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A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit

NCT ID: NCT01589107

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Detailed Description

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Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.

Conditions

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Surgery Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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control group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Video Arm

Group Type EXPERIMENTAL

video decision aid

Intervention Type BEHAVIORAL

video decision aid

Interventions

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video decision aid

video decision aid

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical surrogates of the following patients will be eligible to participate in this opinion survey:

1. All patients admitted to the SICU and not expected to die within 48 hours.
2. Patient has been admitted to the acute care surgical service,
3. The patient is over the age of 50 and does not have decision making capacity.
* Subjects must be over the age of 21 and English speaking to participate in the opinion survey.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Angelo E. Volandes, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelo Volandes

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Angelo Volandes

Role: primary

Other Identifiers

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2011-P-001731

Identifier Type: -

Identifier Source: org_study_id