AzTrials
AzTrials

The Patient's Ability to Decide to Return Home After HospitalizationDROM-testNCT06669559

A Clinical Decision Support Tool for Assessing the Ability to Decide on Returning Home in Elderly Patients with Cognitive Impairments

A study testing DROM-Test in people with The Patient's Ability to Decide to Return Home After Hospitalization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

No validated and generalized tool for assessing a patient's ability to decide whether to return home after hospitalization exists. Evaluating the capacity of elderly patients to decide on their own return home is a daily concern for geriatricians. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
DROM-Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
1 siteFrance
Study dates
Jan 2025to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 70 years and over
  • neurocognitive disorders regardless of diagnosis
  • MMSE between 15 and 25
  • hospitalized in geriatrics
  • still living at home at the time of hospitalization
  • affiliated to or beneficiary of a social security scheme
Show all 15Show fewer
  • Non-inclusion criteria
  • confusional episode,
  • palliative care,
  • presence of another significant or systemic pathology: Cerebral Vascular Accident < 3 months, oncological pathology during treatment, decompensated psychiatric illness, acute organ failure,
  • total visual or hearing deficit,
  • has already taken the DROM test during a previous hospitalization,
  • language barrier,
  • refusal of participation by the patient, their relative or guardian if applicable
  • patient under judicial protection

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Hôpital Bretonneau

    Paris, 75018

    Mouna Romdhani, MD, 0616317954 ext. +33, mouna.romdhani@aphp.fr

Other trials in France

About this study

Official title: DROM Test, a Clinical Decision Support Tool for Assessing the Ability to Decide on Returning Home in Elderly Patients with Cognitive Impairments

No validated and generalized tool for assessing a patient's ability to decide whether to return home after hospitalization exists. Evaluating the capacity of elderly patients to decide on their own return home is a daily concern for geriatricians. Neurocognitive disorders do not necessarily mean an inability to decide and the MMSE (mini mental state examination), a reference scale for screening neurocognitive disorders, is not sufficient to determine decision-making capacity apart from extreme scores. Depending on the stage or type of neurocognitive disorders, the same stages of the decision-making process (understanding, reasoning, appreciation, choice) are not impacted. The ability to decide depends on the type of decision (deciding to vote, deciding to take a medication, to participate in clinical research, etc.), i.e. domain-dependent. Associating the clinician's clinical decision with a standardized tool for assessing patients' capacity to decide would enable more ethical clinical practice.

the aim of the study is to add to the clinical decision a decision support tool to assess the capacity to decide whether to return home has better sensitivity in the assessment of the capacity to decide than that of clinical assessment alone

Read the detailed description

To date, there is no curative treatment for neuro-progressive diseases and it has been shown that cognitive assessment tests such as the MMSE (mini mental state examination) are not sufficient to assess the ability to decide a patient with a neurocognitive disorder.

Evaluating the capacity of elderly patients to decide on their own return home is a daily concern for geriatricians. Indeed, patients with neurocognitive disorders are often forced to be institutionalized without anyone being certain of their inability to decide. 43% of people hospitalized for a short geriatric stay have a neurocognitive disorder linked to Alzheimer's disease. Despite these disorders, it is absolutely necessary to respect the fundamental ethical principles of medical practice and thus the autonomy of the patient. The legal capacity and choice of place of life by the person with or without a disability are protected by international institutions (United Nations (UN), Convention on the Rights of Persons with Disabilities, article 19) and regulated by law, even for patients under legal protection. Neurocognitive disorders do not necessarily mean an inability to decide and the MMSE, the reference scale for screening neurocognitive disorders, is not sufficient to determine decision-making capacity apart from extreme scores. Depending on the stage or type of neurocognitive disorders, the same stages of the decision-making process (understanding, reasoning, appreciation, choice) are not impacted.

The ability to decide depends on the type of decision (deciding to vote, deciding to take medication, participating in clinical research, etc.) or domain-dependent. Currently, the assessment of the ability to decide to return home is carried out by clinicians according to clinical assessment without a specific standardized tool. The variability between evaluators turns out to be very important, specifically identified in the process of being able to decide to take a treatment. Associating the clinician's clinical decision with a standardized tool for evaluating patients' capacity to decide allows for more ethical clinical practice.

No validated and generalized tool for assessing the patient's ability to decide whether to return home after hospitalization exists.

Following this observation, the DROM-test tool (DReam of hOMe), developed within the neuro-psychogeriatrics department of Bretonneau Hospital (102 patients, average age 83 years, average MMSE of 20) allowed to objectify the choice dimension among these four dimensions (understanding, reasoning, appreciation, choice). The performance of the DROM test must now be evaluated on a multicenter scale using an independent expert as the gold standard.

The objective is not to replace the clinical decision but to provide a tool allowing the clinician in his daily practice to argue the decision-making capacity and thus improve the care pathway by increasing the rate of agreement between the clinician and the patient. Failure to return home is often felt as an injustice by patients, providing support for understanding their situation can improve the experience of the situation.

Adding a decision support tool to the clinical decision to assess the capacity to decide whether to return home has better sensitivity in the assessment of the capacity to decide than that of clinical assessment alone.

The population to be studied will be made up of patients with a moderate neurocognitive disorder, a population for which the question of the ability to decide frequently arises, particularly when the patient still lives at home and is weakened by hospitalization. The question of returning home is essential for these patients for whom being sent to a retirement home is experienced as an injustice because it is a non-choice, sometimes even without having been consulted.

The DROM test: The elements of the DROM-test are detailed in the reference publication: 8 questions (understanding, appreciation, choice dimensions) and 4 clinical vignettes (reasoning, choice dimensions) each comprising 3 questions with a binary response.

Its structure includes a questionnaire part and a clinical vignette part improving patients' understanding. Its hetero-questionnaire format, its short administration time (10 min) and its simple instructions make it a tool that could be easily distributed in services receiving elderly people with neurocognitive disorders.

It was improved by taking into account the results of the initial study then after modification, it will be tested on 10 patients from the neuropsychogeriatrics department of Bretonneau hospital in order to reassess the good understanding and consistency of the test.

The DROM-test is given to the patient by their referring doctor. The detailed medical certificate of non-return home: It is a medical certificate produced by an expert doctor registered with a judicial court in France which aims to medically evaluate the capacity of a patient to return home. Usually this certificate is produced for protected adults and sent to the guardianship judge who subsequently decides on any act of disposition of the accommodation.

In this study, it is considered the Gold Standard because the only legally accepted document for this type of evaluation. It will be produced but not sent to court.

Being tested
DROM-Test
Keywords
decision making capacity, dementia, to return home, elderly, capacity assessment
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DROM-TestOther

    DROM test: a tool for assessing the ability to decide on returning home

Study groups in NCT06669559
Study groupRoleWhat they receive
Person aged 70 and over with a neurocognitive disorder and hospitalized in geriatricsOtherNot described
Receives: Other: DROM-Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of the DROM test

    Ability of the DROM test to accurately identify true positives, meaning patients who truly have the capacity to decide on returning home, according to the gold standard

    Measured: 3 days

Secondary outcomes (12)
  1. Specificity of the DROM test

    Ability of the DROM test to accurately identify true negatives.

    Measured: 3 days

  2. Kappa coefficient of agreement between the initial judgment of the referring physician and their judgment after reviewing the patient's results from the DROM test

    Measured: 3 days

  3. Percentage of agreement between the clinician and the patient before DROM test

    Measured: 3 days

  4. Percentage of agreement between the clinician and the patient after DROM test

    Measured: 3 days

  5. Percentage of patients who completed the DROM test among those who are eligible

    Measured: 1 year

  6. Percentage of test adherence by patients

    Measured: 1 year

  7. Percentage of patients who complete the test.

    Measured: 1 year

  8. Average test duration in minutes

    Measured: 1 year

  9. Clinician's perception evaluation with the use of the DROM test using a 4-question, 5-point Likert scale (from completely useful to completely useless)

    Measured: 1 year

  10. Patient's perception evaluation using a 4-question, 5-point Likert scale

    Measured: 1 year

  11. Description of the factors associated with patients not returning home

    Measured: 1 year

  12. Optimal DROM-test threshold to identify patients most likely to demonstrate decisional incapacity

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669559
Sponsor's protocol ID
APHP240159
Other IDs
2024-A01838-39
Acronym
DROM-test
Status last verified
Oct 2024
First submitted
30 Oct 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing DROM-Test in people with The Patient's Ability to Decide to Return Home After Hospitalization, run by Assistance Publique - Hôpitaux de Paris 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 15 inclusion and 0 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: opening soon, as of the sponsor's last update on 1 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mouna Romdhani, MD (0616317954 ext. +33, mouna.romdhani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of the DROM test (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Nov 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in