The Orkdal Model. Collaboration Between Specialist and Community Care Within Palliative Cancer Care

April 12, 2023 updated by: St. Olavs Hospital

The Orkdal Model. Development, Implementation and Evaluation of Collaboration Between Specialist and Community Care Within Palliative Cancer Care

The overall aim of this project is to deliver better health care services through improved coordination of cancer care within specialist care (at the local hospital Orkdal Hospital) and community care (13 municipalities in the Orkdal region, Norway), and between these two levels in the health care system. "The Orkdal model" is developed and will be implemented and evaluated within cancer care. Cancer patients living in one of the 12 municipalities participating in the formal collaboration "Samhandlingsenheten i Orkdalsregionen" (SIO), or the municipality of Oppdal, having metastatic and/or loco-regional disease will be included in the study. Carers and health care providers will be included as well. Results from this project will be transferable to other parts of Norway and/or to other countries as well as to patients with other diagnoses causing complex conditions, such as chronic heart-, lung- and neurological disease.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will be a prospective controlled observational pre-post study. The intervention consists of three parts: a standardised care pathway, an educational programme and information to general public, patients and their carers. Data from patients, carers and health care providers (physicians, nurses and nurse assistants) will be collected before the model is implemented (pre-intervention part) and after final implementation (post-intervention part). In addition, a comparison with a similar patient population, carers and health care providers will be conducted. A local hospital in the county of Romsdal and community care in the same region will be used as control.

Added January 2020: The study was in 2018 extended to also evaluate the effect of implementing "advance care planning" in the county of Møre and Romsdal. Møre and Romsdal started implementation of "advance care planning" in January 2018. The evaluation of "advance care planning in Møre and Romsdal" has the same endpoints as the evaluation of the Orkdal model trial.

Added December 17th, 2021: Inclusion of participants (patients, carers and healthcare professionals) is from Sept 2018 to March 2021. Follow-up ends in Sept. 2022.

Study Type

Observational

Enrollment (Actual)

969

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Agdenes, Norway
        • Agdenes community care
      • Aukra, Norway
        • Aukra community care
      • Eide, Norway
        • Eide community care
      • Fræna, Norway
        • Fræna community care
      • Frøya, Norway
        • Frøya community care
      • Halsa, Norway
        • Halsa community care
      • Hemne, Norway
        • Hemne community care
      • Hitra, Norway
        • Hitra community care
      • Meldal, Norway
        • Meldal community care
      • Midsund, Norway
        • Midsund community care
      • Molde, Norway
        • Molde Hospital
      • Molde, Norway
        • Molde community care
      • Nesset, Norway
        • Nesset community care
      • Oppdal, Norway
        • Oppdal community care
      • Orkdal, Norway
        • Oppdal community care
      • Orkdal, Norway
        • Orkdal Hospital
      • Rauma, Norway
        • Rauma community care
      • Rennebu, Norway
        • Rennebu community care
      • Rindal, Norway
        • Rindal community care
      • Skaun, Norway
        • Skaun community care
      • Snillfjord, Norway
        • Snillfjord community care
      • Sunndal, Norway
        • Sunndal community care
      • Surnadal, Norway
        • Surnadal community care
      • Trondheim, Norway
        • St Olavs Hospital
      • Vestnes, Norway
        • Vestnes community care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients in need of palliative care, inhabitants of one of 22 municipalities in Central Norway, carers (1 per patient) and health care providers (community care and 2 regional hospitals)

Description

Inclusion Criteria (Patients):

  • Advanced loco-regional disease and/or metastatic cancer disease
  • For the intervention group in the Orkdal region: Inhabitant of one of the following thirteen districts: Surnadal, Halsa, Rindal, Hemne, Orkdal, Frøya, Hitra, Snillfjord, Agdenes, Meldal, Rennebu, Skaun, and Oppdal
  • For the intervention group in the Romsdal region: Inhabitiant of one of the following nine districts: Aukra, Molde, Eide, Vestnes, Sunndal, Fræna, Midsund, Nesset, Rauma
  • Acceptance of participation, based on information about the study and that participation is voluntary. Documented by a signed consent form.
  • Able to comply with the study procedures
  • Able to read and write Norwegian

Inclusion criteria (Carers) (a carer a person identified as such by the patient)

  • the patient is eligible for the study
  • the patient has given his or her consent to allow the study nurse to approach the carer to participate in the study
  • the patient has identified the carer to be approached
  • acceptance of participation, based on information about the study and that participation is voluntary. Documented by a signed consent form.

Inclusion Criteria (Health care providers)

  • has accepted to participate in the study
  • Acceptance of participation, based on information about the study and that participation is voluntary. Documented by an electronically signed consent form.

Exclusion Criteria (Patients):

  • Receiving anti-cancer treatment with curative intent

Exclusion Criteria (Carers)

  • not able to complete the assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orkdal region patients
cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities
a standardised care pathway, an educational programme and information to general public, patients and their carers
Romsdal county patients
control palliative care cancer patients in standard care, i.e. a local hospital in the county of Møre and Romsdal, Molde Hospital, and nine districts
Orkdal region carers
carers of cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities
a standardised care pathway, an educational programme and information to general public, patients and their carers
Romsdal county carers
carers of cancer patients receiving standard care, i.e. in a local hospital in the county of Møre and Romsdal, Molde Hospital, and community care in nine districts
Orkdal region health care providers
Health care providers for cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities
a standardised care pathway, an educational programme and information to general public, patients and their carers
Romsdal county health care providers
Health care providers for cancer patients receiving standard care, i.e. in a local hospital in the county of Møre and Romsdal, Molde Hospital, and community care in nine districts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patient's time spent at home the last 3 months of life
Time Frame: 3 years
time in days
3 years
carers' health related quality of life (HRQOL) 6 months after patient's death
Time Frame: 3 years
as measured by the total score of the RAND-Short Form-36
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of home deaths
Time Frame: 3 years
3 years
Use of tumor directed treatment the last 3 months of life
Time Frame: 3 years
radiotherapy and chemotherapy
3 years
change over time in health care providers' knowledge and skills
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported health-related quality of life
Time Frame: 3 years
measured by the total score of the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC QLQ C15
3 years
place of death
Time Frame: 3 years
if place of death is in accordance with patients' wish as reported at inclusion
3 years
distribution of health care services usage
Time Frame: 3 yeart
between specialist and community care
3 yeart
total cost per patient
Time Frame: 3 years
3 years
share of specialist and community care costs
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jo-Åsmund Lund, MD PhD, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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