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Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

ABSTRACT: INTRODUCTION:Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care. METHODS AND ANALYSIS:The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions. ETHICS AND DISSEMINATION:Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER AND REGISTRY NAME:ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).

SUBMITTER: Lambert M

PROVIDER: S-EPMC7223141 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

Lambert Martin M Karow Anne A Gallinat Jürgen J Lüdecke Daniel D Kraft Vivien V Rohenkohl Anja A Schröter Romy R Finter Constanze C Siem Anna-Katharina AK Tlach Lisa L Werkle Nathalie N Bargel Susann S Ohm Gunda G Hoff Martin M Peter Helmut H Scherer Martin M Mews Claudia C Pruskil Susanne S Lüke Johannes J Härter Martin M Dirmaier Jörg J Schulte-Markwort Michael M Löwe Bernd B Briken Peer P Peper Heike H Schweiger Michael M Mösko Mike M Bock Thomas T Wittzack Martin M Meyer Hans-Jochim HJ Deister Arno A Michels Rolf R Herr Stephanie S Konnopka Alexander A König Hannah H Wegscheider Karl K Daubmann Anne A Zapf Antonia A Peth Judith J König Hans-Helmut HH Schulz Holger H

BMJ open 20200504 5

<h4>Introduction</h4>Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, as ...[more]

PMID: 32371520

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Project description:IntroductionStrengths-based approaches mobilise individual and environmental resources that can facilitate the recovery of people with mental illness. Strengths model case management (SMCM), developed by Rapp and Goscha through collaborative efforts at the University of Kansas, offers a structured and innovative intervention. As evidence of the effectiveness of strengths-based interventions come from Western studies, which lacked rigorous research design or failed to assure fidelity to the model, we aim to fill these gaps and conduct a randomised controlled trial (RCT) to test the effectiveness of SMCM for individuals with mental illness in Hong Kong.Methods and analysisThis will be an RCT of SMCM. Assuming a medium intervention effect (Cohen's d=0.60) with 30% missing data (including dropouts), 210 service users aged 18 years or above will be recruited from three community mental health centres. They will be randomly assigned to SMCM groups (intervention) or SMILE groups (control) in a 1:1 ratio. The SMCM groups will receive strengths model interventions from case workers, whereas the SMILE groups will receive generic care from case workers with an attention placebo. The case workers will all be embedded in the community centres and will be required to provide a session with service users in both groups at least once every fortnight. There will be two groups of case workers for the intervention and control groups, respectively. The effectiveness of the SMCM will be compared between the two groups of service users with outcomes at baseline, 6 and 12 months after recruitment. Functional outcomes will also be reported by case workers. Data on working alliances and goal attainment will be collected from individual case workers. Qualitative evaluation will be conducted to identify the therapeutic ingredients and conditions leading to positive outcomes. Trained outcome assessors will be blind to the group allocation.Ethics and disseminationEthical approval from the Human Research Ethics Committee at the University of Hong Kong has been obtained (HRECNCF: EA1703078). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration number12617001435370; Pre-results.

Project description:INTRODUCTION:Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a 'one size fits all' approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA. METHODS AND ANALYSIS:Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient's global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ?50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ?28?kg/m2, knee pain ?40 (Visual Analogue Scale, 0-100), PASS (0-100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle. ETHICS AND DISSEMINATION:The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12615000227594.

Project description:BackgroundThe burden of common mental disorders in low and middle-income countries (LMICs) is growing with little known about how to allocate limited resources to reach the greatest number of people undergoing instances of significant psychological distress. We present a study protocol for a multicentre, parallel-group, superiority, randomised controlled trial.Methods and analysisAdults with significant psychological distress (K10 score ≥20) will be randomised to receive a stepped care programme involving a self-guided course (Doing What Matters) followed by a more intensive group programme (Problem Management Plus) or the self-guided course alone, both of which will take place in addition to enhanced treatment as usual comprising of a follow-up referral session to available services within the community. We will include 800 participants. An intent-to-treat and completer analysis will explore the impact of the stepped model of care on anxiety and depression symptoms (as measured by the Hopkins Symptom Checklist; HSCL-25) at 24 weeks from baseline. Secondary outcomes include positive psychological well-being, agency, changes in patient-identified problems, quality of life and cost-effectiveness. Linear mixed models will be used to assess the differential impact of the conditions over time. Analyses will focus on the primary outcome (HSCL-25) and secondary outcomes (agency subscale, WHO Well-Being Index, WHO Disability Assessment Schedule V.2.0, EQ-5D, Psychological Outcomes Profiles Scale) for both conditions, with the main outcome time point being the 3-month follow-up, relative to baseline.Ethics and disseminationThis will be the first randomised controlled trial to assess the benefits of a stepped model of care to addressing psychological distress in a LMIC setting. Results will provide important insights for managing limited resources to mental healthcare in these settings and will be accordingly disseminated to service providers and organisations via professional training and meetings, and via publication in relevant journals and conference presentations. We will also present these findings to the Jordanian Ministry of Health, where this institute will guide us on the most appropriate format for communication of findings, including written reports, verbal presentations and/or brochures. Ethical approval was obtained from the University of Jordan School of Nursing Research Ethics Committee (number: PF.22.10).Trial registration numberACTRN12621000189820p; Australian New Zealand Clinical Trials Registry.

Project description:BACKGROUND:It is widely acknowledged that health policy and practice do not always reflect current research evidence. Whether knowledge transfer from research to practice is more successful when specific implementation approaches are used remains unclear. A model to assist engagement of allied health managers and clinicians with research implementation could involve disseminating evidence-based policy recommendations, along with the use of knowledge brokers. We developed such a model to aid decision-making for the provision of weekend allied health services. This protocol outlines the design and methods for a multi-centre cluster randomised controlled trial to evaluate the success of research implementation strategies to promote evidence-informed weekend allied health resource allocation decisions, especially in hospital managers. METHODS:This multi-centre study will be a three-group parallel cluster randomised controlled trial. Allied health managers from Australian and New Zealand hospitals will be randomised to receive either (1) an evidence-based policy recommendation document to guide weekend allied health resource allocation decisions, (2) the same policy recommendation document with support from a knowledge broker to help implement weekend allied health policy recommendations, or (3) a usual practice control group. The primary outcome will be alignment of weekend allied health service provision with policy recommendations. This will be measured by the number of allied health service events (occasions of service) occurring on weekends as a proportion of total allied health service events for the relevant hospital wards at baseline and 12-month follow-up. DISCUSSION:Evidence-based policy recommendation documents communicate key research findings in an accessible format. This comparatively low-cost research implementation strategy could be combined with using a knowledge broker to work collaboratively with decision-makers to promote knowledge transfer. The results will assist managers to make decisions on resource allocation, based on evidence. More generally, the findings will inform the development of an allied health model for translating research into practice. TRIAL REGISTRATION:This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) ( ACTRN12618000029291 ). Universal Trial Number (UTN): U1111-1205-2621.

Project description:BackgroundMental health problems are prevalent among Australian secondary school youth; however, help-seeking is low. Schools offer an ideal setting to address these concerns. The Black Dog Institute has developed a Web-based mental health service for secondary schools that is modeled on the principles of stepped care. The Smooth Sailing service aims to improve help-seeking and reduce anxiety and depressive symptoms in secondary school students. The acceptability of this service has been demonstrated in a pilot study. A full trial is now warranted.ObjectiveThis study protocol for a cluster randomized controlled trial (RCT) aims to evaluate the effectiveness of the Smooth Sailing Web-based service for improving help-seeking intentions and behavior, and reducing depressive and anxiety symptoms, alongside other mental health outcomes, when compared with a school-as-usual control condition in secondary school youth.MethodsThis RCT aims to recruit 1600 students from 16 secondary schools in regional and urban locations throughout New South Wales, Australia. Schools are randomly assigned to the intervention or school-as-usual control condition at the school level. Approximately 100 students from 1 or multiple grades are recruited from each participating school. Participants complete measures at 3 timepoints: baseline, 6 weeks post, and 12 weeks post, with the primary outcome assessed at 12 weeks posttest. Participants assigned to the intervention condition register to the Web-based service at baseline and receive care in accordance with the service model. Participants in the control condition receive school-as-usual.ResultsThe first baseline assessment occurred on February 22, 2018, with the 12-week endpoint assessments completed on Friday, June 29, 2018. Control schools are currently receiving the service, due for completion by June 30, 2019. The trial results are expected to demonstrate improved help-seeking intentions and behavior among students assigned to the intervention condition, alongside improvements in symptoms of depression, anxiety, distress, and other mental health outcomes when compared with students assigned to the control condition.ConclusionsTo our knowledge, this is the first time that a Web-based mental health service based on the principles of stepped care will have been integrated into, and evaluated in, the Australian school context. The findings of this trial will have implications for the suitability of this type of service model in Australian schools and for the delivery of school-based mental health services more broadly.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001539224 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821&isReview=true (Archived by WebCite at http://www.webcitation.org/77N3MDGS6).International registered report identifier (irrid)DERR1-10.2196/12892.

Project description:Health-system policy makers need timely access to synthesised research evidence to inform the policy-making process. No efforts to address this need have been evaluated using an experimental quantitative design. We developed an evidence service that draws inputs from Health Systems Evidence, which is a database of policy-relevant systematic reviews. The reviews have been (a) categorised by topic and type of review; (b) coded by the last year searches for studies were conducted and by the countries in which included studies were conducted; (c) rated for quality; and (d) linked to available user-friendly summaries, scientific abstracts, and full-text reports. Our goal is to evaluate whether a "full-serve" evidence service increases the use of synthesized research evidence by policy analysts and advisors in the Ontario Ministry of Health and Long-Term Care (MOHLTC) as compared to a "self-serve" evidence service.We will conduct a two-arm randomized controlled trial (RCT), along with a follow-up qualitative process study in order to explore the findings in greater depth. For the RCT, all policy analysts and policy advisors (n = 168) in a single division of the MOHLTC will be invited to participate. Using a stratified randomized design, participants will be randomized to receive either the "full-serve" evidence service (database access, monthly e-mail alerts, and full-text article availability) or the "self-serve" evidence service (database access only). The trial duration will be ten months (two-month baseline period, six-month intervention period, and two month cross-over period). The primary outcome will be the mean number of site visits/month/user between baseline and the end of the intervention period. The secondary outcome will be participants' intention to use research evidence. For the qualitative study, 15 participants from each trial arm (n = 30) will be purposively sampled. One-on-one semi-structured interviews will be conducted by telephone on their views about and their experiences with the evidence service they received, how helpful it was in their work, why it was helpful (or not helpful), what aspects were most and least helpful and why, and recommendations for next steps.To our knowledge, this will be the first RCT to evaluate the effects of an evidence service specifically designed to support health-system policy makers in finding and using research evidence.ClinicalTrials.gov: NCT01307228.

Project description:BackgroundMany people with eating disorders (EDs) either do not access treatment, access it well after symptoms first start, or drop out of treatment. This study evaluated ways to improve early access to evidence-based interventions for those with EDs in a non-specialist community setting.MethodsIn an Australian regional community, links were formed between general medical practitioners and treatment providers (psychologists, mental health social workers and dietitians), who received ongoing training, feedback and support. Service users had access to 20-40 subsidised treatment sessions. Data were collected from 143 patients over 18 months. Our outcomes are reported according to the RE-AIM implementation framework: Reach (we measured uptake and treatment completion); Effectiveness (impact on disordered eating cognitions, body mass index, remission, and moderators of effectiveness including illness duration, previous treatment, presence of comorbidities, presence of a normative level of disordered eating, presence of any ED behaviours, weighing in treatment, multidisciplinary case conferencing, number of dietetic sessions); Adoption (drop-out and predictors); Implementation (barriers encountered); Maintenance (subsequent activity designed to embed new practices).ResultsTreatment was completed by 71%; significant large decreases in eating disorder cognitions were achieved; remission was obtained by 37% (intent-to-treat). Treatment completion was predicted by lower baseline levels of disordered eating, uptake of ≥ 3 dietetic sessions, and ≥ 2 team case conferences. Greater improvement over time was predicted by regular case conferencing and in-session weighing.ConclusionsImplementation of this model in a regional community setting produced completion rates and outcomes comparable to those found in specialist clinical trials of ED treatments. Service providers identified care coordination as the most important factor to connect users to services and help navigate barriers to ongoing treatment.Trial registrationThis research was an invited evaluation of a project implemented by the Australian Department of Health. The project did not introduce any new clinical practice but sought to improve access to evidence-based multidisciplinary treatment for people with EDs by removing four known systemic barriers: securing an accurate diagnosis, availability of multidisciplinary treatment, cost of treatment, and intensity of treatment. As such, the project did not require trial registration. Notwithstanding, this evaluation obtained ethics approval (Bellberry Human Research Ethics Committee, Application No: 2018-09-728-FR-1).

Project description:ObjectiveTo evaluate the impact of Teach-Back on communication quality in a national telephone-based telehealth service, for callers varying in health literacy.DesignCross-sectional stepped wedge cluster randomised trial with continuous recruitment, short (fixed) exposure and blinded outcome assessors. Nurses were stratified by hours worked and randomised into training groups using a computer generated sequence.SettingAn Australian national pregnancy and parenting telephone helpline.InterventionComplex intervention involving a single 2-hour group Teach-Back training session, combined with ongoing nurse self-reflection on their communication following each call and each shift.ParticipantsParticipants were 637 callers to the telephone helpline aged 18-75 (87% female), of whom 127 (13%) had inadequate health literacy (measured with the Single Item Literacy Screener); and 15 maternal and child health nurses with 15 years' experience on average.MeasuresPrimary outcome was a modified subscale of the Health Literacy Questionnaire, 'having sufficient information to manage health'. Secondary caller outcomes included caller confidence, perceived actionability of information and nurse effort to listen and understand. Nurse outcomes were perceptions of their communication effectiveness.ResultsOver a 7 week period, 376 surveyed callers received usual care and 261 Teach-Back. Ratings on the primary outcome increased over time (OR 1.17, CI 1.01 to 1.32, p = 0.03) but no independent Teach-Back effect was observed. A consistent pattern suggests that, compared with usual care, Teach-Back helps callers with inadequate health literacy feel listened to (OR 2.3, CI 0.98 to 5.42, p = 0.06), confident to act (OR 2.44, CI 1.00 to 5.98, p = 0.06), and know what steps to take (OR 2.68, CI 1.00 to 7.17, p = 0.06). Nurse perceptions of both their own communication effectiveness (OR = 2.31; CI 1.38 to 3.86, p<0.0001), and caller understanding (OR = 2.56; CI 1.52 to 4.30, p<0.001) both increased with Teach-Back. No harms were reported.ConclusionsTeach-Back appears to benefit telephone health service users with inadequate health literacy, but the extent of this is unclear due to smaller numbers of lower literacy participants. Improving caller ratings over time are likely due to increasing nurse communication competence.

Project description:IntroductionAdolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care.Methods and analysisThis hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10-24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant.Ethics and disseminationThis study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences.Trial registration numberNCT05007717.

Dataset Information

Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

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Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

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