The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting

M P Rozing, A Jønsson, R Køster-Rasmussen, T D Due, J Brodersen, K H Bissenbakker, V Siersma, S W Mercer, A D Guassora, J Kjellberg, P K Kjellberg, M H Nielsen, I Christensen, J E Bardram, F Martiny, A Møller, S Reventlow, SOFIA Study Group, M P Rozing, A Jønsson, R Køster-Rasmussen, T D Due, J Brodersen, K H Bissenbakker, V Siersma, S W Mercer, A D Guassora, J Kjellberg, P K Kjellberg, M H Nielsen, I Christensen, J E Bardram, F Martiny, A Møller, S Reventlow, SOFIA Study Group

Abstract

Background: People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility of a coordinated co-produced care program (SOFIA model, a Danish acronym for Severe Mental Illness and Physical Health in General Practice) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness.

Methods: The SOFIA pilot trial is designed as a cluster randomized controlled trial targeting general practices in two regions in Denmark. We aim to include 12 practices, each of which is instructed to recruit up to 15 community-dwelling patients aged 18 and older with SMI. Practices will be randomized by a computer in a ratio of 2:1 to deliver a coordinated care program or usual care during a 6-month study period. A randomized algorithm is used to perform randomization. The coordinated care program includes educational training of general practitioners and their clinical staff educational training of general practitioners and their clinical staff, which covers clinical and diagnostic management and focus on patient-centered care of this patient group, after which general practitioners will provide a prolonged consultation focusing on individual needs and preferences of the patient with SMI and a follow-up plan if indicated. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Assessments of the outcome parameters will be administered at baseline, throughout, and at end of the study period.

Discussion: If necessary the intervention will be revised based on results from this study. If delivery of the intervention, either in its current form or after revision, is considered feasible, a future, definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place. Successful implementation of the intervention would imply preliminary promise for addressing health inequities in patients with SMI.

Trial registration: The trial was registered in Clinical Trials as of November 5, 2020, with registration number NCT04618250 . Protocol version: January 22, 2021; original version.

Keywords: Morbidity; Mortality; Pilot study; Primary care; Quality of life; Severe mental illness.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

References

    1. World Health Organization . Helping people with severe mental disorders live longer and healthier lives Geneva. 2017.
    1. Chang CK, Hayes RD, Perera G, Broadbent MT, Fernandes AC, Lee WE, et al. Life expectancy at birth for people with serious mental illness and other major disorders from a secondary mental health care case register in London. PLoS One. 2011;6(5):e19590. doi: 10.1371/journal.pone.0019590.
    1. Hiroeh U, Appleby L, Mortensen PB, Dunn G. Death by homicide, suicide, and other unnatural causes in people with mental illness: a population-based study. Lancet. 2001;358(9299):2110–2112. doi: 10.1016/S0140-6736(01)07216-6.
    1. Harris EC, Barraclough B. Suicide as an outcome for mental disorders. A meta-analysis. Br J Psychiatry. 1997;170(3):205–228. doi: 10.1192/bjp.170.3.205.
    1. Crump C, Winkleby MA, Sundquist K, Sundquist J. Comorbidities and mortality in persons with schizophrenia: a Swedish national cohort study. Am J Psychiatry. 2013;170(3):324–333. doi: 10.1176/appi.ajp.2012.12050599.
    1. Kugathasan P, Johansen MB, Jensen MB, Aagaard J, Nielsen RE, Jensen SE. Coronary artery calcification and mortality risk in patients with severe mental illness. Circ Cardiovasc Imaging. 2019;12(3):e008236. doi: 10.1161/CIRCIMAGING.118.008236.
    1. Laursen TM, Munk-Olsen T, Gasse C. Chronic somatic comorbidity and excess mortality due to natural causes in persons with schizophrenia or bipolar affective disorder. PLoS One. 2011;6(9):e24597. doi: 10.1371/journal.pone.0024597.
    1. Lawrence D, Hancock KJ, Kisely S. The gap in life expectancy from preventable physical illness in psychiatric patients in Western Australia: retrospective analysis of population based registers. BMJ. 2013;346:f2539. doi: 10.1136/bmj.f2539.
    1. Kugathasan P, Wu H, Gaughran F, Nielsen RE, Pritchard M, Dobson R, Stewart R, Stubbs B. Association of physical health multimorbidity with mortality in people with schizophrenia spectrum disorders: Using a novel semantic search system that captures physical diseases in electronic patient records. Schizophr Res. 2020;216:408–415. doi: 10.1016/j.schres.2019.10.061.
    1. Gardner-Sood P, Lally J, Smith S, Atakan Z, Ismail K, Greenwood KE, et al. Cardiovascular risk factors and metabolic syndrome in people with established psychotic illnesses: baseline data from the IMPaCT RCT study--Corrigendum. Psychol Med. 2015;45(12):2631. doi: 10.1017/S0033291715001154.
    1. Vancampfort D, Correll CU, Galling B, Probst M, De Hert M, Ward PB, et al. Diabetes mellitus in people with schizophrenia, bipolar disorder and major depressive disorder: a systematic review and large scale meta-analysis. World Psychiatry. 2016;15(2):166–174. doi: 10.1002/wps.20309.
    1. Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, et al. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry. 2015;14(3):339–347. doi: 10.1002/wps.20252.
    1. Correll CU, Detraux J, De Lepeleire J, De Hert M. Effects of antipsychotics, antidepressants and mood stabilizers on risk for physical diseases in people with schizophrenia, depression and bipolar disorder. World Psychiatry. 2015;14(2):119–136. doi: 10.1002/wps.20204.
    1. Penninx B, Lange SMM. Metabolic syndrome in psychiatric patients: overview, mechanisms, and implications. Dialogues Clin Neurosci. 2018;20(1):63–73. doi: 10.31887/DCNS.2018.20.1/bpenninx.
    1. Henderson DC, Vincenzi B, Andrea NV, Ulloa M, Copeland PM. Pathophysiological mechanisms of increased cardiometabolic risk in people with schizophrenia and other severe mental illnesses. Lancet Psychiatry. 2015;2(5):452–464. doi: 10.1016/S2215-0366(15)00115-7.
    1. Larsen JR, Siersma VD, Davidsen AS, Waldorff FB, Reventlow S, de Fine Olivarius N. The excess mortality of patients with diabetes and concurrent psychiatric illness is markedly reduced by structured personal diabetes care: A 19-year follow up of the randomized controlled study Diabetes Care in General Practice (DCGP) Gen Hosp Psychiatry. 2016;38:42–52. doi: 10.1016/j.genhosppsych.2015.10.001.
    1. Angermeyer MC, Matschinger H. The stigma of mental illness: effects of labelling on public attitudes towards people with mental disorder. Acta Psychiatr Scand. 2003;108(4):304–309. doi: 10.1034/j.1600-0447.2003.00150.x.
    1. Corrigan P. How stigma interferes with mental health care. Am Psychol. 2004;59(7):614–625. doi: 10.1037/0003-066X.59.7.614.
    1. Corrigan PW, Watson AC. Understanding the impact of stigma on people with mental illness. World Psychiatry. 2002;1(1):16–20.
    1. Reventlow SJA, Møller MCR, Davidsen AS, Olsen L. Co-producing healthcare interventions: transforming transdisciplinary research to develop healthcare services to meet the needs of patients with complex problems. In: Sturmberg J, editor. Embracing Complexity in Health: The Transformation of Science, Practice, and Policy. 1st ed. Cham: Springer International Publishing; 2019.
    1. Davidsen AS, Davidsen J, Jonsson ABR, Nielsen MH, Kjellberg PK, Reventlow S. Experiences of barriers to trans-sectoral treatment of patients with severe mental illness. A qualitative study. Int J Ment Heal Syst. 2020;14(1):87. doi: 10.1186/s13033-020-00419-x.
    1. Moffat K, Mercer SW. Challenges of managing people with multimorbidity in today's healthcare systems. BMC Fam Pract. 2015;16:129. doi: 10.1186/s12875-015-0344-4.
    1. Mercer SW, Fitzpatrick B, Guthrie B, Fenwick E, Grieve E, Lawson K, et al. The CARE Plus study - a whole-system intervention to improve quality of life of primary care patients with multimorbidity in areas of high socioeconomic deprivation: exploratory cluster randomised controlled trial and cost-utility analysis. BMC Med. 2016;14(1):88. doi: 10.1186/s12916-016-0634-2.
    1. Salisbury C, Man MS, Bower P, Guthrie B, Chaplin K, Gaunt DM, et al. Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach. Lancet. 2018;392(10141):41–50. doi: 10.1016/S0140-6736(18)31308-4.
    1. Smith SM, Wallace E, O'Dowd T, Fortin M. Interventions for improving outcomes in patients with multimorbidity in primary care and community settings. Cochrane Database Syst Rev. 2016;3:CD006560. doi: 10.1002/14651858.CD006560.pub3.
    1. Sugg HVR, Richards DA, Frost J. Optimising the acceptability and feasibility of novel complex interventions: an iterative, person-based approach to developing the UK Morita therapy outpatient protocol. Pilot Feasibility Stud. 2017;3:37. doi: 10.1186/s40814-017-0181-4.
    1. Larsen JH, Risor O, Putnam S. P-R-A-C-T-I-C-A-L: a step-by-step model for conducting the consultation in general practice. Fam Pract. 1997;14(4):295–301. doi: 10.1093/fampra/14.4.295.
    1. Tomaz VS, David MM. Transfer of learning as boundary crossing between cultural-historical activity systems. In: Hohensee C, Lobato J, editors. Transfer of Learning: Progressive Perspectives for Mathematics Education and Related Fields. Cham: Springer International Publishing; 2021. pp. 221–249.
    1. Brand SLQC, Pearson M, Lennox C, Owens C, Kirkpatrick T, Callaghan L, Stirzaker A, Michie S, Maguire M. Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial. Evaluation. 2019;25(2):149–170. doi: 10.1177/1356389018802134.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20(10):1727–1736. doi: 10.1007/s11136-011-9903-x.
    1. Kennedy-Martin T, Curtis S, Faries D, Robinson S, Johnston J. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials. 2015;16:495. doi: 10.1186/s13063-015-1023-4.
    1. Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med. 2009;6(5):e1000065. doi: 10.1371/journal.pmed.1000065.
    1. Rimmer A. Patients have struggled to access general practice during the pandemic, Healthwatch reports. BMJ. 2021;372:n798. doi: 10.1136/bmj.n798.
    1. Bhaskar S, Rastogi A, Menon KV, Kunheri B, Balakrishnan S, Howick J. Call for action to address equity and justice divide during COVID-19. Front Psychiatry. 2020;11:559905. doi: 10.3389/fpsyt.2020.559905.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner