The impact of regulation on the quality of care in nursing homes in Ireland: a time-series analysis of change in compliance

Introduction

In Ireland, as of the end of 2021, there were 567 registered nursing homes catering for approximately 31,842 older people¹. Quality of care is an essential component within nursing homes and has been at the forefront of the international policy agenda in recent years. This can be attributed to the changing expectations of what nursing homes should offer, an increase in the aging population, and high staff shortages and turnover². People who commission, buy, provide and receive care expect quality, not only in service, but also in the provision of care.

The concept of quality and quality of care is broad and its measurement complex, and health quality literature does not offer a precise and conclusive definition³. Many definitions emphasise the concept of the individual who is either receiving care or the assessor of quality interpreting quality from their perspective. For instance, in 1990, the American Institute of Medicine defined quality as the desired outcomes of the individual receiving care or the population at large. It is associated with the professional knowledge that was current at the time of assessment⁴. Similarly, Harteloh (2003) introduced the concept of the individual receiving care or the assessor of quality, interpreting quality from their perspective⁵. Other forms of thought focus on the concept of effectiveness and the importance of the organisations that deliver the care, for example, Campbell (2000) argued that quality lies in the ability of the person to access the health structures that provide the care and the effectiveness of that care⁶. In 2018, the World Health Organisation (WHO) broadly acknowledged quality to include each of these concepts and encompass ‘effectiveness, safety and person-centeredness’. Additionally, in order to appreciate the benefits from quality health care, services should be timely, equitable, integrated and efficient⁷.

The Donabedian model provides a framework to assess and evaluate quality of health care. According to the model, information about quality of care can be drawn from three components: “structure”, “process”, and “outcomes”⁸. Structure measures signify the characteristics of the setting and components include facilities, equipment, staffing, governance structure and audit. Process measures are defined by what is actually done in delivering and receiving care and includes resident and staff activities in care and diagnosis of care. Finally, outcome measures reflect the impact of care on a person’s health and well-being and covers areas such as resident knowledge, behaviour, satisfaction with care, feelings and beliefs, effectiveness and humanness⁹. This model states that the structure measures have an effect on process measures, which in turn affect outcome measures. According to Donabedian, outcome measures can be justified as the most important element to determine the effectiveness and quality of healthcare¹⁰.

Regulation is a process used for driving quality and improvement in care^11,12. It is often established in response to quality variability or as a result of failures or scandals^11–13. Regulation occurs where governments look to establish a set of norms or standards to target a certain level of quality. Organisations and individuals must then comply with regulations in order to meet the desired level of quality and avoid sanction. Sutherland and Leatherman (2006) describe regulation as providing direction to those being regulated, determining the level of compliance or performance required, and using regulatory powers to positively change the performance of those being regulated¹⁴. Morgan and Yeung (2007) described regulation in terms of regulatory interventions, enforcement, compliance, accountability and oversight. Using regulatory power, however, cannot guarantee standards of care are reached, regulation also depends on buy-in from services^{11,12,15–17}.

In Ireland, like in many other jurisdictions, residential care is regulated and this framework is enshrined in primary legislation: the Health Act, 2007¹⁸. Residential care for older people has been regulated by an independent public authority (referred to herein as the Regulator) since 2009. The Regulator monitors the quality of care and assesses compliance with the regulations, specifically the Health Act 2007 (Care and Welfare of Residents in Designated Centres for Older People) Regulations 2013¹⁹. This is achieved through monitoring inspections, which are routine inspections that assess the level of compliance with regulations and standards and monitor the quality of the service. The regulator determines and reports on the quality of care through its published inspection reports. Three compliance descriptors are used to describe the quality of a service: compliant, substantially compliant and not compliant.

Regulations are often used to improve care and the impacts of regulation on various aspects of care quality, in terms of structures, processes and outcomes⁹, have been studied extensively^20–24. Overall, the evidence reviewed shows that regulation can have positive impacts on quality of care. In terms of structures and processes, this related in particular to requirements on minimum direct care staffing (structures)^25–29, training and educational requirements^30–32, medication prescribing requirements³³, and requirements relating to restrictive practices (processes)³⁴. Requirements which related to outcomes focussed mostly on healthcare such as pressure ulcers, falls, emergency department visits, and hospitalisations, with little evidence focusing on requirements on residents’ rights, beliefs and satisfaction with care^35–38. In this sense, there is need for research that takes a resident-centred approach to exploring impacts of regulation on nursing homes. As such, the aim of this study is to examine nursing home compliance with regulations relating to outcomes, which include resident-centred outcomes, using data from the Regulator in Ireland, spanning a three year period.

Methods

Results

The 32 regulations for nursing homes from the Health Act, 2007 (Care and Welfare of Residents in Designated Centres for Older People) Regulations 2013 as amended⁴⁰ were mapped using the Donabedian quality framework and categorised under one of the following headings: “structure”, “process” or “outcome”⁹. A total of 44% (n=14) were determined to assess structure, 25% (n=8) were aligned with process, and 31% (n=10) were determined to align with outcome (Table 1).

Published inspection reports for years 2019 to 2021 included 1,153 inspection reports in total [2019: n=377, 2020: n=354, 2021: n=422]. The mean number of inspections undertaken each year was 384 (SD: 28). The mean number of assessed judgements of compliant for 2019, 2020 and 2021 was 164 (SD=49), 137 (SD=68) and 133 (SD=98) respectively; for substantially compliant the mean number of assessed judgements was 36 (SD=27) in 2019, 31 (SD=21) in 2020, and 36 (SD=35), and for non-compliant it was 25 (SD=19) in 2019, 18 (SD=18) in 2020, and 13 (SD=14) in 2021.

Ten of the 32 regulations were mapped to “outcomes” and were brought forward for analysis. The most frequently assessed of the “outcomes” regulations was ‘Regulation 9: Residents rights’. This was assessed 1,030 times (in 89% of inspections) during the three years. The least frequently inspected regulation ‘Regulation 10: Communication’ was assessed 150 times (in 13% of inspections) during the three years (Table 2).

Three regulations were evaluated as “compliant” in 90% or more of inspections, consistently over the three years (range: 90% to 96%). These regulations were ‘Regulation 10: Communication difficulties’, ‘Regulation 11: Visits’ and ‘Regulation 20: Information for residents’. ‘Regulation 9: Residents rights’ had the lowest percentage “compliant” over the three years combined (mean=54%, SD=3.7); 50% (n=162) in 2019, 59% (n=192) in 2020 and 54% (n=210) in 2021. Only ‘Regulation 29: Medicines and pharmaceutical services’ had a lower level of compliance in 2021 at 53% compliance.

A significant improvement in the level of compliance and reduction in non-compliance was found in two of the ten regulations over the three years: ‘Regulation 9: Residents' rights’ (p=0.001) and ‘Regulation 11: Visits’ (p=0.001). A significant change was not observed for ‘Regulation 7: Managing behaviour that is challenging’, and ‘Regulation 8: Protection’, however, there was a gradual year-on-year increase in compliance from 2019 to 2021, increasing from 63% (n=177) to 69% (n=148) and from 81% (n=246) to 86% (n=170) respectively.

Compliance with ‘Regulation 12: Personal possessions’ decreased over the three years, however there was also a concomitant decrease in non-compliance (p=0.003). A non-significant trend in reduction of year-on-year compliance was observed for three regulations: ‘Regulation 12: Personal possessions’ reduced from 74% (n=153) in 2019 to 58% (n=53) in 2021 (p=0.003); ‘Regulation 18: Food and nutrition’ which reduced from 83% (n=185) in 2019 to 76% (n=64) in 2021; and ‘Regulation 20: Information for residents’ reduced from 93% (n=110) in 2019 to 91% (n=20) in 2021. However, for these three regulations, only ‘Regulation 20: Information for residents’ had an increase in non-compliance during the same time.

Discussion

This study examined the legislation used for regulating nursing homes and mapped these regulations according to the Donabedian framework⁹ of structure, process, and outcome. The results found less than a third of regulations were outcome focussed and therefore determined as quality-related regulations, with the majority of regulations centering on structure or process. Donabedian’s determined outcomes to be the ‘ultimate validators’ of the effectiveness and quality of care¹⁰, therefore within our current regulatory framework, the focus on quality could be overlooked in favour of assessment of structure or processes.

The study aimed to examine the relationship between regulation and compliance with quality-related regulations. There was significant improvement in compliance with two regulation (‘Regulation 9: Residents rights’ and ‘Regulation 11: Visits’). Most other regulations examined trended upwards without reaching significance however one regulation, ‘Regulation 12: Personal possession’, decreased in compliance over the three years.

Overall, the results demonstrate that regulation can be a positive influence on quality maintenance and improvement. This supports the findings of Bravo et al. (2014)⁴¹ and Ostaszkiewicz et al. (2006) which found that improvements in quality cannot be definitively linked to regulation but it is highly likely that regulation was a driver for improvements⁴².

A key result of this study was nursing homes’ low rate of compliance (≤60%) with residents’ rights (Regulation 9) although a significant improvement in compliance across the 3 years was observed. Residents’ rights was the most frequently inspected quality-related regulation, thus demonstrating it is a key focus for inspectors. Such findings were consistent with Donnelly and O’Keffee (2021) who identified that many people living in residential care have their rights impacted. This included not being free to leave their health or social care residence due to a lack or perceived lack of capacity to make their own decisions, or due to it being determined as not safe for them to do so⁴³. In 2021, advocacy groups in Ireland issued a joint statement calling on the Irish Government to introduce a suite of measures, including rights-based inspections; such measures would support the safety, dignity and rights of older people in nursing homes⁴⁴.

Although not significant, the assessment of protection (Regulation 8) showed a gradual year year-on-year improvement in compliance rates. Such improvement could be attributed to the increased focus on this regulation over the three years, a potential result of recent policy and legislative developments in Ireland. Such developments include the implementation of the Assisted Decision-Making Capacity Act (2015)⁴⁵, the long anticipated ratification of the United Nations Convention on the Rights of Persons with Disabilities (UNCPRD)⁴⁶, and advancement of the Adult Safeguarding Bill 2017⁴⁷. The trend of improving compliance with protection underlines the importance of regulation in ensuring safer practices in place to protect vulnerable residents.

Similar to protection, Regulation 7 which assessed positive behaviour support, also showed a gradual year-on-year increase in compliance. The increasing trend toward compliance is a positive finding especially considering how the Regulator aligns positive behaviour support with the rights of residents⁴⁸. It is also determined to have a significant impact on the well-being of the resident and those around them. Horner (2000) explains positive behaviour supports as the thinking and re-organisations of a person-environment to help alleviate behaviours to improve a person’s quality of life⁴⁹. Anderson and Freeman (2000) suggest that positive behaviour support has had the greatest impact on the quality of service for people with behaviour that is challenging⁵⁰.

The assessment of visitations (Regulation 11) to nursing home residents showed a high rate of compliance during the three years with a significant gradual year-on-year improvement. These findings are unexpected in light of the COVID-19 restrictions which were in place in nursing homes during this time. It is surprising however that this regulation was not inspected more frequently considering visitation were curtailed during this time; an extremely unusual occurrence and contrary to the normal operations of residential care⁵¹. Prohibiting visiting in nursing homes has been linked with social isolation and increased risk of depression, and despair and intensify dementia in older adults⁵². In 2022, a submission was made to the Irish Human Rights and Equality Commission (IHREC) regarding the need for a human rights-based public inquiry into the experiences of people in residential care and their relatives and staff carers during the Covid-19 pandemic. This submission highlights the concerns communicated to the Regulator and other public bodies regarding the impact of visiting prohibitions, communication vacuums and safeguarding spaces on people’s treatment in nursing homes⁵³.

Strengths and limitations

As far as we are aware, this was the first study to be conducted to explore compliance with regulations in nursing homes from an impact on quality improvement perspective. As such, this study extends our knowledge on what is currently an under-researched area. The study made use of national level data that are wholly inclusive of all registered nursing homes in Ireland. In addition, the three year sampling strategy aligns with the regulators’ protocol of at least one inspection of each nursing homes every three years, thus, all nursing homes in Ireland are represented in the analysis. However, using a three year period somewhat limits the amount of time available for observing change. That said, a three year period was considered appropriate as care provision in nursing homes is an ever changing environment and a wider study period would risk higher confounding by care practice change, change in nursing homes ownership, national economic changes and other.

In other limitations, the data used in the study were collected for regulatory purposes and as such our analysis constitutes secondary data analysis. As with all secondary analyses, this limits the analysis that can be conducted; however, the research question was designed in the knowledge of the available data and its format. The regulations categorised as “outcome” under Donabedian’s framework for quality⁹ were not assessed at every inspection thus prohibiting direct comparisons and analysis of change in individual nursing homes. Despite this, assessment of change at a national level was possible with the data.

Furthermore, we cannot directly attribute the change in compliance to the phenomenon of regulation and inspection as other quality improvements could have been ongoing at service level during the time period of this study. However, the use of a national database, large sample and three years of data means that any impact of local interventions would not explain change in the national mean.

Recommendations

In relation to policy, no substantive changes have been made to the regulations for nursing homes since 2013. This was contrary to the literature which was emphatic on the need to regularly review and update regulations to ensure that they remain valid, effective, and deliver on their intended purpose^54–57. Such a failure to review and update the regulations could have significant implications for the society it hopes to protect. Furthermore, since the regulations were introduced, there have been a number of events, policy and legislative changes which have changed the landscape of social care in Ireland namely the COVID-19 pandemic, the implementation of the Assisted Decision-Making Capacity Act (2015)⁴⁵, ratification of the UNCPRD⁴⁶, introduction of the Adult Safeguarding Bill 2017⁴⁷, and finally the launching of Sláintecare - the Government’s framework for the future of health and social care^58,59. In particular, the COVID-19 pandemic illustrated how the regulatory framework for nursing homes in Ireland was not robust enough to mitigate the negative impact on residents^58–60. It is therefore recommended that the regulations in place for nursing homes be reviewed as a matter of urgency, informed by evidence and consultation with key stakeholders. The reviewed regulation should also be underpinned by the components of quality. Finally we propose there to be a Governmental policy for the ongoing review of regulations for social care.

In terms of practice, we recommend for regulators to make greater connections between regulation and quality, and report on this so people can understand their interdependence. Therefore a natural progression of this work is to conduct further investigation of what is important to residents and how this can be incorporated and reported upon inspection reports. This could include a review of how inspectors illicit the views of residents on quality, and other methods of garnering residents’ views should be explored such as focus groups and questionnaires. Furthermore, there needs to be greater transparency in how data for the residents section of the inspection report is gathered including how many residents were spoken with (sample size) and if tools such as questionnaires or interview scripts were used.

Conclusion

Of the 32 regulations for nursing homes in Ireland, ten were outcomes focused and the larger proportion focused on the structure of the nursing homes and the process of care delivery. There was a trend of increasing levels of compliance and reduction of non-compliance for the majority of these regulations, however there were areas for improvement such as the low rate of compliance with residents’ rights and the decrease in compliance of personal possessions. Findings from this study have implications for policy, regulatory practice, and further research.