Patient Understanding of End of Life Care

Advance Directives Clinical Trial

Official title:

Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683097
• Other study ID #: SVH 1195
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: September 7, 2012
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: Partners in Internal Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advance Directives
• Resuscitation Orders

Intervention

Other:
• Standardized explanation
Standardized explanation provided on code status, advance directives and end of life care

Locations

Country	Name	City	State
United States	Saint Vincent Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Partners in Internal Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite score of correct responses	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	Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview	No
Secondary	Compare differences in demographic, medical, social and associated factors on patient choice of code status		Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview	No