Keywords : Trial
Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial
2021, Volume 4, Issue 1, Pages 20-30
Objective: This paper describes the protocol of a process evaluation of a cluster randomised controlled trial designed to evaluate the effectiveness, cost-effectiveness and implementation of a digital mental health intervention, called DIALOG+, in five low- and middle-income countries in Southeast Europe (Bosnia and Herzegovina, Kosovo1, Montenegro, North Macedonia and Serbia). The objectives of the process evaluation are: a) to explore attributes of context that might impact on the implementation of the DIALOG+ intervention; b) to assess intervention fidelity and c) to explore patients’ and clinicians’ retrospective (i.e. experienced) acceptability of the intervention.
Materials and methods: This is a mixed-method process evaluation nested within the cluster randomised controlled trial. We adopted the guidance on process evaluations of complex interventions published by the United Kingdom Medical Research Council. Data collected during and after the trial, but prior to awareness of trial outcomes, include transcripts, questionnaire responses, routinely collected monitoring data and audio-recordings of intervention and control sessions. Data analysis is descriptive and involves triangulation methods to compare findings across countries, stakeholder groups (healthcare provider, patient) and data type (qualitative, quantitative).
Results: This work is part of a larger study entitled ‘Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle-income countries in Southeast Europe’ (IMPULSE). The study is funded by the European Union’s Horizon 2020 research and innovation programme. The IMPULSE trial recruited 81 clinicians and 458 patients. The clinician clusters were randomised to the intervention (six sessions of DIALOG+ over 12 months) or treatment-as-usual arm. Process data collection began in parallel with the trial, starting in April 2019. Data collection and analysis will be completed before the main trial findings are known. Process evaluation findings will be used to interpret the trial results including assessing the effect of context on outcomes.
Conclusion: This process evaluation will explore the context, intervention fidelity and acceptability to contextualise the trial results, help in optimising sustainability of the intervention and inform its future dissemination. The methods described here may also inform the development and implementation of other complex psychosocial interventions in low-resource settings.
Implementing a psychosocial intervention DIALOG+ for patients with psychotic disorders in low and middle income countries in South Eastern Europe: protocol for a hybrid effectiveness-implementation cluster randomized clinical trial (IMPULSE)
2020, Volume 3, Issue 1, Pages 83-96
Psychotic disorders have large treatment gap in low- and middle-income countries (LMICs) in South-Eastern Europe, where up to 45% of affected people do not receive care for their condition. This study will assess the implementation of a generic psychosocial intervention called DIALOG+ in mental health care services and its effectiveness at improving patients’ clinical and social outcomes.
This is a protocol for a multi-country, pragmatic, hybrid effectiveness–implementation, cluster-randomised, clinical trial. The trial aims to recruit 80 clinicians and 400 patients across 5 South-Eastern European LMICs: Bosnia and Herzegovina, Kosovo*, Montenegro, Republic of North Macedonia and Serbia. Clusters are clinicians working with patients with psychosis, and each clinician will deliver the intervention to five patients. After patient baseline assessments, clinicians will be randomly assigned to either the DIALOG+ intervention or treatment as usual, with an allocation ratio of 1:1. The intervention will be delivered six times over 12 months during routine clinical meetings. TThe primary outcome measure is the quality of life at 12 months [Manchester Short Assessment of Quality of Life (MANSA)]; the secondary outcomes include mental health symptoms [Brief Psychiatric Rating Scale (BPRS), Clinical Assessment Interview for Negative Symptoms (CAINS), Brief Symptom Inventory (BSI)], satisfaction with services [Client Satisfaction Questionnaire (CSQ-8)] and economic costs at 12 months [based on Client Service Receipt Inventory (CSRI), EQ-5D-5L and Recovering Quality of Life (ReQOL-10)]. The study will assess the intervention fidelity and the experience of clinicians and patients’ about implementing DIALOG+ in real-life mental health care settings. In the health economic assessment, the incremental cost-effectiveness ratio is calculated with effectiveness measured by quality-adjusted life year. Data will also be collected on sustainability and reach to inform guidelines for potentially scaling up and implementing the intervention widely. Conclusion: The study is expected to generate new scientific knowledge on the treatment of people with psychosis in health care systems with limited resources. The learning from LMICs could potentially help other countries to expand the access to care and alleviate the suffering of patients with psychosis and their families.
Trial registration: ISRCTN 11913964