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)

Müller, Beate S.; Klaaßen-Mielke, Renate; González‐González, Ana Isabel; Grandt, Daniel; Hammerschmidt, Reinhard; Köberlein-Neu, Juliane; Kellermann-Mühlhoff, Petra; Trampisch, Hans J.; Beckmann, Till; Düvel, Lara; Surmann, Bastian; Flaig, Berthold Bodo; Ihle, Peter; Söling, Sara; Grandt, Simone; Dinh, Truc Sophia; Piotrowski, Alexandra; Meyer, Ingo; Karbach, Ute; Harder, Sebastian; Perera, Rafael; Glasziou, Paul; Pfaff, Holger; Greiner, Wolfgang; Gerlach, Ferdinand M.; Timmesfeld, Nina; Muth, Christiane

doi:10.1136/bmjopen-2020-048191

Cited by 11 publications

(13 citation statements)

References 34 publications

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“…The approach of the AdAM intervention ("Anwendung für ein digital gestütztes Arzneimitteltherapie-und Versorgungsmanagement", or "application of digitally supported drug-therapy and care management") is described in detail elsewhere [41]. In short, the intervention foresees that GPs perform at least one medication review in adult patients receiving five or more chronic medications with the help of a CDSS (software was developed under the name "eMMa", which is an abbreviation for electronic medication management) that has been fed with all relevant medical information in the form of claims data from the statutory health insurance company BARMER.…”

Section: Background Information On the Adam Studymentioning

confidence: 99%

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial

Brünn

Lemke²,

Basten³

et al. 2022

Pharmaceuticals

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Polypharmacy is associated with a risk of negative health outcomes. Potentially inappropriate medications, interactions resulting from contradicting medical guidelines, and inappropriate monitoring, all increase the risk. This process evaluation (PE) of the AdAM study investigates implementation and use of a computerized decision-support system (CDSS). The CDSS analyzes medication appropriateness by including claims data, and hence provides general practitioners (GPs) with full access to patients’ medical treatments. We based our PE on pseudonymized logbook entries into the CDSS and used the four dimensions of the Medical Research Council PE framework. Reach, which examines the extent to which the intended study population was included, and Dose, Fidelity, and Tailoring, which examine how the software was actually used by GPs. The PE was explorative and descriptive. Study participants were representative of the target population, except for patients receiving a high level of nursing care, as they were treated less frequently. GPs identified and corrected inappropriate prescriptions flagged by the CDSS. The frequency and intensity of interventions documented in the form of logbook entries lagged behind expectations, raising questions about implementation barriers to the intervention and the limitations of the PE. Impossibility to connect the CDSS to GPs’ electronic medical records (EMR) of GPs due to technical conditions in the German healthcare system may have hindered the implementation of the intervention. Data logged in the CDSS may underestimate medication changes in patients, as documentation was voluntary and already included in EMR.

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Section: Background Information On the Adam Studymentioning

confidence: 99%

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial

Brünn

Lemke²,

Basten³

et al. 2022

Pharmaceuticals

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“…The use of a composite endpoint as hospital admission or death is proposed as recommended by some European studies, in order to compare the results with these studies [ 28 , 60 , 61 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, more quality studies are needed to establish evidence of its effectiveness and cost-effectiveness in conditions of routine clinical practice [ 26 , 27 ]. At the European level, some initiatives have been launched that attempt to overcome these limitations [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial

del-Cura-González

López-Rodríguez²,

Leiva-Fernández³

et al. 2022

Trials

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Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65–74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019

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“…In this secondary analysis, data from two surveys were used to examine the psychometric parameters of the German version of the ILS. The data were collected as part of the formative evaluation accompanying the effectiveness study in the project “Application of a digitally supported pharmacotherapy management system” (AdAM project), which was conducted in PCP practices from 2017 to 2021 [ 35 ]. The design of the effectiveness study influenced the data collection of this study.…”

Section: Methodsmentioning

confidence: 99%

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

Söling

Pfaff²,

Karbach³

et al. 2022

BMC Health Serv Res

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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.

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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)

Cited by 11 publications

References 34 publications

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial

Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial

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

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