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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Other: integrated palliative care program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orkdal region patients<br>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<br>* a standardised care pathway, an educational programme and information to general public, patients and their carers<br>|
| Romsdal county patients<br>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<br>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<br>* a standardised care pathway, an educational programme and information to general public, patients and their carers<br>|
| Romsdal county carers<br>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<br>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<br>* a standardised care pathway, an educational programme and information to general public, patients and their carers<br>|
| Romsdal county health care providers<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patient's time spent at home the last 3 months of life | time in days | 3 years | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health services, Models, organizational, Referral and consultation, Palliative medicine, Terminal care