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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170168
• Other study ID #: 2014/212
• Status: Completed
• Start date: November 2014
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 969
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• integrated palliative care program
a standardised care pathway, an educational programme and information to general public, patients and their carers

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Helse Møre og Romsdal HF, Norwegian University of Science and Technology, The Coordination Unit in the Orkdal region (SIO)

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported health-related quality of life	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
Other	place of death	if place of death is in accordance with patients' wish as reported at inclusion	3 years
Other	distribution of health care services usage	between specialist and community care	3 yeart
Other	total cost per patient		3 years
Other	share of specialist and community care costs		3 years
Primary	proportion of patient's time spent at home the last 3 months of life	time in days	3 years
Primary	carers' health related quality of life (HRQOL) 6 months after patient's death	as measured by the total score of the RAND-Short Form-36	3 years
Secondary	Number of home deaths		3 years
Secondary	Use of tumor directed treatment the last 3 months of life	radiotherapy and chemotherapy	3 years
Secondary	change over time in health care providers' knowledge and skills		3 years