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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01233973
Other study ID # 2010-P-000180
Secondary ID
Status Completed
Phase N/A
First received November 1, 2010
Last updated April 28, 2012
Start date July 2010
Est. completion date February 2011

Study information

Verified date April 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.


Description:

A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill.

Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities.

A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- over age of 64

- have decision making capacity

Exclusion Criteria:

- do not speak English

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
video decision aid
video

Locations

Country Name City State
United States MGH Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary preference for medical care preference for care at the end of life 5 minutes after the survey No
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