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.
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
- Conditions the study is for
- The Patient's Ability to Decide to Return Home After Hospitalization
- 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
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- 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
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 group | Role | What they receive |
|---|---|---|
| Person aged 70 and over with a neurocognitive disorder and hospitalized in geriatrics | Other | Not described Receives: Other: DROM-Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Specificity of the DROM test
Ability of the DROM test to accurately identify true negatives.
Measured: 3 days
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
Percentage of agreement between the clinician and the patient before DROM test
Measured: 3 days
Percentage of agreement between the clinician and the patient after DROM test
Measured: 3 days
Percentage of patients who completed the DROM test among those who are eligible
Measured: 1 year
Percentage of test adherence by patients
Measured: 1 year
Percentage of patients who complete the test.
Measured: 1 year
Average test duration in minutes
Measured: 1 year
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
Patient's perception evaluation using a 4-question, 5-point Likert scale
Measured: 1 year
Description of the factors associated with patients not returning home
Measured: 1 year
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.
- First posted1 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patient's Ability to Decide to Return Home After HospitalizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouna Romdhani, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DROM Test, a Clinical Decision Support Tool for Assessing the Ability to Decide on Returning Home in Elderly Patients with Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06669559
- Acronym / sponsor ID
- DROM-test / APHP240159
- Keywords
- decision making capacity, dementia, to return home, elderly, capacity assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person aged 70 and over with a neurocognitive disorder and hospitalized in geriatrics | Other | Other: DROM-Test |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DROM-TestDROM test: a tool for assessing the ability to decide on returning home | Other | Person aged 70 and over with a neurocognitive disorder and hospitalized in geriatrics |
Primary outcome
Sensitivity of the DROM test
Time frame: 3 days
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
12 secondary outcomes
Specificity of the DROM test
Time frame: 3 days
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
Time frame: 3 days
Percentage of agreement between the clinician and the patient before DROM test
Time frame: 3 days
Percentage of agreement between the clinician and the patient after DROM test
Time frame: 3 days
Percentage of patients who completed the DROM test among those who are eligible
Time frame: 1 year
Percentage of test adherence by patients
Time frame: 1 year
Percentage of patients who complete the test.
Time frame: 1 year
Average test duration in minutes
Time frame: 1 year
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)
Time frame: 1 year
Patient's perception evaluation using a 4-question, 5-point Likert scale
Time frame: 1 year
Description of the factors associated with patients not returning home
Time frame: 1 year
Optimal DROM-test threshold to identify patients most likely to demonstrate decisional incapacity
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
Mouna Romdhani, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.