Clinical trial NCT02170168: The Orkdal Model. Collaboration Between Specialist and Community Care Within Palliative Cancer Care
Official title: The Orkdal Model. Development, Implementation and Evaluation of Collaboration Between Specialist and Community Care Within Palliative Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Community health services
Models, organizational
Referral and consultation
Palliative medicine
Terminal care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: The Coordination Unit in the Orkdal region (SIO)
name: Helse Møre og Romsdal HF
name: Norwegian University of Science and Technology
First posted: 2014-06-23
Enrollment: 969
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patient's time spent at home the last 3 months of life
timeFrame: 3 years
measure: carers' health related quality of life (HRQOL) 6 months after patient's death
timeFrame: 3 years
Secondary outcomes:
measure: Number of home deaths
timeFrame: 3 years
measure: Use of tumor directed treatment the last 3 months of life
timeFrame: 3 years
measure: change over time in health care providers' knowledge and skills
timeFrame: 3 years
Other outcomes:
measure: Patient reported health-related quality of life
timeFrame: 3 years
measure: place of death
timeFrame: 3 years
measure: distribution of health care services usage
timeFrame: 3 yeart
measure: total cost per patient
timeFrame: 3 years
measure: share of specialist and community care costs
timeFrame: 3 years
Locations:
city: Agdenes
country: Norway
facility: Agdenes community care
city: Aukra
country: Norway
facility: Aukra community care
city: Eide
country: Norway
facility: Eide community care
city: Fræna
country: Norway
facility: Fræna community care
city: Frøya
country: Norway
facility: Frøya community care
city: Halsa
country: Norway
facility: Halsa community care
city: Hemne
country: Norway
facility: Hemne community care
city: Hitra
country: Norway
facility: Hitra community care
city: Meldal
country: Norway
facility: Meldal community care
city: Midsund
country: Norway
facility: Midsund community care
city: Molde
country: Norway
facility: Molde community care
city: Molde
country: Norway
facility: Molde Hospital
city: Nesset
country: Norway
facility: Nesset community care
city: Oppdal
country: Norway
facility: Oppdal community care
city: Orkdal
country: Norway
facility: Oppdal community care
city: Orkdal
country: Norway
facility: Orkdal Hospital
city: Rauma
country: Norway
facility: Rauma community care
city: Rennebu
country: Norway
facility: Rennebu community care
city: Rindal
country: Norway
facility: Rindal community care
city: Skaun
country: Norway
facility: Skaun community care
city: Snillfjord
country: Norway
facility: Snillfjord community care
city: Sunndal
country: Norway
facility: Sunndal community care
city: Surnadal
country: Norway
facility: Surnadal community care
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Vestnes
country: Norway
facility: Vestnes community care
Study officials:
affiliation: St. Olavs Hospital
name: Jo-Åsmund Lund, MD PhD
role: STUDY_DIRECTOR
References: