Skip to main content
OpenTrials
Completed

NCT Number: NCT01722123

Effects of Frequent Decision Making Among Patients With Serious Illnesses

Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The result is decision fatigue, in which subsequent decisions are altered toward the status quo. Patients are at risk for decision fatigue yet it has not been studied. The Investigator proposes a randomized study in the outpatient setting in patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on participant self-control and subsequent choices.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made. This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue. (1) People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo. By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities. Patients and their surrogates often make complex medical decisions for which they may have little experience. Although clearly at high risk, decision fatigue has not been studied this population. To elucidate these questions, we propose a four arm study of patients in a population at high risk for making complex decisions. Participants will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma
  • All participants must be over the age 18
  • All participants must be fluent in English

Exclusion criteria

  • Any medical condition known to alter Stroop performance; i.e. significant visual impairment, blind or colorblind, sedating medications during appointment, history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness
  • Patients will also be ineligible if they are illiterate
  • Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the hypothetical medical scenarios/decisions

Treatment and study plan

Hypothetical scenarios and related decisions

Other

Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making. We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.

Primary outcomes

  1. Stroop test score

    Time frame: Approximately 15 minutes

    Measurement of score will be done at the conclusion of instrument completion. The Stroop test is a standard measure of self control that requires three tasks. The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in. Standard scoring is the number correct in the W trial minus the CW trials. This data will be collected immediately following completion.

Secondary outcomes

  1. Evidence of status quo bias

    Time frame: Approximately 10 minutes

    Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment. To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST). In the question, continuing life sustaining therapy will be counted as maintaining the status quo. This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Pilot Study of Repeated Decision Making in Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 6, 2012
Registry last updated
Aug 15, 2017

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.

Published trials that share one or more normalized conditions with this study.