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Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

ABSTRACT: INTRODUCTION:Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual. METHODS AND ANALYSIS:In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion. ETHICS AND DISSEMINATION:The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare. TRIAL REGISTRATION NUMBER:NCT03226743.

SUBMITTER: Heddaeus D

PROVIDER: S-EPMC6887029 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Project description:IntroductionGiven that polypharmacy and potentially inappropriate prescribing are common in elderly orthopaedic patients, pharmacist interventions to improve medication practices among this population are important. However, past studies have reported mixed results regarding the effectiveness of pharmacist-led interventions in inpatient elderly care. Furthermore, few randomised controlled trials have evaluated patient-relevant outcomes as a primary endpoint. Therefore, we will evaluate whether a pharmacist-led intervention could reduce readmission of hospitalised elderly orthopaedic patients with polypharmacy or potentially inappropriate prescribing.Methods and analysisThis is an ongoing single-centre, prospective, non-blinded, randomised controlled trial designed to evaluate the superiority of a pharmacist-led intervention for hospitalised elderly patients compared with usual care. The trial will include newly admitted orthopaedic patients 70 years of age and older with polypharmacy or at least one potentially inappropriate prescription, as identified by the screening tool of older people's prescriptions (STOPP) criteria. Usual care includes medication reconciliation, patient education and monitoring, as well as providing information about discharge medications. Pharmacist interventions, in addition to usual care, include advising the patient's physician to stop unnecessary or inappropriate medications and start necessary medications. The primary outcome is the 1-year readmission rate. Secondary outcomes are the proportion of patients who undergo emergency department visits and the occurrences of all-cause death, a new fracture, myocardial infarction and ischaemic stroke. The study started in November 2017, and up to approximately 220 patients will be enrolled.Ethics and disseminationThe protocol was approved by the Medical Ethics Committee of the National Hospital Organization Tochigi Medical Center (No. 29-22). The trial was registered at the University Hospital Medical Information Network (UMIN) clinical registry. The results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN000029404.

Project description:ObjectiveThis study aimed to assess the feasibility of a future trial comparing the collaborative care model with usual care for patients with musculoskeletal conditions and co-existing symptoms of anxiety and depression.DesignA single-centre, parallel-arm, one-to-one, randomised controlled trial design using a mixed-methods approach was used. semistructured interviews and focus groups were conducted post intervention with all participants and staff respectively to explore acceptability towards the model and identify recommendations for improvements.SettingAn orthopaedic rehabilitation outpatient tertiary hospital.ParticipantsAdult patients with musculoskeletal conditions and co-existing moderate or severe symptoms of anxiety and depression attending outpatient therapy appointments.InterventionThe collaborative care model consisted of a tailored management programme to facilitate the integration of care provided by physical and mental healthcare professionals. A case manager screened and coordinated targeted mental health support for participants. Participants allocated to usual care had no support from the case manager.Main outcomes measureFeasibility indicators (rates of recruitment, randomisation and retention), acceptability of clinical outcome measures, usage of additional resources and cost of intervention implementation.ResultsOf the 89 patients who provided consent to take part, 40 participants who matched the eligibility criteria were randomised to either the intervention (n=20) or usual care arm (n=20). Overall adherence to the intervention was 58.82%, while the withdrawal rate was 37.5% at 6 months. All of the 27 participants who were retained completed self-reported outcomes. Qualitative data highlighted that integrated mental health support was favourably perceived. In addition to prenegotiating protected psychology time, the need for operationalised communication between the case manager and clinicians was identified as a recommendation for a future trial.ConclusionsThe trial and intervention were acceptable to patients and healthcare professionals. While the findings demonstrate the feasibility of trial recruitment, a future trial will require optimised retention strategies to improve adherence and withdrawal rates.Trial registration numberNCT05018039.

Project description:BackgroundMore than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention "Mein Weg" (English "My Way"), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).MethodsIn a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention "Mein Weg" delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.DiscussionThe trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.Trial registrationGerman Clinical Trials Register DRKS00017453 . Registered on 11 December 2019.

Project description:BACKGROUND:German statutory health insurances are pursuing the goal of improving treatment of chronically ill people by promoting networks of health care providers and supporting treatments that reflect the current medical knowledge. The so-called PNP program is a collaborative care program developed by a German statutory health insurance, which defines specific rules on psychiatric, neurological, psychosomatic, and psychotherapeutic treatment. It aims to strengthen provision of guideline-based outpatient treatment and collaboration between different health care providers. It includes the general practitioners' program, which aims to strengthen the coordinating role of GPs. This study aims to evaluate the PNP program. METHODS:To evaluate the effectiveness of the PNP program, we will conduct a prospective non-randomized controlled trial with primary data comparing patients enrolled in the PNP program and in the general practitioner program (intervention group) to patients enrolled only in the general practitioner program and patients who receive usual care (control groups). To evaluate costs and level of detail of diagnoses in care of patients with PNP program, we will use routinely collected secondary administrative health data in a retrospective quasi-experimental design. Patients who are at least 18 years old, insured by the statutory health insurance AOK, and on sick leave due to one of the mental or neurological diagnoses (affective, anxiety, somatoform or adjustment disorders, alcohol use disorders, schizophrenia, multiple sclerosis) will be included. We will collect data at baseline and at 12-months follow-up. Health-related quality of life (primary data) and direct costs (secondary data) caused by outpatient and inpatient service utilization and medication will be the primary outcomes. We will analyze data using (generalized) linear mixed models and exploratory analyses. We will use entropy balancing to control for possible differences between the groups. We will use an exploratory sequential design including qualitative and descriptive statistical analyses to assess the structure and process quality of the PNP program among health care providers. DISCUSSION:The results will help to develop a comprehensive picture of collaborative care programs for mental and neurological health care from the perspective of patients, health care providers, and health insurance companies. TRIAL REGISTRATION:German Clinical Trial Register DRKS00013114.

Project description:BackgroundDepression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline "Unipolar Depression" has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression.MethodsThis prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12?months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by 'multiple imputation using chained equations' based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered.ResultsWe found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [-€259;€10,290) and effects (+?0.008 QALY; 95%-CI: [-?0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained).ConclusionsWe found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual.Trial registrationNCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

Project description:BackgroundCollaborative and stepped care (CSC) models are recommended for mental disorders. Their successful implementation depends on effective collaboration between involved care providers from primary and specialist care. To gain insights into the collaboration experiences of care providers in CSC against the backdrop of usual mental health care, a qualitative process evaluation was realized as part of a cluster-randomized controlled trial (COMET) of a collaborative and stepped care model in Hamburg (Germany).MethodsSemi-structured interviews were conducted with N = 24 care providers from primary and specialist care (outpatient psychotherapists and psychiatrists, inpatient/ day clinic mental health providers) within and outside of COMET at the trial's beginning and 12 months later. Interviews were analyzed applying a qualitative structuring content analysis approach, combining deductive and inductive category development.ResultsUsual mental health care was considered deficient in resources, with collaboration being scarce and mainly taking place in small informal networks. Within the COMET trial, quicker referral paths were welcomed, as were quarterly COMET network meetings which provided room for exchange and fostered mutual understanding. Yet, also in COMET, collaboration remained difficult due to communication problems, the unfavorable regional distribution of the COMET care providers and interprofessional discrepancies regarding each profession's role, competencies and mutual esteem. Ideas for improvement included more localized networks, the inclusion of further professions and the overall amelioration of mental health care regarding resources and remuneration, especially for collaborative activities.ConclusionsThe process evaluation of the COMET trial revealed the benefits of creating room for interprofessional encounter to foster collaborative care. Despite the benefits of faster patient referrals, the COMET network did not fulfill all care providers' prior expectations. A focus should be set on interprofessional competencies, mutual perception and role clarification, as these have been revealed as significant barriers to collaboration within CSC models such as COMET.Trial registrationThe COMET trial (Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers) has been registered on July 24, 2017 under the trial registration number NCT03226743 .

Project description:Background: Epilepsy is one of the most common chronic paediatric conditions. Children and young people with epilepsy are at a significantly higher risk of developing mental health problems relative to the general population, yet the majority of these problems are unrecognised and under-treated in clinical practice. Although there is little epilepsy-specific guidance as to what interventions to use, researchers suggest there is no reason why clinicians should not be using the evidence base. Given the poor prognosis of untreated mental health difficulties, this cohort study sought to identify what psychological treatment young people with epilepsy with mental health needs receive in routine practice. Methods: Participants were children and young people aged 3 to 18 attending paediatric neurology clinics. The parents of those children who met threshold for impairing symptoms on the Strengths and Difficulties questionnaire were asked to complete the Development and Well-being Assessment (DAWBA), an online clinical assessment designed to generate psychiatric diagnoses. Participants who met clinical threshold for a disorder according to the DAWBA were provided with a bespoke measure asking questions regarding their experience with treatment for mental health support. Results: 16 of the 46 parents who completed the DAWBA reported that they had experienced previous or current support for their child's mental health difficulties. The mental health support offered to families was highly variable, inadequate and often not clearly compliant with existing UK National Institute for Health and Clinical Excellence (NICE) guidelines for mental health treatment in children and young people. Conclusions: The present study demonstrates the inconsistency and inadequacy of mental health provision for children and young people with epilepsy. Future work should explore reasons for the treatments offered failing to adhere to existing guidance for mental health difficulties in children, as well as possible solutions to this.

Project description:BackgroundCollaborative care for depression is more effective in improving treatment outcomes than primary care physicians' (PCPs) usual care (UC). However, few trials of collaborative care have targeted anxiety.ObjectiveTo examine the impact and 12-month durability of a centralized, telephone-delivered, stepped collaborative care intervention (CC) for treating anxiety disorders across a network of primary care practices.DesignRandomized controlled trial with blinded outcome assessments.ParticipantsA total of 329 patients aged 18-64 referred by their PCPs in response to an electronic medical record (EMR) prompt. They include 250 highly anxious patients randomized to either CC or to UC, and 79 moderately anxious patients who were triaged to a watchful waiting (WW) cohort and later randomized if their conditions clinically deteriorated.InterventionTwelve months of telephone-delivered CC involving non-mental health professionals who provided patients with basic psycho-education, assessed preferences for guideline-based pharmacotherapy, monitored treatment responses, and informed PCPs of their patients' care preferences and progress via the EMR.Main measuresMental health-related quality of life ([HRQoL]; SF-36 MCS); secondary outcomes: anxiety (Hamilton Anxiety Rating Scale [SIGH-A], Panic Disorder Severity Scale) and mood (PHQ-9).Key resultsAt 12-month follow-up, highly anxious patients randomized to CC reported improved mental HRQoL (effect size [ES]: 0.38 [95 % CI: 0.13-0.63]; P = 0.003), anxiety (SIGH-A ES: 0.30 [0.05-0.55]; P = 0.02), and mood (ES: 0.45 [0.19-0.71] P = 0.001) versus UC. These improvements were sustained for 12 months among African-Americans (ES: 0.70-1.14) and men (ES: 0.43-0.93). Of the 79 WW patients, 29 % met severity criteria for randomization, and regardless of treatment assignment, WW patients reported fewer anxiety and mood symptoms and better mental HRQoL over the full 24-month follow-up period than highly anxious patients who were randomized at baseline.ConclusionsTelephone-delivered, centralized, stepped CC improves mental HRQoL, anxiety and mood symptoms. These improvements were durable and particularly evident among those most anxious at baseline, and among African-Americans and men.

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Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

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