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| Name | Class |
|---|---|
| Leonard Davis Institute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intuitive | Experimental | 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. |
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| Deliberative | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive load | Behavioral | Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptance or Refusal of a Feeding Tube for Chronic Aspiration | 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. | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
| Acceptance or Refusal of Antibiotics | 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. | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
| Acceptance or Refusal of Breathing Machine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on Uncertainty Subscale of Decisional Conflict Scale | Decisional uncertainty will be evaluated using the uncertainty subscale of the Decisional Conflict Scale ranging from 0-100 such that 0 = extremely CERTAIN about best choice and 100 = extremely UNCERTAIN about the best choice. Higher values represent MORE UNCERTAINTY with decisions regarding feeding tubes, antibiotics, intubation, and tracheostomy while lower values represent LESS UNCERTAINTY. |
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Inclusion Criteria:
Age 60 and older
Currently an inpatient at Hospital of the University of Pennsylvania
Speaks and reads fluently in English
Either
Has one of the following medical conditions:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Halpern, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30681717 | Derived | Rubin EB, Buehler AE, Cooney E, Gabler NB, Mante AA, Halpern SD. Intuitive vs Deliberative Approaches to Making Decisions About Life Support: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187851. doi: 10.1001/jamanetworkopen.2018.7851. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions. |
| FG001 | 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. Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptance or Refusal of a Feeding Tube for Chronic Aspiration | 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. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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This is a minimal risk study. We did not monitor for serious adverse events because 0 participants were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Cooney, Assistant Director of FIELDS Program | Fostering Improvement in End-of-Life Decision Science (FIELDS) Program | 215-573-9461 | elcooney@exchange.upenn.edu |
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| Deliberative instructions | Behavioral | Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions |
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| The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
| Acceptance or Refusal of Tracheostomy | 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. | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
| 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 Being Bed Bound is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept tracheostomy AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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. | This outcome measures the proportion of participants who accept antibiotics AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept tracheostomy AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept antibiotics AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept tracheostomy AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept antibiotics AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept tracheostomy AND indicate that relying on a breathing machine is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | 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 | This outcome measures the proportion of participants who accept a feeding tube AND indicate that relying on a feeding tube is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
| BG001 | 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. Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Deliberative Arm |
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| Primary | Acceptance or Refusal of Antibiotics | 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. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Primary | Acceptance or Refusal of Breathing Machine | 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. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Primary | Acceptance or Refusal of Tracheostomy | 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. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Scores on Uncertainty Subscale of Decisional Conflict Scale | Decisional uncertainty will be evaluated using the uncertainty subscale of the Decisional Conflict Scale ranging from 0-100 such that 0 = extremely CERTAIN about best choice and 100 = extremely UNCERTAIN about the best choice. Higher values represent MORE UNCERTAINTY with decisions regarding feeding tubes, antibiotics, intubation, and tracheostomy while lower values represent LESS UNCERTAINTY. | Posted | Mean | Standard Deviation | units on a scale | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept tracheostomy AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death. | This outcome measures the proportion of participants who accept antibiotics AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept tracheostomy AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept antibiotics AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept tracheostomy AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept antibiotics AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept tracheostomy AND indicate that relying on a breathing machine is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| Secondary | Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death | This outcome measures the proportion of participants who accept a feeding tube AND indicate that relying on a feeding tube is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared. | Posted | Count of Participants | Participants | The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally |
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| 0 |
| 0 |
| 0 |
| 97 |
| EG001 | 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. Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions | 0 | 0 | 0 | 102 |
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| Intubation |
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| Tracheostomy |
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