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CompletedNCT03373838OPTAHUpdated Dec 11, 2020

Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient

An observational study in Aging, Refusal, Treatment and Qualitative Research, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2020-12-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
35
Ages
75 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Aging
  • Refusal, Treatment
  • Qualitative Research
  • Epidemiology

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03

In context

Treatment Refusal

28 studies on the registry are indexed under Treatment Refusal; 6 are open to participants now.

This study's enrollment of 35 is below the median of 188 across 13 observational studies indexed under Treatment Refusal.

Browse Treatment Refusal studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • They did not express himself an opposition
  • They disagree to participated
  • For qualitative research only : major neurocognitive disorder ( \<10).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • Census

    Epidemiological study. Sociodemographic and medical survey.

    Other: Census

  • Qualitative interview

    Individual qualitative interview.

    Other: Census

Interventions

  • OtherCensus

    Survey and interview

    Also known as: Qualitative study

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What researchers measure

Primary outcomes

  1. 30 individual semi-structured interviews

    Qualitative data analysis and theorical saturation

    Time frame: 1 year

Secondary outcomes

  1. 100 demographic survey

    Statistical analysis

    Time frame: 1 year

  2. 100 medical survey

    Statistical analysis

    Time frame: 1 year

07

Study locations

1 site
  • Centre Hospitalier Universitaire
    Besancon, 25000, France
08

References and documents

Publications

  • 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. PubMed 33308277 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03373838
Responsible party
Thomas TANNOU (Medical Doctor, Centre Hospitalier Universitaire de Besancon) — Principal investigator
First posted
Dec 14, 2017
Start date
Jan 5, 2018
Primary completion
Jun 25, 2020
Completion
Dec 10, 2020
Last update
Dec 11, 2020

Study contacts

Regis AUBRY, MD/PhD
study chair · CHU DE BESANCON
Thomas TANNOU, MD
principal investigator · CHU DE BESANCON

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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