Nurse-Patient RelationsPFPNCT04833153
Continuing Education Intervention Named "Person First - Please"
A study testing Person-First - Please (PFP) in people with Nurse-Patient Relations, run by Mari Pakkonen at 1 site in Finland.
Trial summary
The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC. Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- Person-First - Please (PFP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 30 Aug 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nurses (RNs, Licensed Practice Nurses, Caregiver Assistants) who works in older people LTC. The inclusion criteria for nurses are that they work permanently or on a long-term deputy (at least 6 months) in units.
- The criteria for older people participating alone are that older people have enough cognitive capacity assessed by managers of the units. The criteria for next of kin participating is they will visit at least weekly in LTC.
Who cannot join
- short- time deputy nurses
- older people in terminal care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuing Education Intervention "Person First - Please" of Person-Centred Care Targeted to Nurses in Older People Long-term Care
The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC.
Research question 1:
Read more
What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC?
Hypothesis for research question 1 are:
- Nurses in intervention group will have higher level of competence of PCC than control.
Research question 2:
How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people?
Hypothesis for research question 2 are:
- PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people.
- The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people.
- The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people.
Read the detailed description
The study takes place in older people long-term care on two cities in western part of Finland. The long-term care units are similar as stuff structure, nurse/resident ration, working ideology and quality management.
The research design is quasi-experimental research with pre- and post- test measurements in the intervention and control groups. The intervention group will follow the protocol and the control group participants will follow the usually care. Data are being collected at baseline, immediately after 10 weeks intervention and at follow-up 6 weeks after intervention.
Continuing education named "Person First - Please" (PFP) based on Person-Centered Care (PCC) Practice Framework and Theory of Collective Competence and it consist of four modules: Information, Person, Autonomy and Dignity. Information module will take one hour in the first intervention week, and it will include information about the study; informed consent; short clarification about concept PCC and prerequisites for PCC. Tree other modules takes 4 hours contact with researcher in every three weeks.
Power analyses for the sample size showed that for 0.8 effect size, power of 0.8 and statistical significance of 0.05 with three main hypotheses, for intervention group n=64 and for control group n=128. ICC of 0.1 was used based on previous sample of the primary outcome measurement.
The sampling based on cluster sampling. Two cities will be constituting the clusters in western part of Finland. From these cities will be selected first all public long-term care units for the older people. To avoid contamination, one of the cities will be selected to participate in the intervention and the other in the control.
Participants in the study consist of nurses (Registered Nurses, Licensed Practice Nurses, Caregiver Assistants) who work in older people LTC and older people from the same units participate alone or with their next of kin.
Nurses background questions are age, education, working experience. Older people and next of kin background questions are age, length of the living in LTC, relationship, number of visits per week in LTC. The effectiveness of an intervention is measured by validated measurements that have been properly licensed.
The data will be analysed by latest version of the Software Platform for Statistical Analysis (SPSS). Descriptive statistic will be calculated for the numerical and categorical data. The normal distribution of the data and 95% confidence intervals will be calculated for the numerical and categorical data. Intervention and control group will be statistically compared, and differences will be measured at each time point. At the baseline will be ensure the similarity of intervention and control group for background variables. Cross-tabulations will be done for categorical and numerical variables. The sum variable of the measurements during the three different measurement time will be analysed using hierarchical linear mixed models will compare the changes over time between the groups.
Each participant will be informed before about the purpose of the study, issues related to research ethics, reporting of the findings and they will sign informed consent. Since the study involves research participants who are vulnerable due to cognitive impairment, researcher have clear protocol and special attention will be paid to ethical issues during the study.
- Conditions
- Nurse-Patient Relations
- Being tested
- Person-First - Please (PFP)
- Keywords
- Person-centred care, Continuing education, Long-term care, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-First - Please (PFP)Behavioural
PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher.
| Study group | Role | What they receive |
|---|---|---|
| PFP intervention | Experimental | PFP 10 week continuing education intervention Receives: Behavioral: Person-First - Please (PFP) |
| Control arm | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nurses PCC competency
The competence data will be collected by the Patient-centred Care Competency (PCC) scale as primary outcome. The PCC scale consists of 17 items with 5-point Likert scale (1 = minimal, 2 = below average, 3 = average, 4 = good, 5 = excellent), divided subscales: respecting patients' perspectives, promoting patient involvement in care processes, providing for patient comfort, and advocating for patients.
Measured: baseline - after the intervention - 6 week follow up
Secondary outcomes (2)
Changes in PCC climate in lens of nurses, older people and next of kin
The PCC climate data will be collected by Person-centred questionnaire (PCQ-S) staff version and (PCQ-P) patient version (6- point Likert scale: 0 = No, I disagree completely; 1 = No, I disagree; 2 = No, I partly disagree, 3 = Yes, I partly agree; 4 = Yes, I agree; 5 = Yes, I agree completely). Scales are divided subscales: hospitality, safety and everydayness. Data will be collect from nurses, older people and their next of kin.
Measured: baseline - after the intervention - 6 week follow up
Evaluation of the continuing education named PFP in lens of the nurses
A feasibility tool has been developed for this intervention. Data will be collected from the nurses in end of the every PFP-modules, excluded information module.
Tool consist of the subscales: content of the PFP; evaluation about the pedagogical methods; utilization of the PFP; evaluation of the PFP dosage; evaluation of the trainer. There is 5-point Likert scale: 1 = disagree; 2 = partly disagree; 3 = no disagree/no agree; 4 = agree; 5 = agree completely.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start30 Aug 2021
- Primary completion2 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mari Pakkonen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mari Pakkonen, University of Turku
- Investigators
- Suhonen, Professor, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833153
- Sponsor's protocol ID
- mjpakk73645
- Acronym
- PFP
- Status last verified
- Nov 2022
- First submitted
- 13 Mar 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: small sample size and vulnerable participants
Publications
Pakkonen M, Stolt M, Edvardsson D, Pasanen M, Suhonen R. Person-centred care competence and person-centred care climate described by nurses in older people's long-term care-A cross-sectional survey. Int J Older People Nurs. 2023 May;18(3):e12532. doi: 10.1111/opn.12532. Epub 2023 Mar 14.
PubMed 36918384
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Education Intervention "Person First - Please" of Person-Centred Care Targeted to Nurses in Older People Long-term Care
- ClinicalTrials.gov ID
- NCT04833153
- Acronym / sponsor ID
- PFP / mjpakk73645
- Conditions
- Nurse-Patient Relations
- Keywords
- Person-centred care, Continuing education, Long-term care, Older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mari PakkonenUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC.
Research question 1:
What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC?
Hypothesis for research question 1 are:
- Nurses in intervention group will have higher level of competence of PCC than control.
Research question 2:
How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people?
Hypothesis for research question 2 are:
- PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people.
- The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people.
- The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people.
Detailed description
The study takes place in older people long-term care on two cities in western part of Finland. The long-term care units are similar as stuff structure, nurse/resident ration, working ideology and quality management.
The research design is quasi-experimental research with pre- and post- test measurements in the intervention and control groups. The intervention group will follow the protocol and the control group participants will follow the usually care. Data are being collected at baseline, immediately after 10 weeks intervention and at follow-up 6 weeks after intervention.
Continuing education named "Person First - Please" (PFP) based on Person-Centered Care (PCC) Practice Framework and Theory of Collective Competence and it consist of four modules: Information, Person, Autonomy and Dignity. Information module will take one hour in the first intervention week, and it will include information about the study; informed consent; short clarification about concept PCC and prerequisites for PCC. Tree other modules takes 4 hours contact with researcher in every three weeks.
Power analyses for the sample size showed that for 0.8 effect size, power of 0.8 and statistical significance of 0.05 with three main hypotheses, for intervention group n=64 and for control group n=128. ICC of 0.1 was used based on previous sample of the primary outcome measurement.
The sampling based on cluster sampling. Two cities will be constituting the clusters in western part of Finland. From these cities will be selected first all public long-term care units for the older people. To avoid contamination, one of the cities will be selected to participate in the intervention and the other in the control.
Participants in the study consist of nurses (Registered Nurses, Licensed Practice Nurses, Caregiver Assistants) who work in older people LTC and older people from the same units participate alone or with their next of kin.
Nurses background questions are age, education, working experience. Older people and next of kin background questions are age, length of the living in LTC, relationship, number of visits per week in LTC. The effectiveness of an intervention is measured by validated measurements that have been properly licensed.
The data will be analysed by latest version of the Software Platform for Statistical Analysis (SPSS). Descriptive statistic will be calculated for the numerical and categorical data. The normal distribution of the data and 95% confidence intervals will be calculated for the numerical and categorical data. Intervention and control group will be statistically compared, and differences will be measured at each time point. At the baseline will be ensure the similarity of intervention and control group for background variables. Cross-tabulations will be done for categorical and numerical variables. The sum variable of the measurements during the three different measurement time will be analysed using hierarchical linear mixed models will compare the changes over time between the groups.
Each participant will be informed before about the purpose of the study, issues related to research ethics, reporting of the findings and they will sign informed consent. Since the study involves research participants who are vulnerable due to cognitive impairment, researcher have clear protocol and special attention will be paid to ethical issues during the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFP intervention | Experimental | Behavioral: Person-First - Please (PFP)PFP 10 week continuing education intervention |
| Control arm | No intervention | –Usual care |
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses (RNs, Licensed Practice Nurses, Caregiver Assistants) who works in older people LTC. The inclusion criteria for nurses are that they work permanently or on a long-term deputy (at least 6 months) in units.
- The criteria for older people participating alone are that older people have enough cognitive capacity assessed by managers of the units. The criteria for next of kin participating is they will visit at least weekly in LTC.
Key exclusion criteria (2 listed)
- short- time deputy nurses
- older people in terminal care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-First - Please (PFP)PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher. | Behavioural | PFP intervention |
Primary outcome
Changes in nurses PCC competency
Time frame: baseline - after the intervention - 6 week follow up
The competence data will be collected by the Patient-centred Care Competency (PCC) scale as primary outcome. The PCC scale consists of 17 items with 5-point Likert scale (1 = minimal, 2 = below average, 3 = average, 4 = good, 5 = excellent), divided subscales: respecting patients' perspectives, promoting patient involvement in care processes, providing for patient comfort, and advocating for patients.
2 secondary outcomes
Changes in PCC climate in lens of nurses, older people and next of kin
Time frame: baseline - after the intervention - 6 week follow up
Evaluation of the continuing education named PFP in lens of the nurses
Time frame: during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 36918384Pakkonen M, Stolt M, Edvardsson D, Pasanen M, Suhonen R. Person-centred care competence and person-centred care climate described by nurses in older people's long-term care-A cross-sectional survey. Int J Older People Nurs. 2023 May;18(3):e12532. doi: 10.1111/opn.12532. Epub 2023 Mar 14.
- Individual participant dataSharing planned: No. small sample size and vulnerable participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhonen, Professor study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-First - Please (PFP) in people with Nurse-Patient Relations, run by Mari Pakkonen at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nurses PCC competency (time frame: baseline - after the intervention - 6 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.