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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

Results posted on

2019-07-19

Participant Flow

Participant milestones

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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 longitudinally

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Deliberative

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 215-573-9461

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place