N/A N=200 Randomized Single-blind Other

Intuition vs. Deliberation in Medical Decision Making

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

Bottom Line

View on ClinicalTrials.gov: NCT02487810 ↗

Enrolled (actual)

200

Serious AEs

—

Results posted

Jul 2019

Primary outcome: Primary: Acceptance or Refusal of a Feeding Tube for Chronic Aspiration — 41; 45; 56; 57 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive load (Behavioral); Deliberative instructions (Behavioral)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Acceptance or Refusal of a Feeding Tube for Chronic Aspiration	41; 45; 56; 57	—
PRIMARY Acceptance or Refusal of Antibiotics	38; 44; 59; 58	—
PRIMARY Acceptance or Refusal of Breathing Machine	57; 61; 40; 41	—
PRIMARY Acceptance or Refusal of Tracheostomy	36; 42; 61; 60	—
SECONDARY Scores on Uncertainty Subscale of Decisional Conflict Scale	21.5; 20.9; 20.3; 18.9; 26.2; 20.8	—
SECONDARY Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death	4; 9; 22; 28	—
SECONDARY Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.	6; 13; 20; 24	—
SECONDARY Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death	2; 8; 19; 17	—
SECONDARY Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death	4; 9; 17; 16	—
SECONDARY Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death	4; 5; 14; 21	—
SECONDARY Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death	5; 8; 13; 18	—
SECONDARY Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death	4; 7; 21; 25	—
SECONDARY Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death	7; 16; 39; 38	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02487810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.