DROM Test, a Clinical Decision Support Tool for Assessing the Ability to Decide on Returning Home in Elderly Patients with Cognitive Impairments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Sensitivity of the DROM test
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
Person aged 70 and over with a neurocognitive disorder and hospitalized in geriatrics
干预措施: DROM-Test (Other)
结局指标
主要结局
Sensitivity of the DROM test
时间窗: 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
次要结局
- Specificity of the DROM test(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(3 days)
- Percentage of agreement between the clinician and the patient before DROM test(3 days)
- Percentage of agreement between the clinician and the patient after DROM test(3 days)
- Percentage of patients who completed the DROM test among those who are eligible(1 year)
- Percentage of test adherence by patients(1 year)
- Percentage of patients who complete the test.(1 year)
- Average test duration in minutes(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)(1 year)
- Patient's perception evaluation using a 4-question, 5-point Likert scale(1 year)
- Description of the factors associated with patients not returning home(1 year)
- Optimal DROM-test threshold to identify patients most likely to demonstrate decisional incapacity(1 year)