NCT06848725

Brief Summary

Since 2019, long-term care facilities in Switzerland are obliged by the Federal Insurance Law (KVG, Art. 59a) to report data for the calculation and public reporting of medical quality indicators (MQI). By 2024, this is done in four clinical domains: polypharmacy, pain, malnutrition and the use of physical restraints. This data is used for both monitoring quality of care on a national level and for internal quality of care development. To be valid and reliable, MQI data needs to be collected according to specified measurement instructions. An ethnographic study conducted within the NIP-Q-UPGRADE identified numerous challenges, which can lead to poor data quality. The overall aim of this pilot study is to test the implementation of a data quality development toolkit concerning the MQI. The toolkit uses a train-the-trainer strategy. The research team will prepare external training providers to train delegated staff from the long-term care facilities (further called champions), who will then train and support their co-workers to collect reliable MQI data. The research team developed training and support materials and organized an e-mail contact centre for MQI related questions for the participating facilities. Implementation outcomes will be assessed at two levels: long-term care facilities and the external training providers. Objectives at the external training provider level:

  1. 1.To determine the acceptability and feasibility of the training and support materials.
  2. 2.To determine the fidelity to the training and adaptations made when implementing it.
  3. 3.To identify the barriers and facilitators for the implementation of the training.
  4. 4.To measure the costs associated with delivering the training.
  5. 5.To determine the acceptability and the feasibility of the data quality development toolkit components.
  6. 6.To determine the fidelity to toolkit components and adaptations made when implementing it.
  7. 7.To identify the barriers and facilitators for the implementation of the toolkit.
  8. 8.To measure the costs associated with implementing the toolkit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 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

December 5, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

January 3, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

NIP-Q-UPGRADEquality indicatorslong-term caredata quality improvement

Outcome Measures

Primary Outcomes (6)

  • Acceptability of the toolbox

    Acceptability of toolbox components will be assessed in a survey with Acceptability of Intervention Measure (AIM), a 4-item instrument measuring the acceptability of an intervention. Further exploration of acceptability in qualitative interviews and focus groups

    After each champion's training unit (baseline, 3 weeks and 9 weeks): interview with trainer. At 3 months: survey and focus groups with champions, leadership, nursing and care staff. At 6 months: focus group with champions.

  • Feasibility of the toolbox

    Feasibility of toolbox components will be assessed in a survey with Feasibility of Intervention Measure (FIM), a 4-item instrument measuring the feasibility of an intervention. Further exploration of feasibility in qualitative interviews and focus groups.

    After each champion's training unit (baseline, 3 weeks and 9 weeks): interview with trainer. At 3 months: survey and focus groups with champions, leadership, nursing and care staff. At 6 months: focus group with champions.

  • Implementation fidelity

    Degree of fidelity to each component (yes, partial, no) will be measured using a questionnaire survey. Further exploration of implementation fidelity in qualitative interviews and focus groups.

    After each champion's training unit (baseline, 3 weeks and 9 weeks): interview with trainer. At 3 months: survey and focus groups with champions, leadership, nursing and care staff. At 6 months: focus group with champions.

  • Barriers to the implementation of the toolbox

    Barriers to the implementation will be explored in qualitative interviews and focus groups, and categorized according to the Consolidated Framework of Implementation Research (CFIR)

    After each champion's training unit (baseline, 3 weeks and 9 weeks): interview with trainer. At 3 months: focus groups with champions, leadership, nursing and care staff. At 6 months: focus group with champions.

  • Facilitators to the implementation of the toolbox

    Facilitators to the implementation will be explored in qualitative interviews and focus groups, and categorized according to the Consolidated Framework of Implementation Research (CFIR)

    At 3 months: focus groups with champions, leadership, nursing and care staff. At 6 months: focus group with champions.

  • Sum of costs associated with implementation of the toolkit in Swiss francs

    Costs will be calculated based on time spent on implementation activities per staff group with corresponding hourly salary estimate, recorded in an activity logbook

    Continuously from baseline training to 3 months after

Study Arms (1)

Long-term care facilities

EXPERIMENTAL

All participating facilities will be offered the same toolbox

Behavioral: Data quality development toolkit concerning the medical quality indicators (MQI)

Interventions

The toolkit uses a train-the-trainer strategy. The research team will: * develop training and support materials for external training providers and delegated staff (champions) from the long-term care facilities * prepare external training providers within a one 3h session to train champions from the long-term care facilities * organize an e-mail contact centre for MQI related questions for the participating facilities. The external training providers will: \- train the champions in one full day (8h) in-person training session and in 2 online sessions a 4h and 2h to support their co-workers to collect reliable MQI data. Based on the received training, the champions will: * provide internal trainings to the care and nursing team, * perform data quality monitoring, * provide feedback on data quality and act as a contact person for questions on MQI in their facility.

Long-term care facilities

Eligibility Criteria

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

You may qualify if:

  • External training providers:
  • willing to implement trainings as designed by the research team and to all interested long-term care facilities
  • have capacity to provide the trainers and infrastructure for the trainings - agree to non-commercial use of training materials
  • Trainer:
  • with competence in training staff of long-term care facilities
  • with knowledge on data collection of the current MQIs
  • Long-term care facilities:
  • with a cantonal recognition as a residential long-term care facility
  • willing to implement the toolkit
  • which can nominate at least one champion
  • Champions:
  • Long-term care facility employees motivated to take up the role
  • having sufficient knowledge of the residents, infrastructure and processes in the facility (e.g., resident care, needs assessment instrument, electronic health records)
  • Ideally with experience in leadership, staff training, MQI data collection and quality monitoring, e.g., nurse, nurse expert, quality manager, needs assessment instrument manager
  • Management and staff responsible for quality:
  • +5 more criteria

You may not qualify if:

  • \. long-term care facilities that are participants of the study "Data Quality and National Quality Indicators in Long-term Care Facilities: a Validation Study and Evaluation Study"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland.

Manno, Canton Ticino, 6928, Switzerland

Location

Institut für Pflegewissenschaft - Nursing Science (INS), University of Basel

Basel, 4056, Switzerland

Location

La Source School of Nursing, HES-SO University of Applied Sciences and Arts of Western Switzerland, Lausanne, Switzerland

Lausanne, Switzerland

Location

Study Officials

  • Franziska Zúñiga, Prof. Dr.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study addresses long-term care facilities
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Franziska Zúñiga

Study Record Dates

First Submitted

January 3, 2025

First Posted

February 27, 2025

Study Start

December 5, 2024

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

February 25, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations