An interventional study of Cognitive load and Deliberative instructions in Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Either
Has one of the following medical conditions:
Exclusion Criteria:
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.
Behavioral: Cognitive load
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.
Behavioral: Deliberative instructions
Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
| Milestone | Intuitive | Deliberative |
|---|---|---|
| Started | 98 | 102 |
| Completed | 97 | 102 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Feeding Tube | 41 | 45 |
| Reject Feeding Tube | 56 | 57 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept antibiotics | 38 | 44 |
| Refuse antibiotics | 59 | 58 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept intubation | 57 | 61 |
| Refuse intubation | 40 | 41 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept tracheostomy | 36 | 42 |
| Refuse tracheostomy | 61 | 60 |
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.
| units on a scale | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Feeding Tube | 21.5 ± 23.1 | 20.9 ± 21.1 |
| Antibiotics | 20.3 ± 21.7 | 18.9 ± 21.2 |
| Intubation | 26.2 ± 25.5 | 20.8 ± 22.1 |
| Tracheostomy | 29.4 ± 25.3 | 23.6 ± 24.8 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept tracheostomy | 4 | 9 |
| Refuse tracheostomy | 22 | 28 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Antibiotics | 6 | 13 |
| Refuse Antibiotics | 20 | 24 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Tracheostomy | 2 | 8 |
| Refuse Tracheostomy | 19 | 17 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Antibiotics | 4 | 9 |
| Refuse Antibiotics | 17 | 16 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Tracheostomy | 4 | 5 |
| Refuse Tracheostomy | 14 | 21 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Antibiotics | 5 | 8 |
| Refuse Antibiotics | 13 | 18 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept Tracheostomy | 4 | 7 |
| Refuse Tracheostomy | 21 | 25 |
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.
| Participants | Intuitive Arm | Deliberative Arm |
|---|---|---|
| Accept feeding tube | 7 | 16 |
| Refuse feeding tube | 39 | 38 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intuitive | — | — | 0/97 (0%) |
| Deliberative | — | — | 0/102 (0%) |
| Age, Continuous(years) | Intuitive | Deliberative | Total |
|---|---|---|---|
| Mean | 66.5 ± 4.8 | 67.9 ± 5.2 | 67.2 ± 5.0 |
| Sex: Female, Male(Participants) | Intuitive | Deliberative | Total |
|---|---|---|---|
| Female | 33 | 34 | 67 |
| Male | 64 | 68 | 132 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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