Plain English Summary
Background and study aims
The number of older people with multiple chronic conditions and complex health needs will increase rapidly over the coming decades. Effective and cost-effective patient care models are needed to support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes.
Who can participate?
Home-dwelling older adults (age 75 years or above), that use at least seven prescribed medicines, dietary supplements or lotions/creams.
What does the study involve?
The intervention comprises an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. The usual care group patients (control group) receive usual care at the health centre. Quality of Life (SF-36) and physical performance are measured at the baseline and at the 1-year and 2-year follow-ups for all the participants.
What are the possible benefits and risks of participating?
Taking part could help improve future care of the older people. For intervention group the benefits are e.g. that comprehensive medication and health reviews are performed, care and medication plans are created/updated, and named nurse will work as a care coordinator for them. There are no anticipated risks to taking part in the study, but quality of life and physical performance tests will take some time.
Where is the study run from?
The study is conducted in collaboration with Tornio primary health care centre, (setting and intervention providers; GPs, nurses and a pharmacist), Alatornio community pharmacy (intervention provider; a pharmacist), and the Faculty of Pharmacy, University of Helsinki (intervention providers and researchers).
When is the study starting and how long is it expected to run for?
The study started in October 2014 and run until May 2018.
Who is funding the study?
1. The Foundation of Vappu and Oskari Yli-Perttula (Finland) (Funding of the research project execution and researchers travel costs)
2. Tornio city (Finland) (Funding of the research project execution)
3. The Association of the Finnish Pharmacies (AFP) (Finland) (One year funding of Heini Kari’s doctoral studies)
The researchers are independent of the funders.
Who is the main contact?
Heini Kari
heini.kari@helsinki.fi
Trial website
Contact information
Type
Scientific
Primary contact
Ms Heini Kari
ORCID ID
https://orcid.org/0000-0002-2061-2552
Contact details
Division of Pharmacology and Pharmacotherapy (7th floor)
Faculty of Pharmacy
Viikinkaari 5 E (PL 56)
University of Helsinki
Helsinki
Finland
Helsinki
00014
Finland
+358 (29)41911
heini.kari@helsinki.fi
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
OMA21
Study information
Scientific title
Care Plan 2100 - Developing and evaluating a people-centred care model
Acronym
PCCM
Study hypothesis
People-centred care has positive effect on physical functioning and quality of life in older adults with lower costs.
Ethics approval
Approved 28/04/2014, regional North Ostrobothnia Hospital District (Finland) ethics committee (PPSHP:n alueellinen eettinen toimikunta, Yhtymähallinto N5 (1 krs.), PL 10, 90029 OYS, Finland; +35840 773 1529, minna.makiniemi@ppshp.fi), ref: 32/2014
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format
Condition
Care for older people
Intervention
Effectiveness and cost-utility of a people-centre care model in primary care for multimorbid, community-living older people aged ≥75 years are compared to usual care in the health centre (RCT). The intervention comprises an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support.
Intervention group: The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support.
Usual care group (control group): The usual care group patients received usual care at the health centre. Usual care is accessed and utilised by the patient on her/his own initiative. However, the electronic medication lists of the patients in the usual care group were reviewed by a pharmacist to ensure there were no serious interactions or other potential drug-related problems that could have been life-threatening. In such a case, the patient would have been contacted, directed to appropriate healthcare services and withdrawn from the RCT.
Quality of Life (SF-36) and physical performance are measured at the baseline and at the 1-year and 2-year follow-ups. The SF-36 data are transformed into SF-6D scores to calculate quality-adjusted life years (QALYs). Healthcare resource use are collected and transformed into costs and the ICER is calculated.
Follow-up time for each group was 2 years.
Randomisation: An envelope method was used, in which an envelope was randomly selected from a box of randomly mixed closed envelopes, containing the group designation, and opened, and the group allocation was recorded.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Quality of Life (SF-36) and physical performance are measured at the baseline and at the 1-year and 2-year follow-ups. The SF-36 data are transformed into SF-6D scores to calculate quality-adjusted life years (QALYs).
2. Healthcare resource use is collected and transformed into costs and the ICER is calculated at the 1-year and 2-year follow-ups
Secondary outcome measures
Physical dimension component summary in the SF-36 at the baseline and at the 1-year and 2-year follow-ups
Overall trial start date
31/08/2013
Overall trial end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1.Home-dwelling outpatients
2. Aged ≥ 75 years
3. ≥ 7 prescribed medicines, dietary supplements or lotions/creams identified through the health centre patient records
4. Living in Tornio
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
300
Total final enrolment
323
Participant exclusion criteria
1. Appointed a guardian of interests
2. Living in a care home
3. Appointed to a hospital ward at the time of identification
4. Geriatrician-completed clinical medication review in the last two years
Recruitment start date
01/10/2014
Recruitment end date
31/05/2016
Locations
Countries of recruitment
Finland
Trial participating centre
Tornio Primary Health Care Centre
Sairaalakatu 1
Tornio
95400
Finland
Sponsor information
Organisation
University of Helsinki
Sponsor details
Viikinkaari 5 E (PL 56)
Helsinki
00014
Finland
+358 440935566
marjo.yliperttula@helsinki.fi
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Foundation of Vappu and Oskari Yli-Perttula
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Tornio city
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Association of the Finnish Pharmacies (AFP)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as participant consent forms and ethics approval did not include permission for open public access data, and due to change of individual participant identification.
Intention to publish date
31/08/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list