Patient-Centered Advance Care Planning

Heart Failure Clinical Trial

Official title:

A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204802
• Other study ID #: 2003-165
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 1, 2015
• Start date: January 2004
• Est. completion date: July 2008

Study information

• Verified date: March 2009
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: July 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At high risk for impending death in the next 12 months

Exclusion Criteria:

• Patient not having decision-making capacity

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Heart Failure
• Renal Failure

Intervention

Behavioral:
• Patient-Centered Advance Care Planning

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of PC-ACP