Effects of Frequent Decision Making Among Patients With Serious Illnesses
11 augustus 2017 bijgewerkt door: Scott Halpern, University of Pennsylvania
Pilot Study of Repeated Decision Making in Patients
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
66
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Perelman Center for Advanced Medicine at the University of Pennsylvania
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: DLST Only
Patients will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)
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Experimenteel: Contemplate only
Patients will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question
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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.
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Experimenteel: Decide with advice
Patients will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question.
Within this arm, patients 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.
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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.
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Experimenteel: Decide without advice
Patients will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stroop test score
Tijdsspanne: Approximately 15 minutes
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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.
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Approximately 15 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Evidence of status quo bias
Tijdsspanne: Approximately 10 minutes
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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.
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Approximately 10 minutes
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Scott D. Halpern, MD, PhD, University of Pennsylvania
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2012
Primaire voltooiing (Werkelijk)
1 mei 2013
Studie voltooiing (Werkelijk)
1 mei 2013
Studieregistratiedata
Eerst ingediend
31 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
2 november 2012
Eerst geplaatst (Schatting)
6 november 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- UPenn -816696
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .