Shared decision making PLUS - a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS).

Publisher: BioMed Central Country of Publication: England NLM ID: 100968559 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-244X (Electronic) Linking ISSN: 1471244X NLM ISO Abbreviation: BMC Psychiatry Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Clinical Protocols* ; Decision Making* ; Patient Participation* ; Schizophrenic Psychology*; Inpatients/*psychology; Adolescent ; Adult ; Aged ; Communication ; Female ; Humans ; Male ; Medication Adherence ; Middle Aged ; Psychotic Disorders/therapy ; Recurrence ; Schizophrenia/therapy ; Young Adult

Background: Shared decision making (SDM) is a model of how doctors and patients interact with each other. It aims at changing the traditional power asymmetry between doctors and patients by strengthening the exchange of information and the decisional position of the patient. Although SDM is generally welcomed by mental health patients as well as by mental health professionals its implementation in routine care, especially in the more acute settings, is still lacking. SDM-PLUS has been developed as an approach that addresses both patients and mental health professionals and aims at implementing SDM even for the very acutely ill patients.
Methods: The SDM-PLUS study will be performed as a matched-pair cluster-randomized trial in acute psychiatric wards. On wards allocated to the intervention group personnel will receive communication training (addressing how to implement SDM for various scenarios) and patients will receive a group intervention addressing patient skills for SDM. Wards allocated to the control condition will continue treatment as usual. A total sample size of 276 patients suffering from schizophrenia or schizoaffective disorder on 12 wards is planned. The main outcome parameter will be patients' perceived involvement in decision making during the inpatient stay measured with the SDM-Q-9 questionnaire. Secondary objectives include the therapeutic relationship and long term outcomes such as medication adherence and rehospitalization rates. In addition, process measures and qualitative data will be obtained to allow for the analysis of potential barriers and facilitators of SDM-PLUS. The primary analysis will be a comparison of SDM-Q-9 sum scores 3 weeks after study inclusion (or discharge, if earlier) between the intervention and control groups. To assess the effect of the intervention on this continuous primary outcome, a random effects linear regression model will be fitted with ward (cluster) as a random effect term and intervention group as a fixed effect.
Discussion: This will be the first trial examining the SDM-PLUS approach for patients with schizophrenia or schizoaffective disorder in very acute mental health inpatient settings. Within the trial a complex intervention will be implemented that addresses both patients and health care staff to yield maximum effects.
Trial Registration: German Clinical Trials Register DRKS00010880 . Registered 09 August 2016.

PLoS One. 2015 Jul 07;10(7):e0132158. (PMID: 26151946)
J Gen Intern Med. 1989 Jan-Feb;4(1):23-30. (PMID: 2644407)
BMJ. 1999 Sep 18;319(7212):766-71. (PMID: 10488010)
Community Ment Health J. 2013 Apr;49(2):185-92. (PMID: 22837104)
Psychiatr Serv. 2009 Aug;60(8):1007. (PMID: 19648184)
Br J Gen Pract. 1999 Jun;49(443):477-82. (PMID: 10562751)
Acta Psychiatr Scand. 2006 Oct;114(4):265-73. (PMID: 16968364)
Psychother Psychosom. 2011;80(2):70-7. (PMID: 21196804)
Psychiatr Serv. 2013 May 1;64(5):416-22, 416.e1-3. (PMID: 23318707)
Psychiatr Serv. 2011 Oct;62(10 ):1218-21. (PMID: 21969650)
J Med Internet Res. 2013 Oct 07;15(10):e216. (PMID: 24100091)
Patient Educ Couns. 2013 Jun;91(3):326-8. (PMID: 23414657)
Psychiatr Serv. 2014 Dec 1;65(12):1483-6. (PMID: 25756970)
Int J Soc Psychiatry. 2014 May;60(3):227-35. (PMID: 23632272)
Patient Educ Couns. 2010 Jul;80(1):94-9. (PMID: 19879711)
Psychother Psychosom Med Psychol. 1995 Sep-Oct;45(9-10):351-7. (PMID: 7480592)
Schizophr Res. 2000 May 5;42(3):241-7. (PMID: 10785582)
Epidemiol Psychiatr Sci. 2016 Feb;25(1):69-79. (PMID: 25600424)
Acta Psychiatr Scand. 1994 Jan;89(1):62-7. (PMID: 7908156)
Patient Educ Couns. 2007 Aug;67(3):324-32. (PMID: 17509808)
Psychiatr Serv. 2009 Aug;60(8):1107-12. (PMID: 19648199)
Med Care. 2009 Aug;47(8):826-34. (PMID: 19584762)
BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488)
PLoS One. 2012;7(4):e36080. (PMID: 22558336)
J Nerv Ment Dis. 2008 Apr;196(4):329-32. (PMID: 18414128)
Curr Opin Psychiatry. 2014 May;27(3):222-9. (PMID: 24613981)
Psychiatry Res. 2011 Aug 15;188(3):456-8. (PMID: 21624684)
BMJ. 2007 Mar 3;334(7591):455-9. (PMID: 17332585)
Z Evid Fortbild Qual Gesundhwes. 2009;103(7):475-80. (PMID: 19839536)
Patient Educ Couns. 2008 Dec;73(3):526-35. (PMID: 18752915)
Soc Sci Med. 1997 Mar;44(5):681-92. (PMID: 9032835)
Eur Neuropsychopharmacol. 2014 Sep;24(9):1506-10. (PMID: 25037772)
Patient Educ Couns. 2012 Aug;88(2):284-90. (PMID: 22480628)
Soc Sci Med. 2006 Jun;62(11):2861-73. (PMID: 16343722)
Soc Psychiatry Psychiatr Epidemiol. 2016 Apr;51(4):617-25. (PMID: 26155899)
Neuropsychiatr Dis Treat. 2013;9:1045-52. (PMID: 23950646)
J Clin Psychiatry. 2007 Jul;68(7):992-7. (PMID: 17685733)

Keywords: Adherence; Schizophrenia; Shared decision making

DRKS DRKS00010880

Date Created: 20170225 Date Completed: 20170707 Latest Revision: 20181202

20240105

PMC5324213

10.1186/s12888-017-1240-3

28231777