Clinical trial NCT03537352: Shared Decision Making in a General Hospital
Official title: Shared Decision Making in Patients With Surgical or Non-Surgical Diseases in a General Hospital: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
General Medical Condition
Lead sponsor: Psychiatric Hospital of Attica
Sponsor class: OTHER
Collaborators: name: Thriasio General Hospital of Elefsina
First posted: 2018-05-25
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in 4 acute wards (2 for surgical and 2 for non-surgical disorders) or the relevant outpatient departments

Brief summary: A pilot cross-sectional study will investigate the differential effect of the type of disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making questionnaire.

Detailed description: During a pilot cross-sectional study, the 9- Item Shared Decision Making Questionnaire (9SDMQ) will be administered in two groups of participants, one (N=60) suffering from surgical diseases and one (N=60) from non-surgical medical diseases. Patients hospitalized in four acute wards (2 surgical and 2 non-surgical wards) or visiting the relevant outpatient departments of the Triassion General Hospital of Elefsina, Greece will be recruited. The primary outcome will be the difference on the 9SDMQ scores (transformed in a 1-100% scale) in patients suffering from surgical versus non-surgical disorders. Secondary outcome measures will include the effect of patients' demographic and clinical variables, of physicians' demographic variables and of the score on the Montreal Cognitive Assessment on the 9SDMQ scores. Additionally the relationship of patients' satisfaction on the 9SDMQ scores will also be investigated.

Eligibility criteria: Inclusion Criteria:

* Hospitalization in the Thriassion General Hospital of Elefsina
* Ability to give informed consent

Exclusion Criteria:

* Inability to complete the neuropsychological assessment
* Mental retardation

Primary outcomes:
measure: Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders
timeFrame: one year
Secondary outcomes:
measure: Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores
timeFrame: one year
measure: Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores
timeFrame: one year
measure: Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores
timeFrame: one year
measure: Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores
timeFrame: one year
Other outcomes:
Locations:
city: Elefsína
country: Greece
facility: Thriassion General Hospital
Study officials:
affiliation: Psychiatric Hospital of Attica
name: Dimitrios Kontis, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Taking shared decision making more seriously. Lancet. 2011 Mar 5;377(9768):784. doi: 10.1016/S0140-6736(11)60290-0. No abstract available.
citation: Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
citation: De Las Cuevas C, Penate W, Perestelo-Perez L, Serrano-Aguilar P. Shared decision making in psychiatric practice and the primary care setting is unique, as measured using a 9-item Shared Decision Making Questionnaire (SDM-Q-9). Neuropsychiatr Dis Treat. 2013;9:1045-52. doi: 10.2147/NDT.S49021. Epub 2013 Jul 30.
citation: Flynn KE, Smith MA, Vanness D. A typology of preferences for participation in healthcare decision making. Soc Sci Med. 2006 Sep;63(5):1158-69. doi: 10.1016/j.socscimed.2006.03.030. Epub 2006 May 11.
citation: Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
citation: Mah HC, Muthupalaniappen L, Chong WW. Perceived involvement and preferences in shared decision-making among patients with hypertension. Fam Pract. 2016 Jun;33(3):296-301. doi: 10.1093/fampra/cmw012. Epub 2016 Mar 18.
citation: Pollard S, Bansback N, Bryan S. Physician attitudes toward shared decision making: A systematic review. Patient Educ Couns. 2015 Sep;98(9):1046-57. doi: 10.1016/j.pec.2015.05.004. Epub 2015 May 23.
citation: Schneider A, Korner T, Mehring M, Wensing M, Elwyn G, Szecsenyi J. Impact of age, health locus of control and psychological co-morbidity on patients' preferences for shared decision making in general practice. Patient Educ Couns. 2006 May;61(2):292-8. doi: 10.1016/j.pec.2005.04.008.
citation: Smith GL, Volk RJ. Nonclinical Factors Affecting Shared Decision Making. JAMA. 2017 Jul 25;318(4):391. doi: 10.1001/jama.2017.7841. No abstract available.
citation: Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.