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Patient Understanding of End of Life Care

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ClinicalTrials.gov Identifier: NCT01683097
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):
Partners in Internal Medicine

Brief Summary:
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire

Condition or disease Intervention/treatment
Advance Directives Resuscitation Orders Other: Standardized explanation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion
Study Start Date : March 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention
Standardized explanation followed by questionnaire
Other: Standardized explanation
Standardized explanation provided on code status, advance directives and end of life care

Primary Outcome Measures :
  1. Composite score of correct responses [ Time Frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview ]
    Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire

Secondary Outcome Measures :
  1. Compare differences in demographic, medical, social and associated factors on patient choice of code status [ Time Frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18 years
  • Admitted to regular nursing floor

Exclusion Criteria:

  • altered mental status
  • admitted in ICU
  • positive screening for depression
  • terminal illness defined as life expectancy< 100 days
  • inability to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683097

United States, Massachusetts
Saint Vincent Hospital
Worcester, Massachusetts, United States, 01608
Sponsors and Collaborators
Partners in Internal Medicine
Principal Investigator: George Abraham, MD Saint Vincent Hospital
Principal Investigator: Kriti Mittal, MD Saint Vincent Hospital

Responsible Party: Partners in Internal Medicine
ClinicalTrials.gov Identifier: NCT01683097     History of Changes
Other Study ID Numbers: SVH 1195
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012