A Shared Care Approach for Seriously Ill Cancer Patients Between General Practice, Discharge Department and a Specialist Palliative Care Team

This study has been withdrawn prior to enrollment.
(Recruitment problems has forced us to change the design of this study from a clinical trial to a comparative study of 3 different groups of patients.)
Sponsor:
Collaborators:
Research Unit for General Practice, Aarhus University
The Specialist Palliative Care Team, Dept. of Oncology, Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00594971
First received: January 7, 2008
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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. To describe consequences for patients, relatives and health care professionals of three different ways of organising palliative care
  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. 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. To describe terminally ill cancer patients and their relatives expectations of the health care system

270 terminally ill cancer patients will be invited to take part in the study. Data will be collected by interview with patients and questionnaires for patients, relatives and involved health care professionals.


Condition Intervention
Palliative Care
Neoplasms
Other: Organisational intervention
Other: Referral to a specialist palliative care team.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Shared Care Approach for Seriously Ill Cancer Patients Between General Practice, Discharge Department and a Specialist Palliative Care Team

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Patients wish for place of death and place of terminal care fulfilled [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Relative amount of time spent in hospital in the terminal phase [ Time Frame: At the patients time of death we will be able to count number of days spent in hospital using the hospitals electronic patient files. ] [ Designated as safety issue: No ]
  • 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]) [ Time Frame: Will be measured at the time of inclusion and a month later. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's satisfaction regarding the services of the GP, district nurse and local hospital [ Time Frame: Will be measured at inclusion and one month later. ] [ Designated as safety issue: No ]
  • Patient's experiences regarding cooperation and information sharing in the health care system. [ Time Frame: Will be measured at inclusion and one month later. ] [ Designated as safety issue: No ]
  • Relative's satisfaction regarding the services of the GP, district nurse and local hospital. [ Time Frame: Will be measured at inclusion, one month later and 2 months after the patients death. ] [ Designated as safety issue: No ]
  • Relative's experiences regarding cooperation and information sharing in the health care system. [ Time Frame: Will be measured at inclusion, one month later and 2 months after the patients death. ] [ Designated as safety issue: No ]
  • Relative's experiences regarding the palliative treatment of the patient. [ Time Frame: Will be measured at inclusion, one month later and 2 months after the patients death. ] [ Designated as safety issue: No ]
  • Subjective burden of relative (Burden Scale for Family Caregivers [BSFC]). [ Time Frame: Will be measured at inclusion and one month later. ] [ Designated as safety issue: No ]
  • GPs evaluation of the terminal phase. [ Time Frame: Will be measured after the patients death. ] [ Designated as safety issue: No ]
  • District nurses evaluation of the terminal phase. [ Time Frame: Will be measured after the patients death. ] [ Designated as safety issue: No ]
  • Hospital doctors evaluation of the terminal phase. [ Time Frame: Will be measured after the patients death. ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: April 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
B
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.
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.
C
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 shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector.
No Intervention: A
90 terminally ill cancer patients will be discharged from hospital, receiving usual care.

Detailed Description:

The intervention in the study is of organisational character. The patients will be randomised into two groups (groups B and C). A group of usual care patients will be included primary to the intervention (group A). The groups are:

A. Usual discharge with regular discharge letter to the GP. The GP, together with the community nurse, is responsible for the palliative care, including referral to a specialist palliative care team, hospice, hospital, etc., if necessary

B. 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

C. Discharge with extra effort put into improving the communication between the hospital and the GP. The GP will receive a phone call from the doctor who is discharging the patient, a detailed discharge letter, written information about the patient's type of cancer and acute oncological symptoms, name and phone number of the community nurse and name and phone number of a specialist in palliative medicine, who can be contacted for advice. This is a shared care model, where focus is on supporting the health care professionals.

  Eligibility

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

Inclusion Criteria:

In order to be included the patients have to be diagnosed as suffering from terminal cancer. The patients should also:

  1. Be 18 years or older
  2. Be able to speak and write Danish fluently
  3. Give written and spoken consent
  4. Be able to manage in their own home, with or without the help of carers and district nurses
  5. Be informed about the diagnosis, also that it is incurable
  6. Be registered as suffering from a terminal illness or fulfil the criteria for this -

Exclusion Criteria:

Patients are excluded if they:

  1. Have a low level of cognitive skills, which makes it difficult for them to fill in a questionnaire
  2. Are residents of a nursing home at the time of inclusion
  3. Are receiving oncologic treatment which requires attending an out-patients clinic regularly
  4. Already have established contact with a specialist palliative care team at the time of inclusion -
  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: NCT00594971

Sponsors and Collaborators
University of Aarhus
Research Unit for General Practice, Aarhus University
The Specialist Palliative Care Team, Dept. of Oncology, Aarhus University Hospital
Investigators
Study Director: Frede Olesen, Professor Research Unit for General Practice, Aarhus University
  More Information

No publications provided

Responsible Party: Professor Frede Olesen, Research Unit for General Practice, Aarhus University
ClinicalTrials.gov Identifier: NCT00594971     History of Changes
Other Study ID Numbers: 15273887, ISRCTN15273887
Study First Received: January 7, 2008
Last Updated: January 10, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Health Services Research
Family practice

ClinicalTrials.gov processed this record on October 19, 2014