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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03471390
Other study ID # ProQuaS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2017
Est. completion date March 1, 2019

Study information

Verified date April 2021
Source University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date March 1, 2019
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: 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 - 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 Exclusion Criteria: 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ProQuaS 2 Intervention
Training and implementation of facility pain champions, comprehensive training of all care workers in pain assessment and management, implementation of pain management policies

Locations

Country Name City State
Switzerland Senevita Obstgarten Affoltern Am Albis
Switzerland Senevita Gellertblick Basel
Switzerland Senevita Wangenmatt Bern
Switzerland Senevita Aespliz Ittigen

Sponsors (2)

Lead Sponsor Collaborator
University of Basel Senevita AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Brunkert T, Ruppen W, Simon M, Zúñiga 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Change from baseline to 6 months
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