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BMC Psychiatry
Published in: BMC Psychiatry 1/2017

Open Access 01-12-2017 | Study protocol

Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services

Authors: Maritta Välimäki, Min Yang, Sharon-Lise Normand, Kate R. Lorig, Minna Anttila, Tella Lantta, Virve Pekurinen, Clive E. Adams

Published in: BMC Psychiatry | Issue 1/2017

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Abstract

Background

People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the well-being of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients’ conditions, but also treatment environment and ward culture may affect patients’ behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods.

Methods

This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff).

Discussion

The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials.

Trial registration

ClinicalTrials.gov NCT02724748. Registered on 25th of April 2016.
Literature
1.
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jönsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21:655–79.CrossRefPubMed
2.
Alonso J, Angermeyer MC, Lépine JP, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. he European Study of the Epidemiology of Mental Disorders (ESEMeD) project: an epidemiological basis for informing mental health policies in Europe. Acta Psychiatr Scand. 2004;109 Suppl 420:5–7.CrossRef
3.
Bloom DE, Cafiero ET, Jan’e-Llopis E, Abrahams-Gessel S, Bloom LR, Fathima S, Feigl AB, Gaziano T, Mowafi M, Pandya A, Prettner K, Rosenberg L, Seligman B, Stein AZ, Weinstein C. The global economic burden of non-communicable diseases. A report of the World Economic Forum and the Harvard School of Public Health. Geneva: World Economic Forum; 2011.
4.
5.
6.
Elbogen EB, Johnson SC. The intricate link between violence and mental disorder: results from the National Epidemiologic Survey on alcohol and Related Conditions. Arch Gen Psychiatry. 2009;66:152–61.CrossRefPubMed
7.
Pinna F, Tusconi M, Dessi C, Pittaluga G, Fiorillo A, Carpiniello B. Violence and mental disorders. A retrospective study of people in charge of a community mental health center. Int J Law Psychiatry. 2016;47:122–8.CrossRefPubMed
8.
Miranda H, Punnett L, Gore R, Boyer J. Violence at workplace increases the risk of musculoskeletal pain among nursing home workers. Int J Occup Environ Med. 2011;68:52–7.CrossRef
9.
Flannery Jr RB, LeVitre V, Rego S, Walker AP. Characteristics of staff victims of psychiatric patient assaults: 20-year analysis of the Assaulted Staff Action Program. Psychiatr Q. 2011;82:11–21.CrossRefPubMed
10.
Luciano M, Sampogna G, Del Vecchio V, Pingani L, Palumbo C, De Rosa C, Catapano F, Fiorillo A. Use of coercive measures in mental health practice and its impact on outcome: a critical review. Expert Rev Neurother. 2014;14:131–41.CrossRefPubMed
11.
12.
Steinert T, Lepping P, Bernhardsgrütter R, Conca A, Hatling T, Janssen W, Keski-Valkama A, Mayoral F, Whittington R. Incidence of seclusion and restraint in psychiatric hospitals: a literature review and survey of international trends. Soc Psychiatry Psychiatr Epidemiol. 2010;45:889–97.CrossRefPubMed
13.
Wale JB, Belkin GS, Moon R. Reducing the use of seclusion and restraint in psychiatric emergency and adult inpatient services- improving patient-centered care. Perm J. 2011;15:57–62.CrossRefPubMedPubMedCentral
14.
Salize HJ, Dressing H. Epidemiology of involuntary placement of mentally ill people across the European Union. Br J Psychiatry. 2004;184:163-8.CrossRefPubMed
15.
Bak J, Aggernæs H. Coercion within Danish psychiatry compared with 10 other European countries. Nord J Psychiatry. 2012;66:297–302.CrossRefPubMed
16.
Foster C, Bowers L, Nijman H. Aggressive behavior on acute psychiatric wards: prevalence, severity and management. J Adv Nurs. 2007;58:140–9.CrossRefPubMed
17.
18.
19.
Kontio R, Välimäki M, Putkonen H, Kuosmanen L, Scott A, Joffe G. Patient restrictions: are there ethical alternatives to seclusion and restraint? Nurs Ethics. 2010;17:65–76.CrossRefPubMed
20.
Kontio R, Anttila M, Lantta T, Kauppi K, Joffe G, Välimäki M. Toward a safer working environment on psychiatric wards: service users’ delayed perspectives of aggression and violence-related situations and development ideas. Perspect Psychiatr Care. 2014;50:271–9.CrossRefPubMed
21.
Ling S, Cleverley K, Perivolaris A. Understanding Mental Health Service User Experiences of Restraint Through Debriefing: A Qualitative Analysis. Can J Psychiatry. 2015;60:386–92.CrossRefPubMedPubMedCentral
22.
Van Der Merwe M, Muir-Cochrane E, Jones J, Tziggili M, Bowers L. Improving seclusion practice: implications of a review of staff and patient views. J Psychiatr Ment Health Nurs. 2013;20:203–15.CrossRef
23.
Honkonen H, Mattila AK, Lehtinen K, Elo T, Haataja R, Joukamaa M. Mortality of Finnish acute psychiatric hospital patients. Soc Psychiatry Psychiatr Epidemiol. 2008;43:660–6.CrossRefPubMed
24.
25.
Jungfer HA, Schneeberger AR, Borgwardt S, Walter M, Vogel M, Gairing SK, Lang UE, Huber CG. Reduction of seclusion on a hospital-wide level: successful implementation of a less restrictive policy. J Psychiatr Res. 2014;54:94–9.CrossRefPubMed
26.
Maguire T, Young R, Martin T. Seclusion reduction in a forensic mental health setting. J Psychiatr Ment Health Nurs. 2012;19:97–106.CrossRefPubMed
27.
Putkonen A, Kuivalainen S, Louheranta O, Repo-Tiihonen E, Ryynänen OP, Kautiainen H, Tiihonen J. Cluster-randomized controlled trial of reducing seclusion and restraint in secured care of men with schizophrenia. Psychiatr Serv. 2013;64:850–5.CrossRefPubMed
28.
Steinert T, Eisele F, Goeser U, Tschoeke S, Uhlmann C, Schmid P. Successful interventions on an organisational level to reduce violence and coercive interventions in in-patients with adjustment disorders and personality disorders. Clin Pract Epidemiol Ment Health. 2008;4:27.CrossRefPubMedPubMedCentral
29.
Vruwink FJ, Mulder CL, Noorthoorn EO, Uitenbroek D, Nijman HL. The effects of a nationwide program to reduce seclusion in the Netherlands. BMC Psychiatry. 2012;12:231.CrossRefPubMedPubMedCentral
30.
Cullen A, Clarke A, Kuipers E, Hodgins S, Dean K, Fahy T. A multi-site randomized controlled trial of a cognitive skills programme for male mentally disorder offenders: social-cognitive outcomes. Psychol Med. 2012;42:557–69.CrossRefPubMed
31.
Van de Sande R, Nijman H, Noorthoorn E, Wierdsma A, Hellendoorn E, van der Staak C, Mulder C. Aggression and seclusion on acute psychiatric wards: effect of short-term risk assessment. BMJ. 2011;199:472–8.
32.
Fisher WA. Restraint and seclusion: a review of the literature. Am J Psychiatry. 1994;151:1584–91.CrossRefPubMed
33.
34.
Huf G, Coutinho E, Adams CE. Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (TREC-SAVE): a randomized trial. Psychol Med. 2012;42:2265–73.CrossRefPubMed
35.
Bergk J, Einsiedler B, Flammer E, Steinert T. A Randomized Controlled Comparison of Seclusion and Mechanical Restraint in Inpatient Settings. Psychiatr Serv. 2011;62:1310–7.CrossRefPubMed
36.
Soininen P, Putkonen H, Joffe G, Korkeila J, Puukka P, Pitkänen A, Välimäki M. Does experienced seclusion or restraint affect psychiatric patients’ subjective quality of life at discharge? Int J Ment Health Syst. 2013;7:28.CrossRefPubMedPubMedCentral
37.
Boumans CE, Walvoort SJW, Egger JIM, Hutschemaekers GJM. The Methodical Work Approach and the Reduction in the Use of Seclusion: How did it Work? Psychiatr Q. 2015;86:1–17.CrossRefPubMed
38.
39.
Hoffman T, Erueti C, Galsziou P. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomized trials. BMJ. 2013;347:f3755.CrossRef
40.
Muralidharan S, Fenton M. Containment strategies for people with serious mental illness. Cochrane Database Syst Rev. 2006;3:CD002084.
41.
42.
Bar-Yam Y. Making Things Work: Solving Complex Problems in a Complex World. Cambridge, MA: Necsi Knowledge Press; 2005.
43.
44.
Sailas E, Fenton M. Seclusion and restraint for people with serious mental illnesses. Cochrane Database Syst Rev. 2000;1:CD001163.
45.
46.
Bowers L, James K, Quirk A, Simpson A, SUGAR, Stewart D, Hodsoll J. Reducing conflict and containment rates on acute psychiatric wards: The Safewards cluster randomised controlled trial. Int J Nurs Stud. 2015;52:1412–22.CrossRefPubMedPubMedCentral
47.
Killaspy H, Marston L, Green N, Harrison I, Lean M, Cook S, Mundy T, Craig T, Holloway F, Leavey G, Koeser L, McCrone P, Arbuthnott M, Omar RZ, King M. Clinical effectiveness of a staff training intervention in mental health inpatient rehabilitation units designed to increase patients’ engagement in activities (the Rehabilitation Effectiveness for Activities for Life [REAL] study): single-blind, cluster-randomised controlled trial. Lancet Psychiatry. 2015;2:38–48.CrossRefPubMed
48.
Barrett B, Waheed W, Farrelly S, Birchwood M, Dunn G, Flach C, Henderson C, Leese M, Lester H, Marshall M, Rose D, Sutherby K, Szmukler G, Thornicroft G, Byford S. Randomised controlled trial of joint crisis plans to reduce compulsory treatment for people with psychosis: economic outcomes. PLoS One. 2013;8:e74210.CrossRefPubMedPubMedCentral
49.
Bower P. A cluster randomised controlled trial of the clinical and cost-effectiveness of a ‘whole systems’ model of self-management support for the management of long- term conditions in primary care: trial protocol. Implement Sci. 2012;7:7.CrossRefPubMedPubMedCentral
50.
Mathews C, Eggers SM, Townsend L, Aarø LE, de Vries PJ, Mason-Jones AJ, De Koker P, McClinton Appollis T, Mtshizana Y, Koech J, Wubs A, De Vries H. Effects of PREPARE, a Multi-component, School-Based HIV and Intimate Partner Violence (IPV) Prevention Programme on Adolescent Sexual Risk Behaviour and IPV: Cluster Randomised Controlled Trial. AIDS Behav. 2016;20:1821–40.CrossRefPubMedPubMedCentral
51.
Abderhalden C, Needham I, Dassen T, Halfens R, Haug HJ, Fischer JE. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial. BMJ. 2008;193:44–50.
52.
Thornicroft G, Farrelly S, Szmukler G, Birchwood M, Waheed W, Flach C, Barrett B, Byford S, Henderson C, Sutherby K, Lester H, Rose D, Dunn G, Leese M, Marshall M. Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial. Lancet. 2013;381:1634–41.CrossRefPubMed
53.
Henderson C, Farrelly S, Moran P, Borschmann R, Thornicroft G, Birchwood M, Crimson T, Joshua, Study Groups. Joint crisis planning in mental health care: the challenge of implementation in randomized trials and in routine care. World Psychiatry. 2015;14:281–3.CrossRefPubMedPubMedCentral
54.
Nawaz H, Abbas A, Sarfraz A, Slade MD, Calvocoressi L, Wild DM, Tessier-Sherman B. A randomized clinical trial to compare the use of safety net enclosures with standard restraints in agitated hospitalized patients. J Hosp Med. 2007;2:385–93.CrossRefPubMed
55.
Aakhus E, Granlund I, Odgaard-Jensen J, Oxman AD, Flottorp SA. A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial. Implement Sci. 2016;11:32.CrossRefPubMedPubMedCentral
56.
Slade M, Bird V, Clarke E, Le Boutillier C, McCrone P, Macpherson R, Pesola F, Wallace G, Williams J, Leamy M. Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial. Lancet Psychiatry. 2015;2:503–14.CrossRefPubMed
57.
58.
Krupa T, McLean H, Eastabrook S, Bonham A, Baksh L. Daily time use as a measure of community adjustment for persons served by assertive community treatment teams. Am J Occup Ther. 2003;57:558–65.CrossRefPubMed
59.
Bejerholm U, Eklund M. Time use and occupational performance among persons with schizophrenia. Occup Ther Ment Health. 2004;20:27–46.CrossRef
60.
Cook S, Birrell M. Defining and occupational therapy intervention for people with psychosis. Br J Occup Ther. 2007;70:96–106.CrossRef
61.
Kontio R, Lantta T, Anttila M, Kauppi K, Välimäki M. Family involvement in managing violence of mental health patients. Perspect Psychiatr Care. 2017;53:55–66.
62.
Lantta T, Daffern M, Kontio R, Välimäki M. Implementing the Dynamic Appraisal of Situational Aggression in mental health units. Clin Nurse Spec. 2015;29:230–43.CrossRefPubMed
63.
Lantta T, Anttila M, Kontio R, Adams CE, Välimäki M. Violent events, ward climate and ideas for violence prevention among nurses in psychiatric wards: a focus group study. Int J Ment Health Syst. 2016;10:27.CrossRefPubMedPubMedCentral
64.
Lantta T, Kontio R, Daffern M, Adams CE, Välimäki M. Using the Dynamic Appraisal of Situational Aggression (DASA) with mental health inpatients: a feasibility study. Patient Prefer Adherence. 2016;10:691–701.CrossRefPubMedPubMedCentral
65.
Norman DA, Draper SW, editors. User-Centered System Design: New Perspectives on Human-Computer Interaction. Hillsdale, NJ: Lawrence Earlbaum Associates; 1986.
66.
Abras C, Maloney-Krichmar D, Preece J. User-Centered Design. In: Bainbridge W, editor. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications; 2004. p. 445–56.
67.
Vansteenkiste M, Williams GC, Resnicow K. Toward systematic integration between self-determination theory and motivational interviewing as examples of top-down and bottom-up intervention development: autonomy or volition as a fundamental theoretical principle. Int J Behav Nutr Phys Act. 2012;9:23. doi:10.​1186/​1479-5868-9-23.CrossRefPubMedPubMedCentral
68.
69.
70.
71.
72.
Glasziou P, Haynes B. The paths from research to improved health outcomes. Evid Based Med. 2005;10:4–7.CrossRef
73.
74.
Killaspy H, Cook S, Mundy T, Craig T, Holloway F, Leavey G, Marston L, McCrone P, Koeser L, Arbuthnott M, Omar RZ, King M. Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users’ engagement in activities. BMC Psychiatry. 2013;13:216.CrossRefPubMedPubMedCentral
75.
76.
Anderson NR, West MA. Measuring climate for work group innovation: development and validation of the team climate inventory. J Organ Behav. 1998;19:235–58.CrossRef
77.
Kivimäki M, Kuk G, Elovainio M, Thomson L, Kalliomäki-Levanto T, Heikkilä A. The Team Climate Inventory (TCI)—four or five factors? Testing the structure of TCI in samples of low and high complexity jobs. J Occup Organ Psychol. 1997;70:375–89.CrossRef
78.
Koivunen M, Anttila M, Kuosmanen L, Katajisto J, Välimäki M. Team climate and attitudes toward information and communication technology among nurses on acute psychiatric wards. Inform Health Soc Care. 2015;40:79–90.CrossRefPubMed
79.
Kivimäki M, Elovainio M. A short version of the Team Climate Inventory: Development and psychometric properties. J Occup Organ Psychol. 1999;72:241–6.CrossRef
80.
Endicott J, Spitzer RL, Fleiss JL, Cohen J. The Global Assessment Scale. A Procedure for Measuring Overall Severity of Psychiatric Disturbance. Arch Gen Psychiatry. 1976;33:766–71.CrossRefPubMed
81.
Kuhlman T, Bernstein M, Kloss J, Sincaban V, Harris L. A Team Format for the Global Assessment Scale: Reliability and Validity on an Inpatient Unit. J Pers Assess. 1991;56:335–47.CrossRefPubMed
82.
Attkisson CC, The CSQ. Mill Valley, CA. Tamalpais Matrix Systems LLC: Scales Reprint Portfolio; 2012.
83.
De Wilde EF, Hendriks VM. The Client Satisfaction Questionnaire: psychometric properties in a Dutch addict population. Eur Addict Res. 2005;11:157–62.CrossRefPubMed
84.
Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: A new measure. Psychopharmacol Bull. 1993;29:321–6.PubMed
85.
Pitkänen A, Välimäki M, Endicott J, Katajisto J, Luukkaala T, Koivunen M, Kuosmanen L, Hätönen H. Assessing quality of life in patients with schizophrenia in an acute psychiatric setting: reliability, validity and feasibility of the EQ-5D and the Q-LES-Q. Nord J Psychiatry. 2012;66:19–25.CrossRefPubMed
86.
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009;36:452–7.CrossRefPubMedPubMedCentral
87.
FINLEX 523/1999. Finnish Personal Data Act. Ministry of Social Affairs and Health, Finland. 2001. http://​www.​finlex.​fi/​en/​laki/​kaannokset/​1999/​19990523.​ Accessed 30 Nov 2016.
88.
Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. The World Health Organization (WHO). Geneva: WHO; 2002.
89.
90.
Nijman HL, Merckelbach HL, Allertz WF, Campo JM a. Prevention of aggressive incidents on a closed psychiatric ward. Psychiatr Serv. 1997;48:694–8.CrossRefPubMed
91.
Kjellin L, Westrin CG. Involuntary admissions and coercive measures in psychiatric care. Registered and reported. Int J Law Psychiatry. 1998;21:31–42.CrossRefPubMed
92.
Hintze J. PASS 11. NCSS, LLC. Kaysville, Utah, USA. 2011. www.ncss.com. Accessed 30 Nov 2016.
93.
Trivedi RB, Szarka JG, Beaver K, Brousseau K, Nevins E, Yancy Jr WS, Slade A, Voils CI. Recruitment and retention rates in behavioral trials involving patients and a support person: a systematic review. Contemp Clin Trials. 2013;36:307–18.CrossRefPubMed
94.
95.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
96.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.CrossRef
97.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349–57.CrossRefPubMed
98.
99.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed
Metadata
Title
Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services
Authors
Maritta Välimäki
Min Yang
Sharon-Lise Normand
Kate R. Lorig
Minna Anttila
Tella Lantta
Virve Pekurinen
Clive E. Adams
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2017
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-017-1266-6

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