NCT03537352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

May 15, 2018

Last Update Submit

November 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    one year

  • 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

    one year

Study Arms (2)

Surgical Disorders

A. Surgical Disorders: 1. Current Hospitalization at the Surgical Inpatient Department or at the Inpatient Department of Otorhinolaryngology or at the Inpatient Department of Cardiology OR 2. 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

Non-Surgical General Medical Disorders

1. Current Hospitalization at the Internal Medicine Inpatient Department or at the Inpatient Department of Cardiology OR 2. 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

Interventions

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

Surgical Disorders

Any appropriate drug or non-drug treatment excluding surgery for the management of patient's current disorder

Non-Surgical General Medical Disorders

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in 4 acute wards (2 for surgical and 2 for non-surgical disorders) or the relevant outpatient departments

You may qualify if:

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

You may not qualify if:

  • Inability to complete the neuropsychological assessment
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thriassion General Hospital

Elefsina, 19600, Greece

Location

Related Publications (10)

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

    PMID: 21377556BACKGROUND
  • 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.

    PMID: 21474265BACKGROUND
  • 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.

    PMID: 23950646BACKGROUND
  • 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.

    PMID: 16697096BACKGROUND
  • 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.

    PMID: 19879711BACKGROUND
  • 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.

    PMID: 26993483BACKGROUND
  • 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.

    PMID: 26138158BACKGROUND
  • 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.

    PMID: 15896943BACKGROUND
  • 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.

    PMID: 28742899BACKGROUND
  • 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.

    PMID: 24470076BACKGROUND

Study Officials

  • Dimitrios Kontis, MD, PHD

    Psychiatric Hospital of Attica

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Head, 4th Psychiatric Department

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

May 14, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations