Condition category
Not Applicable
Date applied
10/06/2020
Date assigned
11/06/2020
Last edited
11/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://university.helsinki.fi/en

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

Publication citations

Additional files

Editorial Notes

11/06/2020: Trial’s existence confirmed by North Ostrobothnia Hospital District (Finland) ethics committee.