Shared Decision Making in a General Hospital

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537352
• Other study ID #: PsychiatricHA
• Status: Completed
• Start date: May 14, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: November 2018
• Source: Psychiatric Hospital of Attica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• General Medical Condition
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Any appropriate surgical treatment
Any appropriate surgical treatment for the management of patient's current disorder

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

Locations

Country	Name	City	State
Greece	Thriassion General Hospital	Elefsína

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric Hospital of Attica	Thriassio General Hospital of Elefsina

Country where clinical trial is conducted

Greece, 

References & Publications (10)

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. Review. — View Citation

De Las Cuevas C, Peñate W, Perestelo-Pérez 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. — View 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. Epub 2006 May 11. — View Citation

Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter 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. — View 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. — View 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. Review. — View Citation

Schneider A, Körner 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. — View Citation

Smith GL, Volk RJ. Nonclinical Factors Affecting Shared Decision Making. JAMA. 2017 Jul 25;318(4):391. doi: 10.1001/jama.2017.7841. — View Citation

Stacey D, Légaré 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. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431. — View Citation

Taking shared decision making more seriously. Lancet. 2011 Mar 5;377(9768):784. doi: 10.1016/S0140-6736(11)60290-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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