NCT00594971

Brief Summary

Background: Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and international research shows that the majority of terminally ill cancer patients wish to die at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has traditionally had the full responsibility for the palliative care of terminally ill cancer patients. In recent years changes have been made to the organisation of palliative care: some hospitals have set up specialised palliative care teams and in some areas of Denmark hospices have been established. Recent research defines a problem when it comes to communication between the hospital and general practice when the patient is being discharged. This is often done in a way that can cause the patient to feel "left in limbo", especially if it is not completely clear to the patient and his or her relatives who has the responsibility for the palliative care. Objective:

  1. 1.To describe consequences for patients, relatives and health care professionals of three different ways of organising palliative care
  2. 2.To collect data which describes patients who are candidates to a shared care approach between general practice and a specialised palliative care team
  3. 3.To collect data which describes the palliative phase (place of death and palliative care, admissions to hospital, involvement of GP and district nurse etc.)
  4. 4.To describe terminally ill cancer patients and their relatives expectations of the health care system

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

1.5 years

First QC Date

January 7, 2008

Last Update Submit

January 10, 2011

Conditions

Keywords

Health Services ResearchFamily practice

Outcome Measures

Primary Outcomes (3)

  • Patients wish for place of death and place of terminal care fulfilled

    The patient will be asked about preference for place of death and place for terminal care at inclusion and a month later. At the time of death we will be able to establish weather the patient had his or her wishes fulfilled.

  • Relative amount of time spent in hospital in the terminal phase

    At the patients time of death we will be able to count number of days spent in hospital using the hospitals electronic patient files.

  • A subjective measure of the patients symptoms and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Palliative care [EORTC-QLQ-15-PAL])

    Will be measured at the time of inclusion and a month later.

Secondary Outcomes (9)

  • Patient's satisfaction regarding the services of the GP, district nurse and local hospital

    Will be measured at inclusion and one month later.

  • Patient's experiences regarding cooperation and information sharing in the health care system.

    Will be measured at inclusion and one month later.

  • Relative's satisfaction regarding the services of the GP, district nurse and local hospital.

    Will be measured at inclusion, one month later and 2 months after the patients death.

  • Relative's experiences regarding cooperation and information sharing in the health care system.

    Will be measured at inclusion, one month later and 2 months after the patients death.

  • Relative's experiences regarding the palliative treatment of the patient.

    Will be measured at inclusion, one month later and 2 months after the patients death.

  • +4 more secondary outcomes

Study Arms (3)

B

OTHER

90 terminally ill cancer patients will be referred to a specialist palliative care team at time of discharge.

Other: Referral to a specialist palliative care team.

C

OTHER

90 terminally ill cancer patients will be discharged from hospital with extra effort put into improving the communication between the hospital and the primary sector.

Other: Organisational intervention

A

NO INTERVENTION

90 terminally ill cancer patients will be discharged from hospital, receiving usual care.

Interventions

A shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector.

C

Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care.

B

Eligibility Criteria

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

You may qualify if:

  • In order to be included the patients have to be diagnosed as suffering from terminal cancer. The patients should also:
  • Be 18 years or older
  • Be able to speak and write Danish fluently
  • Give written and spoken consent
  • Be able to manage in their own home, with or without the help of carers and district nurses
  • Be informed about the diagnosis, also that it is incurable
  • Be registered as suffering from a terminal illness or fulfil the criteria for this -

You may not qualify if:

  • Patients are excluded if they:
  • Have a low level of cognitive skills, which makes it difficult for them to fill in a questionnaire
  • Are receiving oncologic treatment which requires attending an out-patients clinic regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Frede Olesen, Professor

    Research Unit for General Practice, Aarhus University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2010

Last Updated

January 11, 2011

Record last verified: 2011-01