Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial

Dürr, Pauline; Meier, Florian; Schlichtig, Katja; Schramm, Anja; Schötz, Lukas; Fromm, Martin F.; Dörje, Frank

doi:10.3390/jcm11216392

Cited by 3 publications

(1 citation statement)

References 31 publications

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“…In conclusion, patients and treatment teams should be addressed to optimize medication safety with OAT [13,14]. Moreover, the AMBORA care program had positive effects on the healthcare system by reducing the cost via cutting the amount of wasted, expensive oral antitumor medications due to treatment discontinuation [16] or reduced hospitalization rates [17].…”

Section: Introductionmentioning

confidence: 99%

Optimizing Medication Safety with Oral Antitumor Therapy: A Methodological Approach for the Real-World Implementation of the AMBORA Competence and Consultation Center

et al. 2023

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Generating evidence for the efficacy of an intervention is not sufficient to guarantee its implementation in real-world settings. The randomized AMBORA trial (Medication Safety with Oral Antitumor Therapy) demonstrated that an intensified clinical pharmacological/pharmaceutical care program has substantial benefits for patients, treatment teams, and the healthcare system. Thus, we are now investigating its implementation into routine care within the AMBORA Competence and Consultation Center (AMBORA Center). We perform a multicenter type III hybrid trial following the RE-AIM framework to assess the clinical effectiveness of this care program under real-world conditions, while evaluating the implementation outcomes. Semi-structured stakeholder interviews based on the Consolidated Framework for Implementation Research (CFIR) have been conducted to identify barriers and facilitators. So far, 332 patients treated with oral antitumor drugs have been referred to the AMBORA Center by 66 physicians from 13 independent clinical units. In 20 stakeholder interviews (e.g., with clinic directors), 30% (6/20) of the interviewees anticipated possible barriers which may partly hinder sustainable implementation (e.g., unavailable consultation rooms). Furthermore, important facilitators (e.g., operational processes) were identified. This methodological description adds knowledge on how to structure a hybrid effectiveness–implementation trial and proposes multilevel implementation strategies to improve the medication safety of oral antitumor therapy.

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Section: Introductionmentioning

confidence: 99%

Optimizing Medication Safety with Oral Antitumor Therapy: A Methodological Approach for the Real-World Implementation of the AMBORA Competence and Consultation Center

et al. 2023

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Early follow-up of outpatients with oral anticancer therapy in the ONCORAL multidisciplinary community-hospital program

Lattard,

Herledan,

Reverdy

et al. 2024

The Oncologist

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Background Healthcare professionals are faced with the new challenges of preventing and managing drug-related problems (DRPs) with oral anticancer therapy (OAT): side-effects, drug–drug interactions (DDIs), non-adherence, or medication errors. This study aims to assess the impact of ONCORAL, a real-life multidisciplinary care plan for cancer patients based on community and hospital follow-up, for the first OAT cycle. Methods A prospective cohort study was conducted between October 1, 2021 and October 1, 2022 including all outpatients starting OAT treatment. During the first OAT cycle, the program consists of 6 weekly scheduled face-to-face or phone consultations to prevent and manage DRPs. Nurse and pharmacist interventions (NPIs) are realized to optimize treatments (primary outcomes). Secondary outcomes included the relative dose intensity (RDI) of the first cycle. Results A total of 562 NPIs were performed by the ONCORAL team: that is, 87.1% of the 209 patients included, for a mean of 3.1 ± 2.2 NPIs/patient. NPIs-concerned DRPs detected by the nurse and pharmacist (346, 61.6%), symptoms and/or adverse effects reported as PROs by the patient or family (138, 24.6%), or pathway issues (78, 13.9%). Seventy-three DDIs were detected and managed during medication review, in a quarter of patients (n = 54/209), leading to the discontinuation of a daily concomitant medication in 30 cases. The mean RDI at the end of the first cycle, calculated for 209 patients, was 83.1 ± 23.9% (17.56-144.23). Conclusion In these ambulatory cancer patients, the interest in tailored monitoring of DRPs as a whole, including the prevention and management of drug interactions in addition to symptoms and adverse effects, is highlighted.

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A Hybrid Type III Effectiveness-Implementation Trial to Optimize Medication Safety With Oral Antitumor Therapy in Real-World: The AMBORA Competence and Consultation Center

Cuba,

Dürr,

Gessner

et al. 2024

JCO Oncol Pract

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PURPOSE Implementation science endeavors to facilitate the translation of evidence-based research into clinical routine. The clinical pharmacological/pharmaceutical care program evaluated in the randomized AMBORA trial on medication safety with oral antitumor therapeutics (OAT) optimizes care delivery and provides significant benefits for patients, treatment teams, and health care systems. Thus, we aimed to investigate the implementation of this care program within the AMBORA Competence and Consultation Center (AMBORA Center). METHODS The AMBORA Center within a University Comprehensive Cancer Center offered several services (eg, patient consultations) and was evaluated according to the RE-AIM framework. This multicenter hybrid type III trial focused on implementation outcomes (eg, patient recruitment, referring units, evaluation of services) while concurrently investigating effectiveness (eg, side effects, medication errors). Quantitative and qualitative assessments were combined. RESULTS The AMBORA Center conducted over 800 consultations with 420 patients in seven institutions. The primary end point of counseling 70% of patients treated with OAT was not reached. Patients were referred by 15 treatment units compared with 11 units in the AMBORA trial. On the basis of heterogeneous referral rates and characteristics across the institutions, barriers and facilitators of the implementation process were derived. Several survey results (eg, stakeholder interviews, online/paper-based questionnaires) reflected a high appreciation of services by patients and health care professionals. The severity of 60.1% (178 of 296) of detected side effects improved, and 86.3% (297 of 344) of medication errors were resolved. CONCLUSION Despite not reaching the primary implementation outcome, the AMBORA Center included more treatment units and demonstrated patient benefit of the AMBORA care program by meeting all effectiveness outcomes. We outlined quantitative and qualitative implementation characteristics to enhance outreach and foster further dissemination of centers to optimize medication safety with OAT.

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Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial

Cited by 3 publications

References 31 publications

Optimizing Medication Safety with Oral Antitumor Therapy: A Methodological Approach for the Real-World Implementation of the AMBORA Competence and Consultation Center

Optimizing Medication Safety with Oral Antitumor Therapy: A Methodological Approach for the Real-World Implementation of the AMBORA Competence and Consultation Center

Early follow-up of outpatients with oral anticancer therapy in the ONCORAL multidisciplinary community-hospital program

A Hybrid Type III Effectiveness-Implementation Trial to Optimize Medication Safety With Oral Antitumor Therapy in Real-World: The AMBORA Competence and Consultation Center

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