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Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient (OPTAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373838
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas TANNOU, Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:
The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

Condition or disease Intervention/treatment
Aging Refusal, Treatment Qualitative Research Epidemiology Other: Census

Detailed Description:
To complete qualitative study, interview will also be conducted with : patients, general practitioner, relative and home carers. An observation of geriatric multidisciplinary staff will be done for better understanding of complexity.
Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : June 25, 2020
Actual Study Completion Date : December 10, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Census
Epidemiological study. Sociodemographic and medical survey.
 Other: Census
Survey and interview
Other Name: Qualitative study
Qualitative interview
Individual qualitative interview.
 Other: Census
Survey and interview
Other Name: Qualitative study


Outcome Measures
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Primary Outcome Measures :
  1. 30 individual semi-structured interviews [ Time Frame: 1 year ]
    Qualitative data analysis and theorical saturation


Secondary Outcome Measures :
  1. 100 demographic survey [ Time Frame: 1 year ]
    Statistical analysis

  2. 100 medical survey [ Time Frame: 1 year ]
    Statistical analysis


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patient presenting opposition to medical or diagnosis procedure define as :

  • Repeated expression (at least 2 times to 2 differents professionnals) without agreed between these 2 oppositions.
  • Concerning : medication, invasive diagnosis procedure or withdrawal of catheter.
Criteria

Inclusion Criteria:

  • geriatric department inpatient.
  • presenting opposition to medical or diagnosis procedure
  • covered by French Social Security System
  • agreed to participate to the study

Exclusion Criteria:

  • They did not express himself an opposition
  • They disagree to participated
  • For qualitative research only : major neurocognitive disorder (MMSE <10).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373838


Locations
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France
Centre Hospitalier Universitaire
Besancon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Study Chair: Regis AUBRY, MD/PhD CHU de Besancon
Principal Investigator: Thomas TANNOU, MD CHU de Besancon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas TANNOU, Medical Doctor, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03373838    
Other Study ID Numbers: P/2017/349
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No