Pain ManagementProQuaSNCT03471390
Improving Pain Management in Nursing Homes: a Pilot Study
A study testing ProQuaS 2 Intervention in people with Pain Management, run by University of Basel at 4 sites in Switzerland.
Trial summary
This study aims to improve pain management in Swiss nursing homes by addressing behavior change of the care workers with a multilevel intervention Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- ProQuaS 2 Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 24 Oct 2017to 1 Mar 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Care workers:
- Registered nurses, licensed practical nurses/certified caregivers, nursing assistants, nurse aides and other care workers from the participating nursing home
- Working in direct resident care
- Participating care workers have to be employed for at least one month at the data collection
- Students, apprentices and interns have to be employed at least six months in total
- Speak and understand German
Show all 10Show fewer
- Older than 16 years
- Residents:
- All residents living in a participating nursing home, older than 64 years
- Written informed consent to participate in data collection signed by the resident or in case of severe cognitive impairment by his/her legally acceptable representative
Who cannot join
- Care workers:
- Temporary employment for less than six months
- Residents:
- Critical current health status or terminal life situation
- Known life expectancy less than 3 months
- Short term residents (length of stay <6 months)
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Senevita Obstgarten
Affoltern am Albis
Senevita Gellertblick
Basel
Senevita Wangenmatt
Bern
Senevita Aespliz
Ittigen
About this study
Official title: Identification and Development of Interfaces and Processes to Improve Quality of Life of Residents at Senevita ProQuaS 2- Improving Pain Management in Nursing Homes: a Pilot Study
This study aims to improve pain management in Swiss nursing homes by addressing behavior change of the care workers with a multilevel intervention
Read the detailed description
Pain management in nursing homes often is inadequate despite the availability of evidence- based pain management guidelines. Barriers to pain management in nursing homes occur on several levels including lack of knowledge and negative beliefs towards pain of care workers.
For this embedded mixed-methods pilot study a convenience sample of maximum six nursing homes will be recruited. The planned intervention comprises the implementation of pain management policies, training of all care workers in pain assessment and management as well as training and introduction of a facility pain champion. Quantitative outcomes assessed at baseline, after three and six months include self-efficacy and attitudes to pain of care workers, functional interference from pain and pain intensity in residents. Feasibility and acceptability of the intervention and potential barriers to its implementation will be explored in focus groups and interviews.
- Conditions
- Pain Management
- Being tested
- ProQuaS 2 Intervention
- Keywords
- Nursing Home
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProQuaS 2 InterventionOther
Training and implementation of facility pain champions, comprehensive training of all care workers in pain assessment and management, implementation of pain management policies
| Study group | Role | What they receive |
|---|---|---|
| ProQuaS 2- Intervention | Experimental | Not described Receives: Other: ProQuaS 2 Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self- efficacy in pain management
Care workers' self-efficacy in pain management scale
- investigator-developed scale based on guide for constructing self-efficacy scales (Bandura 2006)
- numeric rating scale ranging from 0 ="not confident at all" to 100="highly confident"
- total score will be computed by calculating a mean over single item scores (range: 0-100, higher scores indicating better self-efficacy)
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start24 Oct 2017
- Primary completion15 Nov 2018
- Study completion1 Mar 2019
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 Pain ManagementStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- non- randomized incomplete stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Senevita AG
- Responsible party
- Principal investigator, Franziska Zúñiga, University of Basel
- Investigators
- Franziska Zúñiga, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471390
- Sponsor's protocol ID
- ProQuaS
- Acronym
- ProQuaS
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunkert T, Ruppen W, Simon M, Zuniga F. A theory-based hybrid II implementation intervention to improve pain management in Swiss nursing homes: A mixed-methods study protocol. J Adv Nurs. 2019 Feb;75(2):432-442. doi: 10.1111/jan.13817. Epub 2018 Sep 6.
PubMed 30109728
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Development of Interfaces and Processes to Improve Quality of Life of Residents at Senevita ProQuaS 2- Improving Pain Management in Nursing Homes: a Pilot Study
- ClinicalTrials.gov ID
- NCT03471390
- Acronym / sponsor ID
- ProQuaS / ProQuaS
- Conditions
- Pain Management
- Keywords
- Nursing Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Senevita AG
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Mar 2018 (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.
This study aims to improve pain management in Swiss nursing homes by addressing behavior change of the care workers with a multilevel intervention
Detailed description
Pain management in nursing homes often is inadequate despite the availability of evidence- based pain management guidelines. Barriers to pain management in nursing homes occur on several levels including lack of knowledge and negative beliefs towards pain of care workers.
For this embedded mixed-methods pilot study a convenience sample of maximum six nursing homes will be recruited. The planned intervention comprises the implementation of pain management policies, training of all care workers in pain assessment and management as well as training and introduction of a facility pain champion. Quantitative outcomes assessed at baseline, after three and six months include self-efficacy and attitudes to pain of care workers, functional interference from pain and pain intensity in residents. Feasibility and acceptability of the intervention and potential barriers to its implementation will be explored in focus groups and interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non- randomized incomplete stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| ProQuaS 2- Intervention | Experimental | Other: ProQuaS 2 Intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Registered nurses, licensed practical nurses/certified caregivers, nursing assistants, nurse aides and other care workers from the participating nursing home
- Working in direct resident care
- Participating care workers have to be employed for at least one month at the data collection
- Students, apprentices and interns have to be employed at least six months in total
- Speak and understand German
Key exclusion criteria (6 listed)
- Temporary employment for less than six months
- Critical current health status or terminal life situation
- Known life expectancy less than 3 months
- Short term residents (length of stay <6 months)
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 |
|---|---|---|
| ProQuaS 2 InterventionTraining and implementation of facility pain champions, comprehensive training of all care workers in pain assessment and management, implementation of pain management policies | Other | ProQuaS 2- Intervention |
Primary outcome
Self- efficacy in pain management
Time frame: Change from baseline to 6 months
Care workers' self-efficacy in pain management scale * investigator-developed scale based on guide for constructing self-efficacy scales (Bandura 2006) * numeric rating scale ranging from 0 ="not confident at all" to 100="highly confident" * total score will be computed by calculating a mean over single item scores (range: 0-100, higher scores indicating better self-efficacy)
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 30 Apr 2021.
- Background: PubMed 30109728Brunkert T, Ruppen W, Simon M, Zuniga F. A theory-based hybrid II implementation intervention to improve pain management in Swiss nursing homes: A mixed-methods study protocol. J Adv Nurs. 2019 Feb;75(2):432-442. doi: 10.1111/jan.13817. Epub 2018 Sep 6.
- Individual participant dataSharing planned: No
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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.
Franziska Zúñiga, PhD principal investigator
University of Basel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProQuaS 2 Intervention in people with Pain Management, run by University of Basel at 4 sites in Switzerland.
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 10 inclusion and 6 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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?
Self- efficacy in pain management (time frame: Change from baseline to 6 months). 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 NCT03471390, 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 30 Apr 2021.