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Trial registered on ANZCTR


Registration number
ACTRN12617001040358
Ethics application status
Approved
Date submitted
5/06/2017
Date registered
17/07/2017
Date last updated
17/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
FINnish PALliative care education trial. (FINPAL) to improve nursing home residents' quality of life
Scientific title
Educating staff in palliative care to improve quality of life and to reduce unnecessary hospitalizations among older people living in nursing homes. A cluster randomized single-blind controlled trial
Secondary ID [1] 291096 0
Nil
Universal Trial Number (UTN)
U1111-1192-5603
Trial acronym
FINPAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
terminal disease 301906 0
end-stage dementia 301907 0
end-stage COPD 301908 0
end-stage heart failure 301909 0
end-stage renal failure 301910 0
malignant cancer 301911 0
severe stroke 301912 0
Permanent institutionalization 303071 0
severe disablity 303547 0
Condition category
Condition code
Neurological 301572 301572 0 0
Dementias
Cancer 301573 301573 0 0
Any cancer
Cardiovascular 301574 301574 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Staff working in units which are randomized to intervention group will be able to take part to educational sessions in palliative and end-of-life care over 3 months. The focus of these sessions will be on the importance of familiar and safe surroundings in end-of-life care, encountering a dying patient and his/her family members, communication skills, advance care planning, assessing symptoms and symptom alleviation, working in a way to anticipate complications to avoid crises, life sustaining treatments, and the principles of good quality end-of-life care. The staff are encouraged to assess their residents' needs and wishes concerning to improve and maintain their well-being. The educational sessions include analyses of real-life decision-making regarding transfers to hospital emergency department. Different ways on how the care unit can be prepared to help residents suffering from acute symptoms, on how to relieve symptoms, and when to consult the physician of the unit or the emergency department, will be discussed. Local hospice-at-home care and home nursing services will be collaborated in the education. The possibilities of receiving treatment, assistance and services from hospice-at-home care to the sheltered housing communes, will be collaboratively decided. After receiving the education all the nursing staff and the consulting physicians will be encouraged to approach elderly residents and/or their family members for advance care planning.
The educational sessions will be performed in small groups of 10-20 staff members. The teaching method will be interactive encouraging discussions and questions. Sessions will encourage the staff members to share and learn from previous experiences and patient cases in their own units to help them enhance a more successful team work. Methods used will also include thorough assessments of real life situations to enable learning from successful cases as well as from possible past mistakes. These sessions are based on constructive learning theory and experiental learning of adult student. While the adult learner has already gained the basic knowledge of the subject, his/her educational needs are complementary to this basic knowledge. The education given to the nursing staff and doctors of the intervention group will include:
- symptom assessment, symptom relief and good palliative care
- how to anticipate complications and to avoid unnecessary crises in residents' condition
- assessing residents' needs and wishes concerning their well-being
- importance of teamwork, consulting strategies, working with hospice-at-home care
- hospital transfers and their effect on well-being of residents, acute situations: when is it necessary to refer a patient to emergency department;
- communication with patient and family members;
- advance care planning in practice; advance decision-making, Do-Not-Resuscitate and other physician orders for life sustaining treatments
- end-of-life care and support to family members.
The aducational sessions will be administered by geriatricians. There will be 4 or5 sessions depending on the educational needs of the staff. The educational needs will be assesssed by a survey before the education is administered. The education will be tailored according to these needs and wishes. The durations of each session will be 3 hours.
The fidelity and adherence of education will be assessed: how many sessions the members of the staff participate. Their feedback of the sessions will be assessed and in this way their motivation will be supported.
Intervention code [1] 297085 0
Other interventions
Comparator / control treatment
Normal care, information leaflet to staff on current care guidelines on terminal care.
Control group
Active

Outcomes
Primary outcome [1] 300980 0
Change in health-related quality of life according to 15D measure
Timepoint [1] 300980 0
From baseline to 6mo and 12 mo. The primary endpoint will be assessed over the 12 months using GEE models in statistics. Therefore, all participants having at least one assessment in addition to baseline will be included in final analyses.
Primary outcome [2] 300981 0
Number of hospital days. The patients' medical records will be used to retrieve by participants' social security number all hospital admissions and their duration in days during 24 months ..
Timepoint [2] 300981 0
During 24 months from baseline
Secondary outcome [1] 331321 0
Change in psychological well-being (PWB)
Timepoint [1] 331321 0
From baseline to 6mo and 12 mo
Secondary outcome [2] 331322 0
Changes in symptoms in ESAS (Edmonton symptom assessment system)
Timepoint [2] 331322 0
From baseline to 6mo and 12mo
Secondary outcome [3] 331323 0
Changes in pain (PAINAD)
Timepoint [3] 331323 0
From baseline to 6mo and 12mo
Secondary outcome [4] 331324 0
The number of care transitions and hospital admissions. This is a composite endpoint. Most of these will be hospital admissions whereas some will be transitions to other nursing homes or other assisted living facility. This information will be retrieved from social and medical records by participants' social security number..
Timepoint [4] 331324 0
During the twenty-four month follow-up
Secondary outcome [5] 331325 0
Use and total costs of health care resources. All information will be retrieved from particpant's medical and social records using his/her social security number. The cost of helath care services will be evaluated by average costs of respective national data.
Timepoint [5] 331325 0
During the twenty-four month follow-up
Secondary outcome [6] 331326 0
Satisfaction of family members / caregivers (SWC-EOLD)
Timepoint [6] 331326 0
6mo and 12 mo
Secondary outcome [7] 331327 0
Mortality
Timepoint [7] 331327 0
During 24 mo follow-up
Secondary outcome [8] 334334 0
Change in the number of symptoms and their severity in MDS-RAI
Timepoint [8] 334334 0
from baseline to 6mo and 12mo

Eligibility
Key inclusion criteria
- Finnish speaking
- Permanent resident in a nursing home/assisted living facility in city of Helsinki/Vantaa;
- at least one condition evaluated to affect severely health and prognosis (severe dementia, heart failure, COPD, DM, coronary heart disease, cancer, cachexia, chronic inflammation, frailty, disablity, malnutrition)
- Volunteer and able to give informed consent. In case of moderate to severe cognitive impairment (CDR 2-3) the consent will be provided by the closest proxy.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- <65years old
- evaluated prognosis >one year

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation of nursing homes/assisted living facilities using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomized trial :the nursing homes will be randomized instead of individual patients. The whole staff of intervention wards/nursing homes/assisted living facilities will will receive education
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample sizing is based on 15D scoring change. Sample size was estimated as follows: In this population the standard deviation (SD) of 15D score is presumed to be 0.11 (Pitkala et al. 2008), thus a clinically significant change in the 15D score is presumed to be 0.04 (Sintonen 2001). If type I error is 5% and power 80%, to fill these presumptions the sample size would have to be 112 participants per group. As the study and follow-up takes twenty-four months, statistically approximately 40% of the residents, who usually have comorbidities, will die during the follow-up period. Because of the expected high percentage of drop-outs, we will recruit approximately 150 individuals per group to reach at least two assessment points in 112 participants. With this number of participants, we will be able to show a mean 0.8 day difference of hospitalizations between the intervention and control groups, if we assume an SD 2.3 in hospital days (80% power, type I error 5%).
All participants assessed at baseline and at least at one other time point will be included in the data analyses of the changes in 15D. All randomized participants will be included in the hospital utilization and cost analyses (intention-to-treat). When presenting the results in averages, the median and arithmetic means are used. As expressing variabilities, the standard deviation and the range will be used. In nominally scaled variables distributions will be expressed in proportions. Differences between groups at start will be measured statistically in continuous and normally distributed variables using the t-test. Ordinal scale variables or variables which do not fulfill the parametric testing presumptions will be statistically measured with Mann-Whitney’s U-test. Testing the nominal scale variables will be done using the X²-test or the Fisher’s exact test.
Differences between groups in changes of repeatedly measured 15D scores will be tested with generalized estimating equation (GEE) models. Repeated measures will be analyzed using mixed-effect models with the appropriate contrast. As the data for services and costs will be highly skewed, bias-corrected and accelerated bootstrap estimation will be used to derive 95% CIs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8862 0
Finland
State/province [1] 8862 0

Funding & Sponsors
Funding source category [1] 295536 0
Hospital
Name [1] 295536 0
EVO funding by Helsinki University Hospital
Address [1] 295536 0
Helsinki University Central Hospital
Yhtymähallinto / Tutkimus
PO Box 20
00029 Helsinki University Central Hospital
Finland
Country [1] 295536 0
Finland
Primary sponsor type
Hospital
Name
Helsinki University Central Hospital
Address
Helsinki University Central Hospital
Yhtymähallinto / Tutkimus
PO Box 20
00029 Helsinki University Central Hospital
Finland
Country
Finland
Secondary sponsor category [1] 294354 0
None
Name [1] 294354 0
Address [1] 294354 0
Country [1] 294354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296857 0
Helsinki University Hospital, Coordinating Ethical Committee
Ethics committee address [1] 296857 0
Biomedicum 2 C, 3rd floor
Tukholmankatu 8 C
Helsinki University Hospital
00029 Helsinki University Hospital
Finland
Ethics committee country [1] 296857 0
Finland
Date submitted for ethics approval [1] 296857 0
27/02/2017
Approval date [1] 296857 0
16/03/2017
Ethics approval number [1] 296857 0
HUS/1212/2016

Summary
Brief summary
The aim of this cluster randomized, controlled trial (RCT) is to investigate whether educational intervention in palliative care directed to nursing staff can reduce hospital transfers and improve the health-related quality-of-life (HRQoL) of older people living in assisted living facilities and nursing homes in Helsinki and Vantaa. We aim to develop a training model that can be used widely in sheltered housing facilities to improve older residents' end-of-life care.
The study will enroll 300 residents of sheltered housing with 24-hour assistance from the cities of Helsinki and Vantaa. The inclusion criteria are: 65+y; Finnish speaking, permanent resident in a sheltered housing, and diagnosis/condition affecting severely health, functioning and prognosis. The participants and their caregivers will be interviewed at baseline, at 6 and 12 months. At 24 months the use of hospitals and other services as well as care transitions will be retrieved from central registers. Primary outcome measures will be HRQoL by 15D measure and use of hospital days during 24-month follow-up. Secondary outcomes will be number of hospital admissions and other care transitions, use of health services, symptoms by SM-EOLD scale, pain by PAINAD, well-being by PWB, and caregiver satisfaction by SWC-EOLD. The study nurses will be blinded to randomization. The sheltered housing units will be randomized as units (cluster randomization) to avoid contamination of intervention on control participants. The intervention is an educational package over 3 months including: symptom assessment /alleviation, good palliative care, anticipation of complications to avoid unnecessary crises, assessing residents' needs and wishes concerning their well-being, teamwork, consulting strategies, working with hospice-at-home care, hospital transfers and their effect on well-being of residents, communication with patient and family members, advance care planning, DNR and other orders for life sustaining treatments, end-of-life care and support to family members. The control participants will be treated in normal care in their own wards and own consulting physicians. The trial will start in fall 2017, the follow-up will last until spring 2020; the analyses and reports will be completed in 2021.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72242 0
Prof Kaisu Pitkälä
Address 72242 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland
Country 72242 0
Finland
Phone 72242 0
+358503385546
Fax 72242 0
Email 72242 0
kaisu.pitkala@helsinki.fi
Contact person for public queries
Name 72243 0
Prof Kaisu Pitkälä
Address 72243 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland
Country 72243 0
Finland
Phone 72243 0
+358503385546
Fax 72243 0
Email 72243 0
kaisu.pitkala@helsinki.fi
Contact person for scientific queries
Name 72244 0
Prof Kaisu Pitkälä
Address 72244 0
University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland
Country 72244 0
Finland
Phone 72244 0
+358503385546
Fax 72244 0
Email 72244 0
kaisu.pitkala@helsinki.fi

No information has been provided regarding IPD availability
Summary results
No Results