AgingOPTAHNCT03373838
Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient
An observational study of Aging and Refusal, Treatment, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aging, Refusal, Treatment, Qualitative Research
- What is being tested?
- Census
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2018to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- geriatric department inpatient.
- presenting opposition to medical or diagnosis procedure
- covered by French Social Security System
- agreed to participate to the study
Who cannot join
- They did not express himself an opposition
- They disagree to participated
- For qualitative research only : major neurocognitive disorder (MMSE <10).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Aging, Refusal, Treatment, Qualitative Research, Epidemiology
- Being tested
- Census
- Medical subject headings
- Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CensusOther
Also called Qualitative study
Survey and interview
| Study group | Role | What they receive |
|---|---|---|
| Census | Epidemiological study. Sociodemographic and medical survey. Receives: Other: Census | |
| Qualitative interview | Individual qualitative interview. Receives: Other: Census |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 individual semi-structured interviews
Qualitative data analysis and theorical saturation
Measured: 1 year
Secondary outcomes (2)
100 demographic survey
Statistical analysis
Measured: 1 year
100 medical survey
Statistical analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start5 Jan 2018
- Primary completion25 Jun 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas TANNOU, Centre Hospitalier Universitaire de Besancon
- Investigators
- Regis AUBRY, MD/PhD, Study chair, CHU DE BESANCONThomas TANNOU, MD, Principal investigator, CHU DE BESANCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373838
- Sponsor's protocol ID
- P/2017/349
- Acronym
- OPTAH
- Status last verified
- Dec 2020
- First submitted
- 22 Nov 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.
- ClinicalTrials.gov ID
- NCT03373838
- Acronym / sponsor ID
- OPTAH / P/2017/349
- Conditions
- Aging, Refusal, Treatment, Qualitative Research, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Census | – | Other: CensusEpidemiological study. Sociodemographic and medical survey. |
| Qualitative interview | – | Other: CensusIndividual qualitative interview. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- geriatric department inpatient.
- presenting opposition to medical or diagnosis procedure
- covered by French Social Security System
- agreed to participate to the study
Key exclusion criteria (3 listed)
- They did not express himself an opposition
- They disagree to participated
- For qualitative research only : major neurocognitive disorder (MMSE <10).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CensusAlso: Qualitative studySurvey and interview | Other | Census, Qualitative interview |
Primary outcome
30 individual semi-structured interviews
Time frame: 1 year
Qualitative data analysis and theorical saturation
2 secondary outcomes
100 demographic survey
Time frame: 1 year
100 medical survey
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 33308277Tannou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regis AUBRY, MD/PhD study chair
CHU DE BESANCON
Thomas TANNOU, MD principal investigator
CHU DE BESANCON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Refusal, Treatment, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 individual semi-structured interviews (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.