Factors facilitating the implementation of a clinical decision support system in primary care practices: a fuzzy set qualitative comparative analysis.

BACKGROUND: Understanding how to implement innovations in primary care practices is key to improve primary health care. Aiming to contribute to this understanding, we investigate the implementation of a clinical decision support system (CDSS) as part of the innovation fund project AdAM (01NVF16006). Originating from complexity theory, the practice change and development model (PCD) proposes several interdependent factors that enable organizational-level change and thus accounts for the complex settings of primary care practices. Leveraging the PCD, we seek to answer the following research questions: Which combinations of internal and external factors based on the PCD contribute to successful implementation in primary care practices? Given these results, how can implementation in the primary care setting be improved? METHODS: We analyzed the joint contributions of internal and external factors on implementation success using qualitative comparative analysis (QCA). QCA is a set-theoretic approach that allows to identify configurations of multiple factors that lead to one outcome (here: successful implementation of a CDSS in primary care practices). Using survey data, we conducted our analysis based on a sample of 224 primary care practices. RESULTS: We identified two configurations of internal and external factors that likewise enable successful implementation. The first configuration enables implementation based on a combination of Strong Inside Motivation, High Capability for Development, and Strong Outside Motivation; the second configuration based on a combination of Strong Inside Motivators, Many Options for Development and the absence of High Capability for Development. CONCLUSION: In line with the PCD, our results demonstrate the importance of the combination of internal and external factors for implementation outcomes. Moreover, the two identified configurations show that different ways exist to achieve successful implementation in primary care practices. TRIAL REGISTRATION: AdAM was registered on ClinicalTrials.gov ( NCT03430336 ) on February 6, 2018.

How is leadership behavior associated with organization-related variables? Translation and psychometric evaluation of the implementation leadership scale in German primary healthcare.

BACKGROUND: The Implementation Leadership Scale (ILS) was developed to assess leadership behavior with regard to being proactive, knowledgeable, supportive, or perseverant in implementing evidence-based practices (EBPs). As part of a study on the implementation of a digitally supported polypharmacy management application in primary care, the original ILS was translated and validated for use in the German language. RATIONALE: This study aimed to translate the original ILS into German and evaluate its psychometric properties. METHODS: The validation sample consisted of 198 primary care physicians in a cluster-randomized controlled trial in which the intervention group implemented a digitally supported clinical decision support system for polypharmacy management. The ILS was assessed using a 12-item scale. The study included a process evaluation with two evaluation waves between 2019 and 2021. The ILS was used within this process evaluation study to assess the leadership support with regard to the implementation of the polypharmacy management. The ILS was translated in a multi-step process, including pre-testing of the instrument and triple, back-and-forth translation of the instrument. We tested the reliability (Cronbach's alpha) and validity (construct and criterion-related validity) of the scale. RESULTS: The four-dimensional structure of the instrument was confirmed (comparative fit index = .97; root mean square error of approximation = .06). Convergent validity was demonstrated by correlations with organizational innovation climate, social capital, and workload, which was consistent with the proposed hypothesis. Criterion-related validity of the ILS was demonstrated by predicting the organizational readiness for change scores using structural equation modeling. The reliability of the scale was good (α = .875). CONCLUSION: The German version of the ILS created in this study is a reliable and valid measure. The original four-dimensional structure of the ILS was confirmed in a primary care setting. Further psychometric testing is needed to establish the validity and reliability of the ILS and to transfer it to other health care settings. It is a useful tool for identifying the areas for implementation leadership development. Further research is needed on how, why, and when distinct types of leadership behaviors have different effects on healthcare organizations in implementation processes.

"I must, and I can live with that": a thematic analysis of patients' perspectives on polypharmacy and a digital decision support system for GPs.

BACKGROUND: To investigate patients' perspectives on polypharmacy and the use of a digital decision support system to assist general practitioners (GPs) in performing medication reviews. METHODS: Qualitative interviews with patients or informal caregivers recruited from participants in a cluster-randomized controlled clinical trial (cRCT). The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: We conducted 13 interviews and identified the following seven themes: the patients successfully integrated medication use in their everyday lives, used medication plans, had both good and bad personal experiences with their drugs, regarded their healthcare providers as the main source of medication-related information, discussed medication changes with their GPs, had trusting relationships with them, and viewed the use of digital decision support tools for medication reviews positively. No unwanted adverse effects were reported. CONCLUSIONS: Despite drug-related problems, patients appeared to cope well with their medications. They also trusted their GPs, despite acknowledging polypharmacy to be a complex field for them. The use of a digital support system was appreciated and linked to the hope that reasons for selecting specific medication regimens would become more comprehensible. Further research with a more diverse sampling might add more patient perspectives. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03430336 . Registered on February 6, 2018.

Digital Medication Management in Polypharmacy.

BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.

Complex implementation mechanisms in primary care: do physicians' beliefs about the effectiveness of innovation play a mediating role? Applying a realist inquiry and structural equation modeling approach in a formative evaluation study.

BACKGROUND: The adoption of digital health technologies can improve the quality of care for polypharmacy patients, if the underlying complex implementation mechanisms are better understood. Context effects play a critical role in relation to implementation mechanisms. In primary care research, evidence on the effects of context in the adoption of digital innovation for polypharmacy management is lacking. STUDY AIM: This study aims to identify contextual factors relevant to physician behavior and how they might mediate the adoption process. METHODS: The physicians who participated in this formative evaluation study (n = 218) were part of the intervention group in a cluster-randomized controlled trial (AdAM). The intervention group implemented a digital innovation for clinical decision making in polypharmacy. A three-step methodological approach was used: (1) a realist inquiry approach, which involves the description of a context-mechanism-outcome configuration for the primary care setting; (2) a belief elicitation approach, which involves qualitative content analysis and the development of a quantitative latent contextualized scale; and (3) a mediation analysis using structural equation modeling (SEM) based on quantitative survey data from physicians to assess the mediating role of the contextualized scale (n = 179). RESULTS: The key dimensions of a (1) context-mechanism-outcome model were mapped and refined. A (2) latent construct of the physicians' innovation beliefs related to the effectiveness of polypharmacy management practices was identified. Innovation beliefs play a (3) mediating role between the organizational readiness to implement change (p < 0.01) and the desired behavioral intent of physicians to adopt digital innovation (p < 0.01; R2 = 0.645). Our contextualized model estimated significant mediation, with a relative size of 38% for the mediation effect. Overall, the model demonstrated good fit indices (CFI = 0.985, RMSEA = 0.034). CONCLUSION: Physician adoption is directly affected by the readiness of primary care organizations for the implementation of change. In addition, the mediation analysis revealed that this relationship is indirectly influenced by primary care physicians' beliefs regarding the effectiveness of digital innovation. Both individual physician beliefs and practice organizational capacity could be equally prioritized in developing implementation strategies. The methodological approach used is suitable for the evaluation of complex implementation mechanisms. It has been proven to be an advantageous approach for formative evaluation. TRIAL REGISTRATION: NCT03430336 . First registration: 12/02/2018. CLINICALTRIALS: gov.

Use of an electronic medication management support system in patients with polypharmacy in general practice: study protocol of a quantitative process evaluation of the AdAM trial.

BACKGROUND: Interventional studies on polypharmacy often fail to significantly improve patient-relevant outcomes, or confine themselves to measuring surrogate parameters. Interventions and settings are complex, with many factors affecting results. The AdAM study's aim is to reduce hospitalization and death by requiring general practitioners (GPs) to use a computerized decision-support system (CDSS). The study will undergo a process evaluation to identify factors for successful implementation and to assess whether the intervention was implemented as intended. OBJECTIVE: To evaluate our complex intervention, based on the Medical Research Council's guideline dimensions. RESEARCH QUESTIONS: We will assess implementation (reach, fidelity, dose, tailoring) by asking: (1) Who took part in the intervention (proportion of GPs using the CDSS, proportion of patients enrolled in them)? Information on GPs' and patients' characteristics will also be collected. (2) How many and which medication alerts were dealt with? (3) Was the intervention implemented as intended? (4) On what days did GPs use the intervention tool? METHODS: The process evaluation is part of a stepped-wedge cluster-randomized controlled trial. Characteristics of practices, GPs and patients using the CDSS will be compared with the non-participating population. CDSS log data will be analyzed to evaluate how the number of medication alerts changed between baseline and 2 months later, and to identify the kind of alerts that were dealt with. Comparison of enrolled patients on weekdays versus weekends will shed light on GPs' use of the CDSS in the absence or presence of patients. Outcomes will be presented using descriptive statistics, and significance tests will be used to identify associations between them. We will conduct subgroup analyses, including time effects to account for software improvements. DISCUSSION: This study protocol is the basis for conducting analyses of the quantitative process evaluation. By providing insight into how GPs conduct medication reviews, the evaluation will provide context to the trial results and support their interpretation. The evaluation relies on the proper documentation by GPs, potentially limiting its explanatory power.

Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM).

INTRODUCTION: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. METHODS AND ANALYSIS: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. SCOPE: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. POPULATION: patients (≥18 years) with polypharmacy (≥5 prescriptions). SAMPLE SIZE: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. INTERVENTION: complex intervention eMMa. FOLLOW-UP: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. OUTCOMES: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. STATISTICAL ANALYSIS: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints. ETHICS AND DISSEMINATION: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences. TRIAL REGISTRATION: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy.

OBJECTIVE: Formative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process. METHODS/SETTING: Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways). RESULTS: Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians' interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators. CONCLUSION: Our analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects. TRIAL REGISTRATION: NCT03430336 , 12 February 2018.