Shared Decision Making in a General Hospital

November 24, 2018 updated by: Dimitrios Kontis, Psychiatric Hospital of Attica

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Any appropriate surgical treatment for the management of patient's current disorder
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
one year
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
one year
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
one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psychiatric Hospital of Attica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Thriassio General Hospital of Elefsina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dimitrios Kontis, MD, PHD, Psychiatric Hospital of Attica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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