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Patient Understanding of End of Life Care

This study has been completed.
Information provided by (Responsible Party):
Partners in Internal Medicine Identifier:
First received: July 25, 2012
Last updated: September 7, 2012
Last verified: September 2012
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 Intervention
Advance Directives Resuscitation Orders Other: Standardized explanation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion

Resource links provided by NLM:

Further study details as provided by Partners in Internal Medicine:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 300
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  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 identifier: 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
  More Information

Responsible Party: Partners in Internal Medicine Identifier: NCT01683097     History of Changes
Other Study ID Numbers: SVH 1195
Study First Received: July 25, 2012
Last Updated: September 7, 2012 processed this record on August 16, 2017