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Completed

NCT Number: NCT02170168

The Orkdal Model. 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Agdenes community care, Agdenes, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

integrated palliative care program

Other

a standardised care pathway, an educational programme and information to general public, patients and their carers

Primary outcomes

  1. proportion of patient's time spent at home the last 3 months of life

    Time frame: 3 years

    time in days

  2. 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

Secondary outcomes

  1. Number of home deaths

    Time frame: 3 years

  2. Use of tumor directed treatment the last 3 months of life

    Time frame: 3 years

    radiotherapy and chemotherapy

  3. change over time in health care providers' knowledge and skills

    Time frame: 3 years

Other outcomes

  1. 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

  2. place of death

    Time frame: 3 years

    if place of death is in accordance with patients' wish as reported at inclusion

  3. distribution of health care services usage

    Time frame: 3 yeart

    between specialist and community care

  4. total cost per patient

    Time frame: 3 years

  5. share of specialist and community care costs

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Helse Møre og Romsdal HF
  • Norwegian University of Science and Technology
  • The Coordination Unit in the Orkdal region (SIO)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2014
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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