Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: The case of internal audits

BACKGROUND Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study aims to contribute to the knowledge on how to increase compliance with obligatory rules and regulations. METHODS The internal audit system (the 'tracer system') of a large Dutch academic hospital is used as a case to investigate different implementation approaches and their effect on compliance. This case allowed us to use a multi-actor and multi-method approach for data collection. Internal audits (N = 16) were observed, audit reports were analyzed, and semi-structured interviews were conducted with both the internal auditors (N = 23) and the ward leaders (N = 14) responsible for compliance. Framework analysis was used to analyze the data. RESULTS Although all auditors use catalytic enforcement actions, these do not lead to (intended) compliance of all ward leaders. Rather, the catalytic actions contribute to (intended) compliance of ward leaders that are motivated, whereas they do not for the ward leaders that are not motivated. For the motivated ward leaders, catalytic enforcement actions contribute to (intended) compliance by increasing ward leaders' knowledge of the rules and how to comply with them. CONCLUSIONS Our findings suggest that the effectiveness of implementation actions depends not only on the actions themselves, but also on the pre-existing motivation to comply. These findings imply that there is not one 'best' approach to the implementation of obligatory rules. Rather, the most effective approach depends on the willingness to comply with rules and regulations

Using regulatory enforcement theory to explain compliance with quality and patient safety regulations : The case of internal audits

Background: Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study aims to contribute to the knowledge on how to increase compliance with obligatory rules and regulations. Methods: The internal audit system (the 'tracer system') of a large Dutch academic hospital is used as a case to investigate different implementation approaches and their effect on compliance. This case allowed us to use a multi-actor and multi-method approach for data collection. Internal audits (N = 16) were observed, audit reports were analyzed, and semi-structured interviews were conducted with both the internal auditors (N = 23) and the ward leaders (N = 14) responsible for compliance. Framework analysis was used to analyze the data. Results: Although all auditors use catalytic enforcement actions, these do not lead to (intended) compliance of all ward leaders. Rather, the catalytic actions contribute to (intended) compliance of ward leaders that are motivated, whereas they do not for the ward leaders that are not motivated. For the motivated ward leaders, catalytic enforcement actions contribute to (intended) compliance by increasing ward leaders' knowledge of the rules and how to comply with them. Conclusions: Our findings suggest that the effectiveness of implementation actions depends not only on the actions themselves, but also on the pre-existing motivation to comply. These findings imply that there is not one 'best' approach to the implementation of obligatory rules. Rather, the most effective approach depends on the willingness to comply with rules and regulations

Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: The case of internal audits

BACKGROUND Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study aims to contribute to the knowledge on how to increase compliance with obligatory rules and regulations. METHODS The internal audit system (the 'tracer system') of a large Dutch academic hospital is used as a case to investigate different implementation approaches and their effect on compliance. This case allowed us to use a multi-actor and multi-method approach for data collection. Internal audits (N = 16) were observed, audit reports were analyzed, and semi-structured interviews were conducted with both the internal auditors (N = 23) and the ward leaders (N = 14) responsible for compliance. Framework analysis was used to analyze the data. RESULTS Although all auditors use catalytic enforcement actions, these do not lead to (intended) compliance of all ward leaders. Rather, the catalytic actions contribute to (intended) compliance of ward leaders that are motivated, whereas they do not for the ward leaders that are not motivated. For the motivated ward leaders, catalytic enforcement actions contribute to (intended) compliance by increasing ward leaders' knowledge of the rules and how to comply with them. CONCLUSIONS Our findings suggest that the effectiveness of implementation actions depends not only on the actions themselves, but also on the pre-existing motivation to comply. These findings imply that there is not one 'best' approach to the implementation of obligatory rules. Rather, the most effective approach depends on the willingness to comply with rules and regulations

Why Medical Residents Do (and Don’t) Speak Up About Organizational Barriers and Opportunities to Improve the Quality of Care

Purpose Medical residents are valuable sources of information about the quality of frontline service delivery, but if they do not speak up, their ideas, opinions, and suggestions for improving their work practices cannot be considered. However, speaking up can be difficult for residents. Therefore, the authors have explored both what helps residents speak up about organizational barriers and opportunities to improve the quality of their work and what hinders them from doing so. Method The authors conducted an exploratory qualitative interview study with 27 Dutch medical residents in the Netherlands in 2016. They used the critical incident technique for data collection and the constant comparison method of the Qualitative Analysis Guide of Leuven for data analysis. Results Three types of incidents in which residents considered speaking up are described. The authors identified 2 main considerations that influenced residents’ decisions about speaking up: Is it safe to speak up, and is speaking up likely to be effective? Residents’ decisions were influenced by personal, team, and organizational aspects of their situations, such as supervisors’ open attitudes, hierarchy, duration of clinical rotations, organization size, and experiences (either vicarious or their own). Conclusions Findings from this study indicate that residents tend to be silent when they encounter organizational barriers or opportunities to improve the quality of their work. Perceived effectiveness and safety are important forces that drive and constrain speaking up. The authors provide important starting points to empower medical residents to speak up about their suggestions for change

Limited patient adherence to highly active antiretroviral therapy for HIV-1 infection in an observational cohort study

Background: Adherence to highly active antiretroviral therapy (HAART) for human immunodeficiency syndrome type 1 (HIV-1) infection is essential to sustain viral suppression and prevent drug resistance. We investigated adherence to HAART among patients in a clinical cohort study. Methods: Patients receiving HAART had their plasma concentrations of protease inhibitors or nevirapine measured and completed a questionnaire on adherence. We determined the percentage of patients who reported taking all antiretroviral medication on time and according to dietary instructions in the past week. Drug exposure was compared between patients reporting deviation from their regimen and fully adherent patients. Among patients who received HAART for at least 24 weeks, we assessed the association between adherence and virologic outcome. Results: A total of 224 of 261 eligible patients completed a questionnaire. Forty-seven percent reported taking all antiretroviral medication on time and according to dietary instructions. Patients who reported deviation from their regimen showed lower drug exposure compared with fully adherent patients (median concentration ratio, 0.81 vs 1.07; P=.001). Among those receiving HAART for at least 24 weeks, patients reporting deviation from their regimen were less likely to have plasma HIV-1 RNA levels below 500 copies/mI. (adjusted odds ratio, 4.0; 95% confidence interval, 1.4-11.6) compared with fully adherent patients. Conclusions: Only half of the patients took all antiretroviral medication in accordance with time and dietary instructions in the preceding week. Deviation from the antiretroviral regimen was associated with decreased drug exposure and a decreased likelihood of having suppressed plasma HIV-1 RNA loads. Patient adherence should remain a prime concern in the management of HIV-1 infection