Effectiveness and cost-effectiveness of comprehensive care for older people in primary care
| ISRCTN | ISRCTN89081244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89081244 |
| Secondary identifying numbers | OMA21 |
- Submission date
- 10/06/2020
- Registration date
- 11/06/2020
- Last edited
- 19/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Division of Pharmacology and Pharmacotherapy (7th floor)
Faculty of Pharmacy
Viikinkaari 5 E (PL 56)
University of Helsinki, Helsinki, Finland
Helsinki
00014
Finland
 ORCID ID |
0000-0002-2061-2552 |
|---|---|
| Phone | +358 (29)41911 |
| heini.kari@helsinki.fi |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | Care Plan 2100 - Developing and evaluating a people-centred care model |
| Study acronym | PCCM |
| Study objectives | People-centred care has positive effect on physical functioning and quality of life in older adults with lower costs. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 31/08/2013 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 323 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2014 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Finland
Study participating centre
Tornio
95400
Finland
Sponsor information
University/education
Viikinkaari 5 E (PL 56)
Helsinki
00014
Finland
| Phone | +358 440935566 |
|---|---|
| marjo.yliperttula@helsinki.fi | |
| Website | https://university.helsinki.fi/en |
"ROR" |
https://ror.org/040af2s02 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | People-centred care model (PCCM) development for RCT, Care Plan 2100 | 05/02/2022 | 19/07/2023 | Yes | No |
| Results article | 30/06/2022 | 19/07/2023 | Yes | No |
Editorial Notes
19/07/2023: Two publication references added.
11/06/2020: Trial’s existence confirmed by North Ostrobothnia Hospital District (Finland) ethics committee.
