Clinical trial NCT06160024: Data Quality of National Quality Indicators in Long-term Care Facilities: a Validation and Evaluation Study
Official title: Data Quality of National Quality Indicators in Long-term Care Facilities: a Validation and Evaluation Study (NIP-Q-UPGRADE Sub-aim 1.4 and 1.9)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Reliability of National Quality Indicator Data
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences and Arts of Southern Switzerland
name: Institut et Haute Ecole de la Santé la Source
First posted: 2023-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study addresses long-term care facilities
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

The study will take place in three language regions of Switzerland. The intended sample is 30 LTCFs . The current reliability of the national quality indicator data will be assessed by comparing two independent quality indicator assessments for the same 30 residents per facility. Afterwards a focus group discussion will be conducted in each facility to explore determinants (barriers and facilitators) to data collection of the national quality indicators. Findings from the first data collection period will be used to develop a program with a bundle of measures (interventions and implementation strategies) to improve data quality of the national quality indicators. The program will be piloted in a separate study and then implemented in the LTCFs, which took part in the initial data collection. The second data collection period will start 3 months after the implementation of the program. A survey of healthcare and management staff will be conducted to assess implementation outcomes. A second reliability assessment of the quality indicators will be conducted with the same procedures to evaluate the effectiveness of the implemented measures.

Detailed description: This multicentre study uses a multi-method approach to assess current data quality of the national quality indicators in Swiss LTCFs and to evaluate a program with a bundle of measures designed to improve data quality of these quality indicators. The study aims to recruit a convenience sample of 30 LTCFs in three language regions (18 German speaking, 9 French speaking and 3 Italian speaking).

The study will use 2 data collection time points, T0 in 2023 and T1 in 2025. Between the two data collections a program with bundle of measures to improve the data quality of the national quality indicators data will be developed and implemented in the participating facilities. The study will use the following procedures:

1. Assessment of the reliability of the national quality indicators data in LTCFs:

   For each participating facility, a double collection of the quality indicators data will be carried out for 30 consecutive assessments of residents over a period of up to 6 months (duration depends on the size of the LTCF, each resident has a needs assessment at least every 180 days, during which quality indicator data are assessed routinely). One professional from each LTCF will be specifically trained in data collection by the research team and will carry out gold standard assessments. Other nursing staff members will conduct the assessments as part of the usual care process. The trained assessor will conduct the assessments of the quality indicators for the same residents in the same assessment period independently, whenever possible based on the electronic health record of the resident, in case of self-reported pain residents may be asked directly, if the data is not recorded daily with a protocol. The data will be entered in a secure online electronic data collection platform (REDCap). An administrative staff member will extract data from routine assessments to enter it in REDCap and the trained assessor will register the gold standard assessment him-/herself. Monthly online monitoring meetings will be conducted with the trained assessors to discuss any difficulties in the assessments and ensure adherence to study procedures.
2. Exploration of the determinants of data quality:

   A focus group discussion with 4-6 staff members involved in organising and conducting the data collection or quality assurance of the quality indicators data i.e., registered nurses or licensed practical nurses, quality managers, will be conducted in each facility after the data collection to assess data reliability is finished. Observed problems concerning data reliability will be discussed to elicit possible sources of errors as well as factors facilitating or hindering correct data collection. The focus group will last around 1h.
3. Evaluation of adoption and effectiveness of a bundle of measures to improve the national quality indicator data will be collected starting three months after implementation of the developed measures.

An online survey of LTCF staff members will be conducted to assess adoption of the intervention components. Eligible to participate will be all facility staff members who were involved in or affected by the introduced data quality improvement measures. To assess effectiveness, inter-rater reliability assessment will be performed in the same way as in aim 1. Effectiveness is defined as an improvement in inter-rater reliability.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in the rate of agreement on the presence of malnutrition
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of self-reported pain
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of observed pain
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of trunk fixation or seating that prevents the resident from rising
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of bedrails
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of polypharmacy
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the level of cognitive impairment
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the presence of depression
timeFrame: up to 6 months at each time point
measure: Change in the rate of agreement on the assessment of life expectancy
timeFrame: up to 6 months at each time point
measure: Primary implementation outcome: The rates of adoption of the intervention components of the program to improve the data quality of the national quality indicators
timeFrame: within 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manno
country: Switzerland
facility: Scuola universitaria professionale della Svizzera italiana
state: Tessin
city: Lausanne
country: Switzerland
facility: Institut et Haute Ecole de la Santé La Source
state: Waadt
city: Basel
country: Switzerland
facility: Institut für Pflegewissenschaft - Nursing Science (INS), University of Basel
Study officials:
affiliation: University of Basel
name: Franziska Zúñiga, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: