Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients

NCT01723436 | Completed

• 1 other identifier: 816697
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy

Keywords

Decision fatigue

Outcome Measures

Primary Outcomes (1)

• Stroop Test Score

  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 Word trial minus the Color-Word trials. This data will be collected immediately following completion.

  Approximately 15 minutes

Secondary Outcomes (1)

• Evidence of status quo bias

  Approximately 10 minutes

Study Arms (4)

DLST Only

NO INTERVENTION

Surrogates will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)

Contemplate only

EXPERIMENTAL

Surrogates will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question

Other: Hypothetical scenarios and related decisions

Decide with advice

EXPERIMENTAL

Surrogates will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question. Within this arm, surrogates will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention). These positive and negative recommendations will be randomly assigned upon study enrollment. With four hypothetical scenarios, there are six possible options for recommendation variations.

Other: Hypothetical scenarios and related decisions

Decide without advice

EXPERIMENTAL

Surrogates will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.

Other: Hypothetical scenarios and related decisions

Interventions

Hypothetical scenarios and related decisions OTHER

Surrogates 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.

Contemplate only; Decide with advice; Decide without advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 18444745 BACKGROUND

Study Officials

• Scott D. Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Epidemiology, Health Policy and Medical Ethics

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

US (1)