Improving Pain Management in Nursing Homes: a Pilot Study (ProQuaS)

April 27, 2021 updated by: Franziska Zúñiga, University of Basel

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Affoltern Am Albis, Switzerland
        • Senevita Obstgarten
      • Basel, Switzerland
        • Senevita Gellertblick
      • Bern, Switzerland
        • Senevita Wangenmatt
      • Ittigen, Switzerland
        • Senevita Aespliz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProQuaS 2- 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Collaborators

Senevita AG

Investigators

  • Principal Investigator: Franziska Zúñiga, PhD, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

November 15, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ProQuaS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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