A ProspectiveTrial Using Video Images in Advance Care Planning in Hospitalized Seriously Ill Patients With Advanced Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01527331
First received: January 26, 2012
Last updated: April 28, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to compare the decision making of hospitalized subjects with advanced cancer having a verbal discussion about CPR compared to subjects using a video.


Condition Intervention
Advanced Cancer
Behavioral: video decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • preferences for medical care regarding CPR (yes, no or unsure) [ Time Frame: within 5 minutes of surveyor asking the questions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knowledge of CPR [ Time Frame: 5 minutes after the surveyor asks questions ] [ Designated as safety issue: No ]
    Knowledge of CPR will be ascertained using True/False questions and one multiple choice question. Answers will be tallied into a score. Subjects will answer questions before the intervention (Baseline) as well as immediately after the intervention (within approximately 15 minutes of the intervention).

  • code status on subsequent admissions (Full code, DNR/DNI, etc.) [ Time Frame: subsequent hospital admissions within one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
usual care
Experimental: Video decision aid arm Behavioral: video decision aid
cpr video decision aid

Detailed Description:

Aim 1: To recruit 150 subjects with advanced cancer admitted to the inpatient oncology ward with an overall prognosis of one year or less and randomly assign these subjects to:

  1. a video visually depicting CPR preferences or
  2. the current standard of care without the use of video (control).

Hypothesis 1: It is feasible to recruit and randomize 150 hospitalized subjects with advanced cancer and an overall prognosis of one year or less.

Aim 2: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.

Aim 3: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.

Hypothesis 3: Subjects randomized to the video are more likely to have their code status documented in the electronic medical records compared to those who do not see the video.

Aim 4: To compare the decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 4: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.

Aim 5: To compare knowledge assessment of CPR of subjects randomized to video and subjects randomized to current standard of care without the video.

Hypothesis 5: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

Aim 6: To compare code-status (CPR, and intubation) preferences in the electronic medical record on future hospitalizations up to one year post-hospital discharge of subjects randomized to video and subjects randomized to current standard of care without the video.

Hypothesis 6: Subjects randomized to the video are more likely to opt against CPR and intubation in the future compared to those who do not see the video.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential subjects will be identified by the research assistant. The specific eligibility criteria include:

    1. Over the age of 60
    2. The ability to provide informed consent
    3. The ability to communicate in English
    4. An established diagnosis of metastatic cancer with a prognosis of one year or less confirmed with the attending physician on service.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527331

Contacts
Contact: Angelo Volandes, MD 6176434266 avolandes@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Angelo Volandes, MD    617-643-4266    avolandes@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Stanford University
  More Information

No publications provided

Responsible Party: Angelo E. Volandes, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01527331     History of Changes
Other Study ID Numbers: 2011P000010
Study First Received: January 26, 2012
Last Updated: April 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014