NCT03471390

Brief Summary

This study aims to improve pain management in Swiss nursing homes by addressing behavior change of the care workers with a multilevel intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

March 7, 2018

Last Update Submit

April 27, 2021

Conditions

Keywords

Nursing Home

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

ProQuaS 2- Intervention

EXPERIMENTAL
Other: ProQuaS 2 Intervention

Interventions

Training and implementation of facility pain champions, comprehensive training of all care workers in pain assessment and management, implementation of pain management policies

ProQuaS 2- Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Senevita Obstgarten

Affoltern am Albis, Switzerland

Location

Senevita Gellertblick

Basel, Switzerland

Location

Senevita Wangenmatt

Bern, Switzerland

Location

Senevita Aespliz

Ittigen, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30109728BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Franziska Zúñiga, PhD

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: non- randomized incomplete stepped-wedge design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University lecturer

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 20, 2018

Study Start

October 24, 2017

Primary Completion

November 15, 2018

Study Completion

March 1, 2019

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations