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Patient Understanding of End of Life Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Partners in Internal Medicine
ClinicalTrials.gov Identifier:
NCT01683097
First received: July 25, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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
Questionnaire
Experimental: Intervention
Standardized explanation followed by questionnaire
 Other: Standardized explanation
Standardized explanation provided on code status, advance directives and end of life care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683097

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

No publications provided

Responsible Party: Partners in Internal Medicine
ClinicalTrials.gov Identifier: NCT01683097     History of Changes
Other Study ID Numbers: SVH 1195
Study First Received: July 25, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013