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

December 10, 2020 updated by: Thomas TANNOU, Centre Hospitalier Universitaire de Besancon

Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

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

  • France
      • Besancon, France, 25000
        • Centre Hospitalier Universitaire

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

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Census
Epidemiological study. Sociodemographic and medical survey.
Other: Census
Survey and interview
Other Names:
  • Qualitative study
Qualitative interview
Individual qualitative interview.
Other: Census
Survey and interview
Other Names:
  • Qualitative study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 individual semi-structured interviews
Time Frame: 1 year
Qualitative data analysis and theorical saturation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100 demographic survey
Time Frame: 1 year
Statistical analysis
1 year
100 medical survey
Time Frame: 1 year
Statistical analysis
1 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Chair: Regis AUBRY, MD/PhD, CHU de Besancon
  • Principal Investigator: Thomas TANNOU, MD, CHU de Besancon

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)

January 5, 2018

Primary Completion (Actual)

June 25, 2020

Study Completion (Actual)

December 10, 2020

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • P/2017/349

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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