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Advance care planning (ACP) in COPD.


- candidate number14688
- NTR NumberNTR3940
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2013
- Secondary IDsNL42437.060.12 METC CZE
- Public TitleAdvance care planning (ACP) in COPD.
- Scientific TitleA randomized controlled trial on the influence of structured advance care planning (ACP) on quality of end-of-life care communication and quality of end-of-life care in patients with COPD.
- ACRONYM
- hypothesis1.1 Structured ACP for patients with COPD will improve quality of communication about end-of-life care.
1.2 Structured ACP for patients with COPD will not increase symptoms of anxiety and depression of patients and family members at six months after ACP.
1.3 Structured ACP for patients with COPD will improve quality of end-of-life care and quality of dying.

2.1 Structured ACP will improve concordance between patient's preferences for end-of-life care and the end-of-life care received.
2.2 Structured ACP will reduce psychological distress in bereaved family members of deceased patients with COPD.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Palliative care
- Inclusion criteria1. A diagnosis of severe to very severe COPD (GOLD stage III or IV) according to GOLD guidelines;
2. Discharged after hospital admission for an acute COPD exacerbation;
3. At least one loved one, who will participate in the study.
- Exclusion criteria1. Unable to complete the study questionnaires because of cognitive impairment;
2. Unable to speak or understand Dutch.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate1-okt-2016
- Target number of participants300
- InterventionsIntervention group:
Patients and family members in the intervention group will receive a structured advance care planning session by a trained respiratory nurse specialist in their home environment within 4 weeks after discharge.

Control group:
Patients in the control group will receive usual care.
- Primary outcome1. Quality of communication about end-of-life care;
2. Symptoms of anxiety and depression;
3. Quality of end-of-life care;
4. Quality of dying.
- Secondary outcome1. Patient's preferences for end-of-life care;
2. Received end-of-life care;
3. Psychological distress in bereaved family members of deceased patients with COPD.
- TimepointsInterviews and questionnaires will be assessed during home visits at baseline and after 6 months in patients in the intervention and usual care group.
At baseline and after 6 months telephone interviews with the participating family members in the intervention and usual care group will take place.
Patients and family members in the intervention group will receive a structured advance care planning session <4 weeks after discharge. Finally, patients in the intervention and usual care group will receive a phone call 12 months after enrolment. If patients deceased during the study period, a bereavement interview will be conducted with the participating family member.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. D.J.A. Janssen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. D.J.A. Janssen
- Sponsor/Initiator CIRO+ (Centre of expertise for chronic organ failure)
- Funding
(Source(s) of Monetary or Material Support)
Lung Foundation Netherlands
- PublicationsN/A
- Brief summaryBackground:
Advance care planning (ACP) is the process of communication between patients, family and professional caregivers that includes, but is not limited to, the completion off advance directives. ACP can change outcomes for patients and relatives. ACP may be particularly important for patients with Chronic Obstructive Pulmonary Disease (COPD). Data from patients, their family and physicians suggest that ACP is uncommon and poorly done. In a recent project we found that patients with advanced COPD are able to indicate their preferences for life-sustaining treatments. However, in only 6% of the patients, the patient and chest physician report having discussed these preferences. Patients rated their cliniciansí skills at discussing end-of-life topics as poor.
We hypothesize that structured ACP by a trained nurse, in collaboration with the patientís physician, can improve quality of communication about end-of-life care, will not increase symptoms of anxiety and depression, and can improve quality of end-of-life care and quality of dying for patients with COPD as well as outcomes for bereaved family members of deceased patients with COPD.

Objectives:
Primary objectives of this study are to assess whether and to what extent structured ACP for patients with COPD can improve quality of communication about end-of life care; to study whether and to what extent structured ACP for patients with COPD may influence symptoms of anxiety and depression of patients and family members at six months after ACP; and to study whether and to what extent structured ACP for patients with COPD can improve quality of end-of-life care and quality of dying. Secondary objectives are to investigate whether structured ACP can improve concordance between patientís preferences for end-of-life care and the end-of-life care received; and to investigate whether structured ACP can reduce psychological distress in bereaved family members of deceased patients with COPD.

Study design:
This study is a prospective randomized controlled trial.

Study population:
The study population will consist of 300 patients with severe to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III or IV) discharged after hospital admission for an exacerbation of COPD and 1-3 family members per patient.

Intervention:
Patients and family members in the intervention group will receive a structured ACP session by a trained respiratory nurse specialist in their home environment within 4 weeks after discharge. Patients in the control group will receive usual care.

Primary study parameters:
The intervention and usual care group will be compared on changes in quality of communication; and symptoms of anxiety and depression. In patients who died, quality of death and dying; quality of end-of-life care; end-of-life care preferences and received end-of-life care will be compared between the intervention and the control group.
- Main changes (audit trail)
- RECORD8-apr-2013 - 23-jun-2013


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