Opposition to Diagnostic or Therapeutic Procedures by Age... | NCT03373838

Studies
Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient

NCT03373838

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Dec 11, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Aging
Refusal, Treatment
Qualitative Research
Epidemiology

Interventions

Census

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2018Actual

Primary Completion Date

Jun 25, 2020Actual

Completion Date

Dec 10, 2020Actual

First Submitted Date

Nov 22, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas TANNOU, Medical Doctor, Centre Hospitalier Universitaire de BesanconPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Census		Epidemiological study. Sociodemographic and medical survey.	Other: Census
Qualitative interview		Individual qualitative interview.	Other: Census

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Census	Other	Survey and interview	Census Qualitative interview

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Regis AUBRY, MD/PhD	CHU DE BESANCON	Study Chair
Thomas TANNOU, MD	CHU DE BESANCON	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire		Besançon		25000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33308277	Derived	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.

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
D003710	Demography
D011154	Population Characteristics
D015991	Epidemiologic Measurements
D011634	Public Health