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Completed

NCT Number: NCT02487810

Intuition vs. Deliberation in Medical Decision Making

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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Key information

Conditions

Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Deliberative instructions

Behavioral

Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions

Primary outcomes

  1. Acceptance or Refusal of a Feeding Tube for Chronic Aspiration

    Time frame: 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.

  2. Acceptance or Refusal of Antibiotics

    Time frame: 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.

  3. Acceptance or Refusal of Breathing Machine

    Time frame: 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.

  4. Acceptance or Refusal of Tracheostomy

    Time frame: 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.

Secondary outcomes

  1. Scores on Uncertainty Subscale of Decisional Conflict Scale

    Time frame: 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.

  2. Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death

    Time frame: 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.

  3. Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.

    Time frame: 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.

  4. Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death

    Time frame: 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.

  5. Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death

    Time frame: 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.

  6. Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death

    Time frame: 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.

  7. Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death

    Time frame: 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.

  8. Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death

    Time frame: 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.

  9. Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Leonard Davis Institute

Registry information

Official study title

Intuition Versus Deliberation in Decisions About Life-Sustaining Medical Therapies

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2015
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.