- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06160024
Data Quality of National Quality Indicators in Long-term Care Facilities: a Validation and Evaluation Study (NIP-Q-UPGRADE)
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)
This multiple-methods study with two data collection points (T0 and T1) aims to:
- assess inter-rater reliability of the six national quality indicators in long-term care facilities (LTCFs) for older people in Switzerland (T0);
- explore determinants of data quality of the national quality indicators (T0),
- 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.
Study Overview
Status
Intervention / Treatment
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:
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.
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.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basel
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Basel, Basel, Switzerland, 4056
- Institut für Pflegewissenschaft - Nursing Science (INS), University of Basel
-
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Canton Ticino
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Manno, Canton Ticino, Switzerland, 6928
- Scuola universitaria professionale della Svizzera italiana
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Canton of Vaud
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Lausanne, Canton of Vaud, Switzerland, 1004
- Institut et Haute Ecole de la Santé La Source
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Long-term care facilities
All participating facilities will be offered the same bundle of measures, with core and optional or adaptable components based on the identified needs.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the rate of agreement on the presence of malnutrition
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: up to 6 months at each time point
|
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
Time Frame: within 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Franziska Zúñiga, Prof. Dr., University of Basel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WP 1.4_1.9
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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