German Clinical Trials Register

Acronym/abbreviation of the study

Medication plan

URL of the study

No Entry

Brief summary in lay language

The study is aimed at doctors and aims to improve cooperation between practitioners for the benefit of the patient. Many patients have to take three or more medications on a long-term basis due to coexisting or chronic illnesses and are entitled to the Federal Uniform Medication Plan (BMP). Within this study, an app is available to the patients, which provides a digital version by scanning the BMP QR code and which enables it to be passed on to other (specialist) doctors. The prescription and control of several drugs poses major challenges for general practitioners and specialists. This study aims to review the appropriateness of medication for patients eligible for a BMP, with the aim of improving drug therapy safety and reducing side effects. Self-medication and habits (smoking, alcohol and nicotine consumption) are recorded and can be taken into account when optimizing medication. Notes on taking, including possible reminders on the time of taking on the mobile phone, are intended to improve adherence to therapy and the success of the therapy.

Brief summary in scientific language

Background: The prevalent polymedication increases the risk of adverse drug events and treatment failure. Monitoring and adapting medication poses a challenge in medical practice. In addition, the pharmacokinetics and dynamics of many drugs change with age, which also increases the risk of drug-related problems. Without the use of a computer system, the consideration of all drug interactions, age-related recommendations (Beers, Priscus, FORTA), food, consumption and self-medication interactions, laboratory values (liver, kidney) and, if available, genetic or physiological peculiarities (CYPs, Phase II, transporters, targets) is practically impossible. Adverse drug events can also be the result of suboptimal communication processes between the practitioners involved and are also a frequent reason for CIRS reports and hospital admissions. Therefore, the monitoring of drug therapy has a special priority. In practice, however, the documentation and intersectoral communication required to cope with this task is often in need of improvement and there is often no systematic review of the medication. The aim of the study is therefore to optimize drug therapy by checking potentially inappropriate medications (PIMs) and improving cooperation and communication between the practitioners and patients involved. A medication score indicates problems and allows the practitioner a personalized, interactive optimization. Research questions: 1) Can the appropriateness of medication (PIMs) be improved by using the app? 2.) Can the medication score be improved by using the app? 3.) Can the subjective health-related quality of life (QoL) be improved by using the app? Primary Endpoints: Medication Appropriateness (PIMs); Medication score (Borro, 2021) t0, t1 after 3 months, t2 after 6 months Secondary endpoints are: 1.) Subjective health-related quality of life of the patient, recorded using SEALS 2.) Reduction of side effects (in-app PROMs) Study population: The study population includes patients with a present BMP who are willing to use a smartphone to manage their medication plan Study design: Controlled, randomized clinical study The national medication plan is required by law for patients with three or more drugs. So far, patients have carried it with them in paper form. The study participants are randomly assigned (by envelope) to the app user group and the control group (no app use). In the app to be examined, the medication plan is available in structured form on a mobile device by scanning the QR code. Patients are reminded by their smartphone to take their medication and can share their medication with their attending physicians. The patients can grant the practitioners access to the optimization system (web application) including their data. The medication of the study participants is analyzed with regard to the number and severity of PIMs. An interactive total score is determined, which results from the sum of drug interactions and individual factors (such as age, gender, BMI, laboratory values, etc.). It also shows "potentially inappropriate medications" (PIMs). This greatly facilitates the exchange of unsuitable drugs with individually better suited drugs. The resulting change in medication is monitored and analyzed. In addition, the participants are notified automatically to take medication, which increases compliance. A validated questionnaire is used to quantify the Patient Reported Outcome Measures (PROMs) (SEALS: Side Effects And Life Satisfaction; PubMed ID: 8800634, 10803823). The improvement of the cooperation and communication between the participating practitioners and patients is measured by recording the intersectoral creation of BMPs by the practitioner and the temporal development of the recording of side effects and self-medication by the patient.