Clinical trial NCT01723436: Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients
Official title: Pilot Study of Repeated Decision Making in Surrogates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy
Keywords: Decision fatigue
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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. Surrogates are at risk for decision fatigue yet it has not been studied. We propose a randomized study in the outpatient setting in surrogates and patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on surrogate self-control and subsequent choices.

Detailed description: 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. 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 in this population. To elucidate these questions, we propose a four-arm study of surrogates and patients in a population at high risk for making complex decisions. Surrogates 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.

Eligibility criteria: Inclusion Criteria:

* Patients must have one of the following diagnoses: 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.
* Patients must have at least one surrogate at their clinic visit who is willing to enroll with them as a pair to be included.
* Surrogates are eligible if an eligible patient identifies them as as a surrogate and both consent for the study.
* All participants must be over the age 18
* All participants must be fluent in English

Exclusion Criteria:

* Patients and surrogates will be excluded if they are illiterate or have a medical condition known to alter Stroop performance. These include individuals who are visually impaired such that they cannot read a computer screen, blind or colorblind, patients given sedating medications during their appointment and individuals with past medical history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness.
* Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the mechanical ventilation hypothetical scenario and the hypothetical life sustaining therapy question.
* Surrogates and patients are ineligible if their paired participant is excluded for any of the above reasons.

Primary outcomes:
measure: Stroop Test Score
timeFrame: Approximately 15 minutes
Secondary outcomes:
measure: Evidence of status quo bias
timeFrame: Approximately 10 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D. Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vohs KD, Baumeister RF, Schmeichel BJ, Twenge JM, Nelson NM, Tice DM. Making choices impairs subsequent self-control: a limited-resource account of decision making, self-regulation, and active initiative. J Pers Soc Psychol. 2008 May;94(5):883-98. doi: 10.1037/0022-3514.94.5.883.