Reliability of National Quality Indicator DataNIP-Q-UPGRADENCT06160024
Data Quality of National Quality Indicators in Long-term Care Facilities: a Validation and Evaluation Study
A study testing Program to improve data quality of national quality indicators in people with Reliability of National Quality Indicator Data, run by University of Basel at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reliability of National Quality Indicator Data
- What is being tested?
- Program to improve data quality of national quality indicators
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 14 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Institut für Pflegewissenschaft - Nursing Science (INS), University of Basel
Basel, Basel, 4056
Institut et Haute Ecole de la Santé La Source
Lausanne, Canton of Vaud, 1004
Scuola universitaria professionale della Svizzera italiana
Manno, Canton Ticino, 6928
About this 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)
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.
Read the 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.
- Being tested
- Program to improve data quality of national quality indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program to improve data quality of national quality indicatorsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Program to improve data quality of national quality indicators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start14 Oct 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reliability of National Quality Indicator DataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study addresses long-term care facilities
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Institut et Haute Ecole de la Santé la Source
- Responsible party
- Principal investigator, Franziska Zúñiga, University of Basel
- Investigators
- Franziska Zúñiga, Prof. Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160024
- Sponsor's protocol ID
- WP 1.4_1.9
- Acronym
- NIP-Q-UPGRADE
- Status last verified
- Feb 2026
- First submitted
- 12 Nov 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06160024
- Acronym / sponsor ID
- NIP-Q-UPGRADE / WP 1.4_1.9
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Institut et Haute Ecole de la Santé la Source
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study addresses long-term care facilities
| Arm | Type | Receives |
|---|---|---|
| Long-term care facilities | Other | Behavioral: Program to improve data quality of national quality indicatorsAll participating facilities will be offered the same bundle of measures, with core and optional or adaptable components based on the identified needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program to improve data quality of national quality indicatorsInterventions 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. | Behavioural | Long-term care facilities |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franziska Zúñiga, Prof. Dr. principal investigator
University of Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program to improve data quality of national quality indicators in people with Reliability of National Quality Indicator Data, run by University of Basel at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of agreement on the presence of malnutrition (time frame: up to 6 months at each time point). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.