaires at 1-6 months after programme completion. Pairwise random-effects two-stage IPD meta-analyses will be conducted. Moderator analyses will follow a 'deft' approach. We will estimate subgroup-specific intervention effects. Secondary outcomes and sensitivity analyses are prespecified. Multiple imputation strategies will be applied to missing data.Ethics and disseminationThe findings will refine our knowledge on the effectiveness of MBPs and help improve the targeting of MBPs in non-clinical settings. They will be shared in accessible formats with a range of stakeholders. Public and professional stakeholders are being involved in the planning, conduct and dissemination of this project.Prospero registration numberCRD42020200117.

Project description:BackgroundAccess to integrated services for individuals with co-occurring substance use and mental health disorders is a long-standing public health issue. Receiving integrated treatment services are both more effective and preferred by patients and families versus parallel or fragmented care. National policy statements and expert consensus guidelines underscore the benefits of integrated treatment. Despite decades of awareness, adequate treatment for individuals with co-occurring substance use and mental health disorders occurs infrequently. The underlying disease burden associated with alcohol, illicit and prescription drug problems, as well as mental health disorders, such as depression, posttraumatic stress disorder and schizophrenia, is substantial.MethodsThis cluster randomized controlled trial (RCT) is designed to determine if the multi-component Network for the Improvement of Addiction Treatment (NIATx) strategies are effective in implementing integrated services for persons with co-occurring substance use and mental health disorders. In this study, 50 behavioral health programs in Washington State will be recruited and then randomized into one of two intervention arms: 1) NIATx implementation strategies, including coaching and learning sessions over a 12-month intervention period to implement changes targeting integrated treatment services; or 2) wait-list control. Primary outcome measures include: 1) fidelity - a standardized organizational assessment of integrated services (Dual Diagnosis in Addiction Treatment [DDCAT] Index); and 2) penetration - proportion of patients screened and diagnosed with co-occurring disorders, proportion of eligible patients receiving substance use and mental health services, and psychotropic or substance use disorder medications. Barriers and facilitators, as determinants of implementation outcomes, will be assessed using the Consolidated Framework for Implementation Research (CFIR) Index. Fidelity to and participation in NIATx strategies will be assessed utilizing the NIATx Fidelity Scale and Stages of Implementation Completion (SIC).DiscussionThis study addresses an issue of substantial public health significance: the gap in access to an evidence-based practice for integrated treatment for individuals with co-occurring mental health and substance use disorders. The study utilizes rigorous and reproducible quantitative approaches to measuring implementation determinants and strategies, and may address a longstanding gap in the quality of care for persons with co-occurring disorders.Trial registrationClinicalTrials.gov NCT03007940 . Registered 02 January 2017 - Retrospectively Registered.

Project description:BackgroundThere has been a recent growth in research addressing mental health nurses' routine physical healthcare knowledge and attitudes. We aimed to systematically review the empirical evidence about i) mental health nurses' knowledge, attitudes, and experiences of physical healthcare for mental health patients, and ii) the effectiveness of any interventions to improve these aspects of their work.MethodsSystematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Multiple electronic databases were searched using comprehensive terms. Inclusion criteria: English language papers recounting empirical studies about: i) mental health nurses' routine physical healthcare-related knowledge, skills, experience, attitudes, or training needs; and ii) the effectiveness of interventions to improve any outcome related to mental health nurses' delivery of routine physical health care for mental health patients. Effect sizes from intervention studies were extracted or calculated where there was sufficient information. An integrative, narrative synthesis of study findings was conducted.ResultsFifty-one papers covering studies from 41 unique samples including 7549 mental health nurses in 14 countries met inclusion criteria. Forty-two (82.4%) papers were published since 2010. Eleven were intervention studies; 40 were cross-sectional. Observational and qualitative studies were generally of good quality and establish a baseline picture of the issue. Intervention studies were prone to bias due to lack of randomisation and control groups but produced some large effect sizes for targeted education innovations. Comparisons of international data from studies using the Physical Health Attitudes Scale for Mental Health Nursing revealed differences across the world which may have implications for different models of student nurse preparation.ConclusionsMental health nurses' ability and increasing enthusiasm for routine physical healthcare has been highlighted in recent years. Contemporary literature provides a base for future research which must now concentrate on determining the effectiveness of nurse preparation for providing physical health care for people with mental disorder, determining the appropriate content for such preparation, and evaluating the effectiveness both in terms of nurse and patient- related outcomes. At the same time, developments are needed which are congruent with the needs and wants of patients.

Dataset Information

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

Background

Methods

Discussion

Trial registration

Publications

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

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