NCT01683097

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

July 25, 2012

Last Update Submit

September 7, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

Questionnaire

Intervention

EXPERIMENTAL

Standardized explanation followed by questionnaire

Other: Standardized explanation

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Admitted to regular nursing floor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

Study Officials

  • George Abraham, MD

    Saint Vincent Hospital

    PRINCIPAL INVESTIGATOR
  • Kriti Mittal, MD

    Saint Vincent Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

September 11, 2012

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations