Advance Care Planning: A Way to Improve End-of-life Care Life Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Aarhus
Sponsor:
Collaborators:
TrygFonden, Denmark
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01944813
First received: September 6, 2013
Last updated: December 18, 2013
Last verified: September 2013
  Purpose

Communication about end-of-life issues is often suboptimal. A way to improve the quality of end-of-life care is Advance Care Planning (ACP). ACP is a discussion between an incurable ill patient and the health professionals about preferences for end-of-life care. In Denmark, there is no tradition of systematic communication with patients about end-of-life care. The aim is to investigate how ACP can be beneficial among incurable ill patients treated in an outpatient context and if the concept is feasible in a Danish context. The study is designed as a prospective randomised controlled trial. Patients from relevant departments will be included and randomised in two groups: one receiving usual care and the other receiving usual care and ACP. Data will be collected from Electronic Patient Files and from questionnaires. If ACP is effective, it will improve the quality of end-of-life care for patients and their families and reduce the psychological distress in the bereaved relatives.


Condition Intervention
Heart Failure
Pulmonary Disease
Neoplasms
Behavioral: ACp conversation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Advance Care Planning: A Way to Improve End-of-life Care

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The proportion of patients who had their preferences regarding place of care and place of death met [ Time Frame: 1.7.2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of re-admissions to hospital from time of inclusion until death [ Time Frame: 1.7.2015 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The proportion of bereaved relatives who experienced symptoms of stress, anxiety and depression after the death of the patient, measured three months after the death of the patient [ Time Frame: 1.7.2015 ] [ Designated as safety issue: No ]
  • The proportion of patients who died at home [ Time Frame: 1.7.2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: November 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention: ACP conversation
Intervention: Advance Care Planning conersation between a healtprofessionel and a patient about end-of-life discussions.
Behavioral: ACp conversation
Intervention: Advance Care Planning conersation between a healtprofessionel and a patient about end-of-life discussions.
No Intervention: No intervention: usual care
No intervention just usual care

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Eligible patients from the departments of oncology, cardiology and respiratory medicine at Aarhus University Hospital
  • the patient is over 18
  • acceptable Danish language skills

Exclusion Criteria:

  • cognitive impairment
  • expected to dy within the next month
  • has no relatives
  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 ClinicalTrials.gov identifier: NCT01944813

Contacts
Contact: Mrs. Marianne H Skorstengaard, MD 28456763 ext 78462598 mhsk@ki.au.dk
Contact: Mr. Anders B Jensen, Professor andjense@rm.dk

Locations
Denmark
Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Mrs. Marianne H Skorstengaard, MD    28456763 ext 78462598    mhsk@ki.au.dk   
Sub-Investigator: Marianne H Skorstengaard, MD         
Sponsors and Collaborators
University of Aarhus
TrygFonden, Denmark
Danish Cancer Society
Investigators
Principal Investigator: Anders B Jensen, Professor Department of oncology Aarhus University
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01944813     History of Changes
Other Study ID Numbers: 050880
Study First Received: September 6, 2013
Last Updated: December 18, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Advance Care planning
End-of-life Discussions
Questionaires
Palliative Care

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014