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Identification of Patients with COPD with a Poor Prognosis and Implementation of Proactive Palliative Care


- candidate number15011
- NTR NumberNTR4037
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2013
- Secondary IDs2012/260 CMO registration number
- Public TitleIdentification of Patients with COPD with a Poor Prognosis and Implementation of Proactive Palliative Care
- Scientific TitleIdentification of Patients with COPD with a Poor Prognosis and Implementation of Proactive Palliative Care
- ACRONYMPROLONG
- hypothesisThe study consists of an indicator study and an intervention study.
1. Indicator study
We expect that the set of indicators will have discriminative power to predict readmission within 8 weeks and/or death within 1 year for patients hospitalized for AECOPD .
2. Intervention study
We expect that proactive palliative care for patients with COPD will: increase the quality of life of these patients, decrease the level of overburdening of their caretakers, decrease the number and length of acute hospital admissions, prolong survival, and decrease the amount of patients that die in the ICU.
- Healt Condition(s) or Problem(s) studiedCOPD, Palliative care , Quality of life, Prognosis
- Inclusion criteria- All patients with an acute exacerbation COPD (AECOPD) admitted to the hospital, and
- Aged 18 years or older.
- Exclusion criteria- Not speaking the dutch language, or
- Severe cognitive disorders, or
- At moment of inclusion in treatment with a specialized palliative care team.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-dec-2013
- planned closingdate1-jul-2015
- Target number of participants174
- InterventionsThe investigational product is a behavioral intervention. In the intervention hospitals, members of the specialized palliative care teams will receive training in implementation of palliative care for patients with COPD. The training will be given by palliative care professionals of the UMC St. Radboud in Nijmegen and will take place in the three month before start of the controlled trial. It consists of two consecutive meetings of each three hours. The following topics will be discussed:
Discussion of end of life aspects with patient and family;
Creating a patient-tailored supportive care plan;
Learning to anticipate on illness- and dying scenarios;
Transfer of care to lung specialist and general practitioner (GP);
Performing the supportive care plan in cooperation with the lung specialist. During the controlled trial patients in the intervention hospitals who are assigned for palliative care will meet with a member of the palliative care team within 1 week after enrolment and at least monthly thereafter in the outpatients setting until the end of the trial or death. The main caregiver of the patient will be asked to be present at those meetings. Guidelines for the palliative care meetings in the ambulatory setting are adapted from the general guidelines palliative care in the Netherlands.
- Primary outcomeThe primary outcome measure of the indicator study is:
- Length of time from the moment that a patient hospitalized for AECOPD meets two or more criteria of the set of indicators until death for any cause.
The primary outcome measure of the intervention study is:
- Quality of life of the patient (SGRQ)
- Secondary outcomeThe secondary outcome measures of the indicatorstudy are:
1. Length of time from the moment that a patient hospitalized for AECOPD meets two or more criteria of the set of indicators until first unexpected admission to hospital.
2. The sensitivity and specificity of the set of indicators, that indicate the start of supportive care for patients hospitalized for COPD, in predicting death for any cause within 1 year.
3. The sensitivity and specificity of the set of indicators, that indicate the start of supportive care for patients with COPD, in predicting the first unexpected admission to hospital within 8 weeks.
4. Length of time from the moment that a patient hospitalized for AECOPD meets two or more criteria of the set of indicators until death as a result of pulmonary insufficiency.
5. Length of time from the moment that a patient hospitalized for AECOPD meets two or more criteria of the set of indicators until first unexpected admission to hospital as a result of pulmonary insufficiency.
6. The sensitivity and specificity of the set of indicators, that indicate the start of supportive care for patients hospitalized for COPD, in predicting death as a result of pulmonary insufficiency within 1 year.
7. The sensitivity and specificity of the set of indicators, that indicate the start of supportive care for patients with COPD, in predicting the first unexpected admission to hospital as a result of pulmonary insufficiency within 8 weeks.
8. What is the contribution of individual indicators (or clusters), in predicting death for any cause within 1 year?
9. What is the contribution of individual indicators (or clusters), in predicting the first unexpected admission to hospital within 8 weeks?
10. What is the contribution of individual indicators (or clusters), in predicting death as a result of pulmonary insufficiency within 1 year?
11. What is the contribution of individual indicators (or clusters), in predicting the first unexpected admission to hospital as a result of pulmonary insufficiency within 8 weeks?

The secondary outcome measures of the intervention study are:
For the patient
1. Quality of life at the end of life (McGill QOL)
2. Psychological wellbeing (HADS)
3. Illness understanding
4. Number and length of unexpected hospital admissions
5. Number and length of unexpected ICU admissions
6. Are the choices of Advance Care Planning (ACP) imported into the medical file? (when yes / when no)
7. Place of death (ICU / hospital / hospice / at home)
8. Is preferred place of death known? (when yes / when no)
9. Has this wish come true? (when yes / when no)
10. Length of survival in COPD patients with supportive care integrated with standard care versus standard care only

For the caregiver
1. Caregiver burden (EDIZ)
2. Psychological wellbeing (HADS)
3. Illness understanding
- TimepointsThe patients and their main caregiver will be followed at baseline (during hospital admission), and thereafter every 3 month until the end of the trial at 18 months by administering questionnaires (for patients: SGRQ, McGill, HADS and illness understanding; for main caregivers: EDIZ, HADS and illness understanding). In addition, retrospectively the researchers extract data from the medical records of the patients at the end of the trial over the complete trial period. They will look for date, number and length of unexpected hospital admissions, date, number and length of unexpected ICU admissions, the choices of Advance Care Planning (ACP), place of death and length of survival.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Yvonne Engels
- CONTACT for SCIENTIFIC QUERIESDr. Yvonne Engels
- Sponsor/Initiator Radboud University Medical Centre Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryProactive palliative care is not very common for patients with Chronic Obstructive Pulmonary Disease (COPD). Important barriers in the provision of proactive palliative care for patients with COPD are: the identification of patients who can benefit from proactive care and the organization of proactive palliative care. Based on recent literature a set of indicators is developed to identify patients hospitalized for acute exacerbation COPD (AECOPD) who are at risk for post-discharge mortality. Once identified a multi disciplinary approach to palliative care with access to a specialized palliative care team will be offered. The study is divided into an indicator study and an intervention study. We expect the set of indicators to be indicative of predicting readmission within 8 weeks and/or death within 1 year for patients hospitalized for AECOPD. We also expect that proactive palliative care for patients with COPD will: increase the quality of life of these patients, decrease the level of overburdening of their caregivers, decrease the number and length of acute hospital admissions and ICU admissions, prolong survival, and decrease the amount of patients that die in the ICU.
- Main changes (audit trail)
- RECORD18-jun-2013 - 29-jun-2013


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