Intuition Versus Deliberation in Decisions About Life-Sustaining Medical Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Acceptance or Refusal of Breathing Machine
研究概览
简要总结
The purpose of this study is to determine whether there are systematic differences between the decisions patients make intuitively versus deliberatively about life-sustaining medical therapies.
The targeted population is inpatients at the Hospital of the University of Pennsylvania with serious medical problems. The study will involve facilitated interviews with patients using a survey instrument developed in Qualtrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 and older
- •Currently an inpatient at Hospital of the University of Pennsylvania
- •Speaks and reads fluently in English
- •Has one of the following medical conditions:
- •Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry and/or eligible for long-term oxygen therapy
- •Incurable interstitial lung disease with at least severe restriction on most recent pulmonary function tests and/or eligible for long-term oxygen therapy
- •Congestive heart failure with NYHA Class III or higher and current hospitalization related to heart failure
- •Acute myeloid leukemia
- •Stage IV lymphoma
- •Stage IIIB or Stage IV non-small cell lung cancer, cholangiocarcinoma, renal cell carcinoma, breast cancer, uterine cancer, cervical cancer, ovarian cancer, colorectal cancer, gastric cancer, pancreatic cancer, prostate cancer, urothelial cancer
- •Stage C or D hepatocellular carcinoma
- •Mesothelioma or any malignancy metastatic to the pleura; or
- •Is hospitalized on oncology, pulmonary or cardiology service and has been hospitalized at least one other time during the last year on the same service
- •Stable vital signs
排除标准
- •Notation of code status limitation in electronic medical record
- •Cognitive impairment to the point unable to give informed consent
- •Current feeding tube placement
- •Current tracheostomy
- •Severe pain, shortness of breath or other uncontrolled symptoms
- •Actively undergoing evaluation for solid organ transplant
- •First hospitalization after diagnosis of serious illness
研究组 & 干预措施
Deliberative
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.
干预措施: Deliberative instructions (Behavioral)
Intuitive
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.
干预措施: Cognitive load (Behavioral)
结局指标
主要结局
Acceptance or Refusal of Breathing Machine
时间窗: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a breathing machine. In this hypothetical scenario, patients are presented with a life-threatening illness with 50% chance of survival provided that they receive support from a breathing machine for two weeks. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of Tracheostomy
时间窗: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a tracheostomy and support from a breathing machine for at least two months to survive. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of a Feeding Tube for Chronic Aspiration
时间窗: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a feeding tube for chronic aspiration. In this hypothetical scenario, patients are presented with a situation in which they are unable to eat or drink safely such that small amounts of food or liquid go to their lungs and cause trouble with breathing. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of Antibiotics
时间窗: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of antibiotics. In this hypothetical scenario, patients are presented with an illness severity such that they drift in and out of consciousness some days and are expected to die in several months. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
次要结局
- Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Scores on Uncertainty Subscale of Decisional Conflict Scale(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
- Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death(The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally)
研究者
Scott Halpern
Assistant Professor of Medicine
University of Pennsylvania