Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient
OPTAH
1 other identifier
observational
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedStudy Start
First participant enrolled
January 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2020
CompletedDecember 11, 2020
December 1, 2020
2.5 years
November 22, 2017
December 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
30 individual semi-structured interviews
Qualitative data analysis and theorical saturation
1 year
Secondary Outcomes (2)
100 demographic survey
1 year
100 medical survey
1 year
Study Arms (2)
Census
Epidemiological study. Sociodemographic and medical survey.
Qualitative interview
Individual qualitative interview.
Interventions
Eligibility Criteria
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.
You may qualify if:
- geriatric department inpatient.
- presenting opposition to medical or diagnosis procedure
- covered by French Social Security System
- agreed to participate to the study
You may not qualify if:
- They did not express himself an opposition
- They disagree to participated
- For qualitative research only : major neurocognitive disorder (MMSE \<10).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire
Besançon, 25000, France
Related Publications (1)
Tannou T, Trimaille H, Mathieu-Nicot F, Koeberle S, Aubry R, Godard-Marceau A. Investigation of opposition to diagnostic or therapeutic procedures in older people hospitalized in acute geriatric services: the OPTAH pilot study protocol. Pilot Feasibility Stud. 2020 Dec 14;6(1):194. doi: 10.1186/s40814-020-00742-7.
PMID: 33308277DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Regis AUBRY, MD/PhD
CHU DE BESANCON
- PRINCIPAL INVESTIGATOR
Thomas TANNOU, MD
CHU DE BESANCON
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
November 22, 2017
First Posted
December 14, 2017
Study Start
January 5, 2018
Primary Completion
June 25, 2020
Study Completion
December 10, 2020
Last Updated
December 11, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share