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Completed

NCT Number: NCT03537352

Shared Decision Making in a General Hospital

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Thriassion General Hospital

Elefsina, 19600, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Any appropriate surgical treatment

Procedure

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

Any appropriate drug or non-drug treatment excluding surgery

Drug

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

Primary outcomes

  1. Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders

    Time frame: one year

    Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders

Secondary outcomes

  1. Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores

    Time frame: one year

    Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores

  2. Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores

    Time frame: one year

    Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores

  3. Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores

    Time frame: one year

    Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores

  4. Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores

    Time frame: one year

    Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores

Sponsors and collaborators

Lead sponsor

Psychiatric Hospital of Attica

Other

Collaborators

  • Thriasio General Hospital of Elefsina

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 25, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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