ED to EPI: protocol for a pragmatic randomised controlled trial of an SMS (text) messaging intervention to improve the transition from the emergency department to early psychosis intervention for young people with psychosis

Alexia Polillo, George Foussias, Albert H C Wong, Augustina Ampofo, Vicky Stergiopoulos, Kelly K Anderson, Sarah Bromley, Jessica D'Arcey, Claire de Oliveira, Lillian Duda, Joanna Henderson, Sean Kidd, Paul Kurdyak, Wei Wang, Juveria Zaheer, Aristotle N Voineskos, Nicole Kozloff, Alexia Polillo, George Foussias, Albert H C Wong, Augustina Ampofo, Vicky Stergiopoulos, Kelly K Anderson, Sarah Bromley, Jessica D'Arcey, Claire de Oliveira, Lillian Duda, Joanna Henderson, Sean Kidd, Paul Kurdyak, Wei Wang, Juveria Zaheer, Aristotle N Voineskos, Nicole Kozloff

Abstract

Introduction: While nearly half of all new psychotic disorders are diagnosed in the emergency department (ED), most young people who present to the ED with psychosis do not receive timely follow-up with a psychiatrist, and even fewer with evidence-based early psychosis intervention (EPI) services. We aim to test an intervention delivered using short message service (SMS), a low-cost, low-complexity, youth-friendly approach, to improve transitions from the ED to EPI services.

Methods and analysis: This is a protocol for a pragmatic randomised, single blind, controlled trial with accompanying economic and qualitative evaluations conducted at the Centre for Addiction and Mental Health (CAMH) in Toronto, Canada. A consecutive series of 186 participants aged 16-29 referred by the ED to CAMH's EPI programme will be recruited for a trial of a two-way intervention involving reminders, psychoeducation and check-ins delivered via SMS. The primary outcome will be attendance at the first consultation appointment within 30 days of study enrolment assessed through chart reviews in the electronic health record. We will also extract routine clinical measures, including the Brief Psychiatric Rating Scale, Clinical Global Impression and Service Engagement Scale, and link with provincial health administrative data to examine system-level outcomes, including ED visits and psychiatric hospitalisations, 6 months and up to 2 years after baseline. We will perform a cost-effectiveness analysis of the primary study outcome and costs incurred, calculating an incremental cost effectiveness ratio. Web-based surveys and qualitative interviews will explore intervention user experience. Patients and families with lived experience will be engaged in all aspects of the project.

Ethics and dissemination: Research Ethics Board approval has been obtained. Findings will be reported in scientific journal articles and shared with key stakeholders including youth, family members, knowledge users and decision makers.

Trial registration number: NCT04298450.

Keywords: child & adolescent psychiatry; clinical trials; information technology; schizophrenia & psychotic disorders.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study intervention schedule. This figure represents a summary of the intervention schedule and is not exhaustive of text message content. Left arrow, outgoing text messages sent by participants; right arrow, incoming text messages received by participants; SMS, short message service.

References

    1. American Psychiatric Association Diagnostic and statistical manual of mental disorders: DSM-5. 5th edn Arlington, VA: American Psychiatric Publishing, 2013.
    1. Whiteford HA, Degenhardt L, Rehm J, et al. . Global burden of disease attributable to mental and substance use disorders: findings from the global burden of disease study 2010. Lancet 2013;382:1575–86. 10.1016/S0140-6736(13)61611-6
    1. Schoenbaum M, Sutherland JM, Chappel A, et al. . Twelve-month health care use and mortality in commercially insured young people with incident psychosis in the United States. Schizophr Bull 2017;43:1262–72. 10.1093/schbul/sbx009
    1. Zaheer J, Olfson M, Mallia E, et al. . Predictors of suicide at time of diagnosis in schizophrenia spectrum disorder: a 20-year total population study in Ontario, Canada. Schizophr Res 2020;222:382–8. 10.1016/j.schres.2020.04.025
    1. Lieberman JA, First MB. Psychotic disorders. N Engl J Med 2018;379:270–80. 10.1056/NEJMra1801490
    1. de Oliveira C, Cheng J, Rehm J, et al. . The economic burden of chronic psychotic disorders in Ontario. J Ment Health Policy Econ 2016;19:181–92.
    1. Goeree R, Farahati F, Burke N, et al. . The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin 2005;21:2017–28. 10.1185/030079905X75087
    1. Penttilä M, Jääskeläinen E, Hirvonen N, et al. . Duration of untreated psychosis as predictor of long-term outcome in schizophrenia: systematic review and meta-analysis. Br J Psychiatry 2014;205:88–94. 10.1192/bjp.bp.113.127753
    1. Anderson KK, Norman R, MacDougall A, et al. . Effectiveness of early psychosis intervention: comparison of service users and nonusers in population-based health administrative data. Am J Psychiatry 2018;175:443–52. 10.1176/appi.ajp.2017.17050480
    1. Craig TKJ, Garety P, Power P, et al. . The Lambeth early onset (LEO) team: randomised controlled trial of the effectiveness of specialised care for early psychosis. BMJ 2004;329:1067. 10.1136/bmj.38246.594873.7C
    1. Petersen L, Jeppesen P, Thorup A, et al. . A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ 2005;331:602. 10.1136/bmj.38565.415000.E01
    1. Malla A, Schmitz N, Norman R, et al. . A multisite Canadian study of outcome of first-episode psychosis treated in publicly funded early intervention services. Can J Psychiatry 2007;52:563–71. 10.1177/070674370705200904
    1. Bond GR, Drake RE, Luciano A. Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review. Epidemiol Psychiatr Sci 2015;24:446–57. 10.1017/S2045796014000419
    1. Ontario Ministry of Health and Long-Term Care Early psychosis intervention program standards. Toronto, ON; 2011.
    1. Anderson KK, Norman R, MacDougall AG, et al. . Estimating the incidence of first-episode psychosis using population-based health administrative data to inform early psychosis intervention services. Psychol Med 2019;49:1–9. 10.1017/S0033291718002933
    1. Anderson KK, Fuhrer R, Wynant W, et al. . Patterns of health services use prior to a first diagnosis of psychosis: the importance of primary care. Soc Psychiatry Psychiatr Epidemiol 2013;48:1389–98. 10.1007/s00127-013-0665-3
    1. Kozloff N, Jacob B, Voineskos AN, et al. . Care of youth in their first emergency presentation for psychotic disorder: a population-based retrospective cohort study. J Clin Psychiatry 2018;7910.4088/JCP.17m11947
    1. Lal S, Dell'Elce J, Tucci N, et al. . Preferences of young adults with first-episode psychosis for receiving specialized mental health services using technology: a survey study. JMIR Ment Health 2015;2:e18. 10.2196/mental.4400
    1. Voineskos AN, Foussias G, et al. , Kozloff N . Patient and family perspectives on improving engagement in early psychosis intervention. Congress of the Schizophrenia International Research Society; April 10-14, 2019, Orlando, FL, 2019.
    1. Polillo A, Voineskos A, et al. , Sav A . Using REDCap to evaluate youth and family perspectives on engagement in early psychosis intervention. REDCap Con December 2019; December 12, 2019, Toronto, ON, Canada, 2019.
    1. Firth J, Torous J. Smartphone apps for schizophrenia: a systematic review. JMIR Mhealth Uhealth 2015;3:e102. 10.2196/mhealth.4930
    1. D'Arcey J, Collaton J, Kozloff N, et al. . The use of text messaging to improve clinical engagement for individuals with psychosis: systematic review. JMIR Ment Health 2020;7:e16993. 10.2196/16993
    1. Alvarez-Jimenez M, Alcazar-Corcoles MA, González-Blanch C, et al. . Online, social media and mobile technologies for psychosis treatment: a systematic review on novel user-led interventions. Schizophr Res 2014;156:96–106. 10.1016/j.schres.2014.03.021
    1. Ennis L, Rose D, Denis M, et al. . Can’t surf, won’t surf: the digital divide in mental health. J Ment Health 2012;21:395–403. 10.3109/09638237.2012.689437
    1. Kauppi K, Kannisto KA, Hätönen H, et al. . Mobile phone text message reminders: measuring preferences of people with antipsychotic medication. Schizophr Res 2015;168:514–22. 10.1016/j.schres.2015.07.044
    1. Thomas IF, Lawani AO, James BO. Effect of short message service reminders on clinic attendance among outpatients with psychosis at a psychiatric hospital in Nigeria. Psychiatr Serv 2017;68:75–80. 10.1176/appi.ps.201500514
    1. Using short message service as a means of engagement in early psychosis IEPA 11th International Conference on Early Intervention in Mental Health - ‘Prevention and Early Intervention: Broadening the Scope’; October 7-10 2018. Boston, Massachusetts, USA. Early Interv Psychiatry.
    1. Meinecke A-K, Welsing P, Kafatos G, et al. . Series: pragmatic trials and real world evidence: paper 8. data collection and management. J Clin Epidemiol 2017;91:13–22. 10.1016/j.jclinepi.2017.07.003
    1. Thorpe KE, Zwarenstein M, Oxman AD, et al. . A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464–75. 10.1016/j.jclinepi.2008.12.011
    1. Voineskos AN, Foussias G, et al. , Kozloff N . Improving youth engagement in early psychosis intervention programs: preliminary results from a youth survey. 66th Annual Meeting of the American Academy of Child and Adolescent Psychiatry; October 14-19, 2019, Chicago, IL, USA, 2019:S334–5. 10.1016/j.jaac.2019.07.791
    1. Lecomte T, Abidi S, Garcia-Ortega I, et al. . Canadian treatment guidelines on psychosocial treatment of schizophrenia in children and youth. Can J Psychiatry 2017;62:648–55. 10.1177/0706743717720195
    1. Keepers GA, Fochtmann LJ, Anzia JM, et al. . The American psychiatric association practice guideline for the treatment of patients with schizophrenia. Am J Psychiatry 2020;177:868–72. 10.1176/appi.ajp.2020.177901
    1. Vanderbilt University REDCap (research electronic data capture), 2018. Available: [Accessed 2 Apr 2020].
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Harris PA, Taylor R, Minor BL, et al. . The REDCap Consortium: building an international community of software platform partners. J Biomed Inform 2019;95:103208. 10.1016/j.jbi.2019.103208
    1. Tait L, Birchwood M, Trower P. A new scale (SES) to measure engagement with community mental health services. J Ment Health 2002;11:191–8. 10.1080/09638230020023570-2
    1. Flemenbaum A, Zimmermann RL. Inter- and intra-rater reliability of the brief psychiatric rating scale. Psychol Rep 1973;32:783–92. 10.2466/pr0.1973.33.3.783
    1. Guy W. Clinical global impressions. ECDEU assessment manual for psychopharmacology. Rockville, Maryland: National Institute for Mental Health, 1976: 218–22.
    1. Canadian Institute for Health Information Ontario mental health reporting system, data quality documentation, 2015–2016. Ottawa, ON, Canada: CIHI; 2017.
    1. Williams JI, Young W. A summary of studies on the quality of health care administrative databases in Canada : Goel V, Williams JI, Anderson GM, et al., Patterns of health care in Ontario the ICES practice atlas. 2nd edn Ottawa, ON: Canadian Medical Association, 1996.
    1. Juurlink DN, Preyra C, Croxford R. Canadian Institute for Health Information Discharge Abstract Database:A Validation Study. Toronto, ON, Canada: Institute for Clinical Evaluative Sciences; 2006.
    1. Canadian Institute for Health Information CIHI data quality study of Ontario emergency department visits for 2004–2005. Ottawa, ON, Canada: CIHI; 2008.
    1. McCullagh P, Nelder JA. Generalized linear models. Second Edition London, UK: Chapman and Hall, 1989.
    1. McNutt L-A, Wu C, Xue X, et al. . Estimating the relative risk in cohort studies and clinical trials of common outcomes. Am J Epidemiol 2003;157:940–3. 10.1093/aje/kwg074
    1. Doyle R, Turner N, Fanning F, et al. . First-episode psychosis and disengagement from treatment: a systematic review. Psychiatr Serv 2014;65:603–11. 10.1176/appi.ps.201200570
    1. Wang W, Ma Y, Huang Y, et al. . Generalizability analysis for clinical trials: a simulation study. Stat Med 2017;36:1523–31. 10.1002/sim.7238
    1. Schafer JL. Analysis of incomplete multivariate data. London, UK: Chapman & Hall, 1997.
    1. Wodchis WP, Austin PC, Henry DA. A 3-year study of high-cost users of health care. CMAJ 2016;188:182–8. 10.1503/cmaj.150064
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Damschroder LJ, Aron DC, Keith RE, et al. . Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009;4:50. 10.1186/1748-5908-4-50

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