Trial Outcomes & Findings for Intuition vs. Deliberation in Medical Decision Making (NCT NCT02487810)
NCT ID: NCT02487810
Last Updated: 2019-07-19
Results Overview
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.
COMPLETED
NA
200 participants
The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
2019-07-19
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
102
|
|
Overall Study
COMPLETED
|
97
|
102
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Intuition vs. Deliberation in Medical Decision Making
Baseline characteristics by cohort
| Measure |
Intuitive
n=97 Participants
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.
|
Deliberative
n=102 Participants
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
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
67.9 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
67.2 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyPatients 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.
Outcome measures
| Measure |
Intuitive Arm
n=97 Participants
|
Deliberative Arm
n=102 Participants
|
|---|---|---|
|
Acceptance or Refusal of a Feeding Tube for Chronic Aspiration
Accept Feeding Tube
|
41 Participants
|
45 Participants
|
|
Acceptance or Refusal of a Feeding Tube for Chronic Aspiration
Reject Feeding Tube
|
56 Participants
|
57 Participants
|
PRIMARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyPatients 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.
Outcome measures
| Measure |
Intuitive Arm
n=97 Participants
|
Deliberative Arm
n=102 Participants
|
|---|---|---|
|
Acceptance or Refusal of Antibiotics
Accept antibiotics
|
38 Participants
|
44 Participants
|
|
Acceptance or Refusal of Antibiotics
Refuse antibiotics
|
59 Participants
|
58 Participants
|
PRIMARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyPatients 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.
Outcome measures
| Measure |
Intuitive Arm
n=97 Participants
|
Deliberative Arm
n=102 Participants
|
|---|---|---|
|
Acceptance or Refusal of Breathing Machine
Accept intubation
|
57 Participants
|
61 Participants
|
|
Acceptance or Refusal of Breathing Machine
Refuse intubation
|
40 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyPatients 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.
Outcome measures
| Measure |
Intuitive Arm
n=97 Participants
|
Deliberative Arm
n=102 Participants
|
|---|---|---|
|
Acceptance or Refusal of Tracheostomy
Accept tracheostomy
|
36 Participants
|
42 Participants
|
|
Acceptance or Refusal of Tracheostomy
Refuse tracheostomy
|
61 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyDecisional 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.
Outcome measures
| Measure |
Intuitive Arm
n=97 Participants
|
Deliberative Arm
n=102 Participants
|
|---|---|---|
|
Scores on Uncertainty Subscale of Decisional Conflict Scale
Feeding Tube
|
21.5 units on a scale
Standard Deviation 23.1
|
20.9 units on a scale
Standard Deviation 21.1
|
|
Scores on Uncertainty Subscale of Decisional Conflict Scale
Antibiotics
|
20.3 units on a scale
Standard Deviation 21.7
|
18.9 units on a scale
Standard Deviation 21.2
|
|
Scores on Uncertainty Subscale of Decisional Conflict Scale
Intubation
|
26.2 units on a scale
Standard Deviation 25.5
|
20.8 units on a scale
Standard Deviation 22.1
|
|
Scores on Uncertainty Subscale of Decisional Conflict Scale
Tracheostomy
|
29.4 units on a scale
Standard Deviation 25.3
|
23.6 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=26 Participants
|
Deliberative Arm
n=37 Participants
|
|---|---|---|
|
Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death
Accept tracheostomy
|
4 Participants
|
9 Participants
|
|
Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death
Refuse tracheostomy
|
22 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=26 Participants
|
Deliberative Arm
n=37 Participants
|
|---|---|---|
|
Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.
Accept Antibiotics
|
6 Participants
|
13 Participants
|
|
Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.
Refuse Antibiotics
|
20 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=21 Participants
|
Deliberative Arm
n=25 Participants
|
|---|---|---|
|
Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death
Accept Tracheostomy
|
2 Participants
|
8 Participants
|
|
Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death
Refuse Tracheostomy
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=21 Participants
|
Deliberative Arm
n=25 Participants
|
|---|---|---|
|
Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death
Accept Antibiotics
|
4 Participants
|
9 Participants
|
|
Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death
Refuse Antibiotics
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=18 Participants
|
Deliberative Arm
n=26 Participants
|
|---|---|---|
|
Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
Accept Tracheostomy
|
4 Participants
|
5 Participants
|
|
Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
Refuse Tracheostomy
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=18 Participants
|
Deliberative Arm
n=26 Participants
|
|---|---|---|
|
Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
Accept Antibiotics
|
5 Participants
|
8 Participants
|
|
Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
Refuse Antibiotics
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=25 Participants
|
Deliberative Arm
n=32 Participants
|
|---|---|---|
|
Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death
Accept Tracheostomy
|
4 Participants
|
7 Participants
|
|
Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death
Refuse Tracheostomy
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinallyThis 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.
Outcome measures
| Measure |
Intuitive Arm
n=46 Participants
|
Deliberative Arm
n=54 Participants
|
|---|---|---|
|
Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death
Accept feeding tube
|
7 Participants
|
16 Participants
|
|
Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death
Refuse feeding tube
|
39 Participants
|
38 Participants
|
Adverse Events
Intuitive
Deliberative
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Beth Cooney, Assistant Director of FIELDS Program
Fostering Improvement in End-of-Life Decision Science (FIELDS) Program
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place