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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]

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

end-stage dementia

end-stage COPD

end-stage heart failure

end-stage renal failure

malignant cancer

severe stroke

Permanent institutionalization

severe disablity

Condition category

Condition code

Neurological

Dementias

Cancer

Any cancer

Cardiovascular

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]

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]

Change in health-related quality of life according to 15D measure

Timepoint [1]

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]

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]

During 24 months from baseline

Secondary outcome [1]

Change in psychological well-being (PWB)

Timepoint [1]

From baseline to 6mo and 12 mo

Secondary outcome [2]

Changes in symptoms in ESAS (Edmonton symptom assessment system)

Timepoint [2]

From baseline to 6mo and 12mo

Secondary outcome [3]

Changes in pain (PAINAD)

Timepoint [3]

From baseline to 6mo and 12mo

Secondary outcome [4]

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]

During the twenty-four month follow-up

Secondary outcome [5]

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]

During the twenty-four month follow-up

Secondary outcome [6]

Satisfaction of family members / caregivers (SWC-EOLD)

Timepoint [6]

6mo and 12 mo

Secondary outcome [7]

Mortality

Timepoint [7]

During 24 mo follow-up

Secondary outcome [8]

Change in the number of symptoms and their severity in MDS-RAI

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/09/2017

Actual

Date of last participant enrolment

Anticipated

30/11/2017

Actual

Date of last data collection

Anticipated

31/05/2020

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment outside Australia

Country [1]

Finland

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

EVO funding by Helsinki University Hospital

Address [1]

Helsinki University Central Hospital
Yhtymähallinto / Tutkimus
PO Box 20
00029 Helsinki University Central Hospital
Finland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Helsinki University Hospital, Coordinating Ethical Committee

Ethics committee address [1]

Biomedicum 2 C, 3rd floor
Tukholmankatu 8 C
Helsinki University Hospital
00029 Helsinki University Hospital
Finland

Ethics committee country [1]

Finland

Date submitted for ethics approval [1]

27/02/2017

Approval date [1]

16/03/2017

Ethics approval number [1]

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

Prof Kaisu Pitkälä

Address

University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland

Country

Finland

Phone

+358503385546

Fax

kaisu.pitkala@helsinki.fi

Contact person for public queries

Name

Prof Kaisu Pitkälä

Address

University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland

Country

Finland

Phone

+358503385546

Fax

kaisu.pitkala@helsinki.fi

Contact person for scientific queries

Name

Prof Kaisu Pitkälä

Address

University of Helsinki
Department of General Practice
PO Box 20
00014 University of Helsinki
Finland

Country

Finland

Phone

+358503385546

Fax

kaisu.pitkala@helsinki.fi

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Email
23485	Study protocol	Lamppu P, Laurila JV, Laakkonen ML, Finne-Soveri H, Pitkälä KH. Training nursing home staff to improve residents' end-of-life care - design and baseline findings from a randomized, controlled trial. Eur Geriatr Med 2019; 10:649–657.
23486	Ethical approval		kaisu.pitkala@kolumbus.fi
23487	Informed consent form		kaisu.pitkala@kolumbus.fi

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Training Staff in Long-Term Care Facilities-Effects on Residents' Symptoms, Psychological Well-Being, and Proxy Satisfaction.	2021	https://dx.doi.org/10.1016/j.jpainsymman.2021.03.020
Embase	Training nursing home staff to improve residents' end-of-life care: design and baseline findings from a randomized controlled trial.	2019	https://dx.doi.org/10.1007/s41999-019-00200-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically