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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Norway
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: integrated palliative care program
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
Other: integrated palliative care program
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
Other: integrated palliative care program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology
Helse Møre og Romsdal HF
The Coordination Unit in the Orkdal region (SIO)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/212

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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