Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial
AbstractObjective: 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.
Bellg, A. J., Borrelli, B., Resnick, B., Hecht, J., Sharp Minicucci, D., Ory, M., Ogedegbe, G., Orwig, D., Ernst, D., Czajkowski, S., (2004) Enhancing Treatment Fidelity in Health Behavior Change Studies: Best Practices and Recommendations From the NIH Behavior Change Consortium. Health Psychology, 23(5), 443-451. Available from: doi: 10.1037/0278-622.214.171.1243
Borrelli, B., Sepinwall, D., Ernst, D., Bellg, A.J., Czajkowski, S., Breger, R., DeFrancesco, C., Levesque, C., Sharp, D. L. & Ogedegbe, G. (2005) A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behaviour research. J Consult Clin Psychol, 73(5), 852-60. Available from: doi:10.1037/0022-006X.73.5.852
Carroll, C., Patterson. M., Wood. S., Booth. A., Rick. J. & Balain. S. (2007) A conceptual framework for implementation fidelity. Implement Science, 2(40), 1-9. Available from: doi: https://doi. org/10.1186/1748-5908-2-40
Chong, H. Y., Teoh, S. L., Wu, D. B., Kotirum, S., Chiou, C. F. & Chaiyakunapruk, N. (2016) Global economic burden of schizophrenia: a systematic review. Neuropsychiatr Dis Treat, 16(12), 357-73. Available from: doi https://doi.org/10.2147/NDT.S96649
Diepeveen, S., Ling, T., Suhrcke, M., Roland, M. & Marteau, T. M. (2013) Public acceptability of government intervention to change health-related behaviours: a systematic review and narrative synthesis. BMC Public Health, 13(756), 1-11. Available from: doi: https://doi.org/10.1186/1471-2458-13-756
Farmer, T., Robinson, K., Elliott, S. J. & Eyles, J. (2006) Developing and implementing a triangulation protocol for qualitative health research. Qual Health Res, 16(3), 377-94. Available from: doi: 10.1177/1049732305285708.
Fichtenbauer, I., Priebe, S. & Schrank, B. (2019) The German Version of DIALOG+ for Patients with Psychosis-A Pilot Study. Psychiatr Prax, 46(7), 376–80. Available from: doi: 10.1055/a-0961- 3328
Hsieh, H.F. and Shannon, S.E. (2005) Three approaches to qualitative content analysis. Qualitative health research, 15(9), 1277-1288. Available from: doi: 10.1177/1049732305276687.
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D. G., Barbour, V., Macdonald, H., Johnston, M. & Lamb, S. E. (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 348, g1687. Available from: doi: 10.1136/bmj.g1687
Huang, R. (2016). RQDA: R-based Qualitative Data Analysis. R package version 0.2-8. http://rqda.r-forge.r-project.org/
Jovanović, N., Francis, J., Marić, N., Arënliu, A., Barjaktarov, S., Džubur Kulenović, A., Injac, L., Feng, Y. & Novotni, A. (2019) 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). Global Psychiatry, 2(2), 1-14. Available from: doi: https://doi. org/10.2478/gp-2019-0020
Sadock, B. J. & Sadock, V. (2014) Kaplan and Sadock’s Synopsis of Psychiatry: Behavioral Science/Clinical Psychiatry. 11th edition, Wolters Kluwer.
Kellogg Foundation, W. K. (2004) Using Logic Models to Bring Together Planning, Evaluation, and Action: Logic Model Development Guide. Battle Creek, MI: W. K. Kellogg Foundation.
Krueger, R. A. & Casey, M. A. (2000) Focus groups: A practical guide for applied research, 4th Edition. Thousand Oaks: Sage publications.
Moore, G. F., Audrey, S., Barker, M., Bond, L., Bonell, C., Hardeman, W., Moore, L., O’Cathain, A., Tinati, T., Wight, D. & Baird, J. (2015) Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 350, h1258. Available from: doi: https:// doi.org/10.1136/bmj.h125811
NICE guidelines: Psychosis and Schizophrenia in adults (2014) Available from: https://www.nice.org.uk/guidance/cg178/ evidence/full-guideline-490503565 [Accessed on 26 March 2020]
Oakley, A., Strange, V., Bonell, C., Allen, E., & Stephenson, J. (2006) Process evaluation in randomised controlled trials of complex interventions. BMJ, 332(7538), 413–16. Available from: doi: 10.1136/bmj.332.7538.413
Omer, S., Golden, E. & Priebe, S. (2016) Exploring the Mechanisms of a Patient-Centred Assessment with a Solution Focused Approach (DIALOG+) in the Community Treatment of Patients with Psychosis: A Process Evaluation within a Cluster-Randomised Controlled Trial. PLoS One, 11(2), e0148415. Available from: doi: 10.1371/journal.pone.0148415.
O’Cathain, A., Murphy, E. & Nicholl, J. (2010) Three techniques for integrating data in mixed methods studies. BMJ, 341, c4587. Available from: doi: https://doi.org/10.1136/bmj.c4587
Parkinson, S., Eatough, V., Holmes, J., Stapley, E. & Midgley, N. (2015) Framework analysis: a worked example of a study exploring young people’s experiences of depression. Qualitative Research in Psychology, 13(2), 109-129. Availabe from: https://doi.org/10.1080 /14780887.2015.1119228
Pinto, R. Z., Ferreira, M. L., Oliveira, V. C., Franco, M. R., Adams, R., Maher, C. G., & Ferreira, P. H. (2012). Patient-centred communication is associated with positive therapeutic alliance: a systematic review. Journal of physiotherapy, 58(2), 77-87. Available from: https://doi.org/10.1016/S1836-9553(12)70087-5
Priebe, S., Golden, E., Kingdon, D., Omer, S., Walsh, S., Katevas, K., McCrone, P., Eldridge, S. and McCabe, R. (2017) Effective patient– clinician interaction to improve treatment outcomes for patients with psychosis: a mixed-methods design. Programme Grants for Applied Research, 5(6).
Priebe, S., Kelley, L., Omer, S., Golden, E., Walsh, S., Khanom, H., Kingdon, D., Rutterford, C., McCrone, P. & McCabe, R. (2015) The Effectiveness of a Patient-Centred Assessment with a Solution- Focused Approach (DIALOG+) for Patients with Psychosis: A Pragmatic Cluster-Randomised Controlled Trial in Community Care. Psychother Psychosom, 84(5), 304-13. Available from: doi: 10.1159/000430991.
Priebe, S., Omer, S., Giacco, D. and Slade, M. (2014) Resource-oriented therapeutic models in psychiatry: conceptual review. The British Journal of Psychiatry, 204(4), 256-261. Available from: doi:10.1192/bjp.bp.113.135038.
Proctor, E. K., Landsverk, J., Aarons, G., Chambers, D., Glisson, C. & Mittman, B. (2009) Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health Ment Health Serv Res, 36(1), 24–34. Available from: doi: 10.1007/s10488-008-0197-4
Rabiee, F. (2004) Focus-group interview and data analysis. Proceedings of the Nutrition Society, 63(4), 655-660. Available from: doi: 10.1079/PNS2004399
Ritchie, J. & Spencer, L. (1994) Qualitative data analysis for applied policy research. In A. Bryman & R.G. Burgess (Eds.), Analysing Qualitative Data. London: Routledge pp.173-194.
Sekhon, M., Cartwright, M. & Francis, J. J. (2017) Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC health services research, 17(88), 1-13. Available from: doi: https://doi.org/10.1186/s12913-017- 2031-8
Squires, J. E., Aloisio, L. D., Grimshaw, J. M., Bashir, K., Dorrance, K., Coughlin, M., Hutchinson, A. M., Francis, J., Michie, S., Sales, A., Brehaut, J., Curran, J., Ivers, N., Lavis, J., Noseworthy, T., Vine, J., Hillmer, M. & Graham, I. D. (2019) Attributes of context relevant to healthcare professionals’ use of research evidence in clinical practice: a multi-study analysis. Implementation Science, 14(1), 52. Available from: https://doi.org/10.1186/s13012-019-0900-8
Stok, F. M., De Ridder, D. T., De Vet, E., Nureeva, L., Luszczynska, A., Wardle, J., Gaspar, T. & De Wit, J. B. (2016) Hungry for an intervention? Adolescents’ ratings of acceptability of eating-related intervention strategies. BMC Public Health, 16(5). Available from: doi: 10.1186/s12889-015-2665-6
Irazola, V. (2019) Study questions, study designs and types of evidence for implementation science, 11th Global Alliance for Chronic Diseases Implementation Science Workshop – GACD ISW, Available from: https://www.gacd.org/perch/ resources/2019iswday1.pdf
WHO 2014, Mental Health Atlas, Available at: http://www.who. int/mental_health/evidence/atlas/mental_health_atlas_2014/en/ [Accessed on 19 June 2020].
WHO 2014, Regional Office for Europe. Available from: http:// www.euro.who.int/en/health-topics/noncommunicable-diseases/ mental-health [Accessed on 26 March 2020]
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