Shared Decision Making in a General Hospital

Shared Decision Making in Patients With Surgical or Non-Surgical Diseases in a General Hospital: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; General Medical Condition
• Intervention / Treatment: Procedure: Any appropriate surgical treatment; Drug: Any appropriate drug or non-drug treatment excluding surgery

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Greece
  • Elefsína, Greece, 19600
    • Thriassion General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical Disorders; A. Surgical Disorders: Current Hospitalization at the Surgical Inpatient Department or at the Inpatient Department of Otorhinolaryngology or at the Inpatient Department of Cardiology OR; Current Follow-up at the Surgical Outpatient Department or at the Outpatient Department of Otorhinolaryngology or at the Outpatient Department of Cardiology due to a disorder for which any appropriate surgical treatment (surgery) is a treatment option.	Procedure: Any appropriate surgical treatment; Any appropriate surgical treatment for the management of patient's current disorder
Non-Surgical General Medical Disorders; Current Hospitalization at the Internal Medicine Inpatient Department or at the Inpatient Department of Cardiology OR; Current Follow-up at the Internal Medicine Outpatient Department or at the Outpatient Department of Cardiology due to a disorder for which surgery is not a treatment option and any appropriate drug or non-drug treatment excluding surgery is a treatment option.	Drug: Any appropriate drug or non-drug treatment excluding surgery; Any appropriate drug or non-drug treatment excluding surgery for the management of patient's current disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders	Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores	Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores	one year
Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores	Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores	one year
Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores	Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores	one year
Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores	Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores	one year

Collaborators and Investigators

• Sponsor: Psychiatric Hospital of Attica
• Collaborators: Thriassio General Hospital of Elefsina
• Investigators: Study Director: Dimitrios Kontis, MD, PHD, Psychiatric Hospital of Attica

Publications and helpful links

General Publications

• 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.
• Taking shared decision making more seriously. Lancet. 2011 Mar 5;377(9768):784. doi: 10.1016/S0140-6736(11)60290-0. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 24, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PsychiatricHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No