NCT06160024

Brief Summary

This multiple-methods study with two data collection points (T0 and T1) aims to:

  1. 1.assess inter-rater reliability of the six national quality indicators in long-term care facilities (LTCFs) for older people in Switzerland (T0);
  2. 2.explore determinants of data quality of the national quality indicators (T0),
  3. 3.evaluate adoption and effectiveness of a bundle of measures to improve data quality of the national quality indicators (T1).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2023Dec 2026

Study Start

First participant enrolled

October 14, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

November 12, 2023

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (10)

  • Change in the rate of agreement on the presence of malnutrition

    Agreement on weight loss of 5% or more in the last 30 days or of 10% or more in the last 180 days per resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of self-reported pain

    Agreement on presence of daily moderate or higher pain intensity or with non-daily very strong pain intensity in the last 7 days per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of observed pain

    Agreement on presence of daily moderate or higher pain intensity or non-daily very strong pain intensity in the last 7 days per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of trunk fixation or seating that prevents the resident from rising

    Agreement on presence of daily fixation of the trunk or with seating that prevented the resident from rising in the last 7 days per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of bedrails

    Agreement on presence of daily use of bedrails or other devices on all open sides of the bed that did not allow the resident to leave the bed independently in the last 7 days per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of polypharmacy

    Agreement on presence of 9 or more active ingredients in the last 7 days per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the level of cognitive impairment

    Agreement on score on the Cognitive Performance Scale per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the presence of depression

    Agreement on score on the Depression Rating Scale per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Change in the rate of agreement on the assessment of life expectancy

    Agreement on life expectancy (six months or longer, less than six months or not clarified) per assessed resident between routine assessor and gold standard assessor. Primary effectiveness outcomes include all 6 quality indicators and 3 variables used for risk adjustment of quality indicators.

    up to 6 months at each time point

  • Primary implementation outcome: The rates of adoption of the intervention components of the program to improve the data quality of the national quality indicators

    The program with the intervention components will be defined after the first data collection period and will include training and supporting materials

    within 8 weeks

Study Arms (1)

Long-term care facilities

OTHER

All participating facilities will be offered the same bundle of measures, with core and optional or adaptable components based on the identified needs.

Behavioral: Program to improve data quality of national quality indicators

Interventions

Interventions will be developed based on the findings from the first data collection period. A bundle of interventions (Program to improve data quality of national quality indicators) will be offered to participating long-term care facilities to support changing behavior in data collection procedures via training and supporting material as implementation strategies with the goal to improve the data quality of the national quality indicators. The program will be tested in a separate pilot study. The second data collection period in the current study will be used to evaluate the effect of the implemented program.

Long-term care facilities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long-term care facilities:
  • have cantonal recognition as an inpatient long-term care facility
  • work with nationally recognized standardized assessment instruments (i.e., RAI-NH, BESA or Plaisir/Plex)
  • have at least 30 long-term residents
  • have at least two different internal staff members who are involved in the data collection for the national quality indicators
  • are willing to participate in two data collections (2023 and 2025) and in between to implement a implement a package of measures to optimise the reliability of the data for the national quality indicators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Basel, Basel, 4056, Switzerland

Location

Institut et Haute Ecole de la Santé La Source

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Scuola universitaria professionale della Svizzera italiana

Manno, Canton Ticino, 6928, 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
Principal Investigator

Study Record Dates

First Submitted

November 12, 2023

First Posted

December 7, 2023

Study Start

October 14, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations