Dataset Information

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

ACCESS DATA

Publications

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.

Heddaeus Daniela D Dirmaier Jörg J Brettschneider Christian C Daubmann Anne A Grochtdreis Thomas T von dem Knesebeck Olaf O König Hans-Helmut HH Löwe Bernd B Maehder Kerstin K Porzelt Sarah S Rosenkranz Moritz M Schäfer Ingo I Scherer Martin M Schulte Bernd B Wegscheider Karl K Weigel Angelika A Werner Silke S Zimmermann Thomas T Härter Martin M

BMJ open 20191124 11

<h4>Introduction</h4>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 depressi ...[more]

PMID: 31767595

Similar Datasets

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: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:BACKGROUND:Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. METHODS:This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team's satisfaction. DISCUSSION:This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02598115 . Registered on 4 November 2015.

Project description:BackgroundPeople with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders.MethodsThree cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months.DiscussionResults will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders.Trial registrationClinicalTrials.gov, ID: NCT02678624 . Retrospectively registered 7 February 2016; last updated 15 August 2016.

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:BackgroundMalawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.MethodsWe will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.DiscussionThis study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.Trial registrationClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

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: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.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets