Application for an Electronic Medication Management Support System

Overview

This study assesses whether an electronic medication management support system improves quality, safety, and cost-effectiveness of the drug therapy in adult patients with polypharmacy at fifteen (T1) months from baseline compared to usual care.

Full Title of Study: “Effectiveness and Cost-effectiveness of the Application of an Electronic Medication Management Support System in Patients With Polypharmacy in General Practice (AdAM).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Detailed Description

Title:

Application of an electronic medication management support system.

Objectives:

The aim of the study is to assess the effectiveness of an electronic medication management support system on hospitalization and death, its cost-effectiveness and its effects on the quality and safety of prescribing in patients with polypharmacy.

Methods:

A parallel, cluster-randomised controlled trial will be conducted in about 1,080 general practices located in the Westphalia-Region (Germany), which care for adult patients covered by BARMER health insurance. Per group, 17,200 clustered-randomized patients (about 32 patients per practice) will be included, if they take ≥ 5 long-term prescriptions (at least 2 consecutive quarters).

In the intervention group, family physicians will use an user-initiated clinical decision support system (CDSS) which provides drug-therapy relevant information (e.g. on diagnoses and treatments) and alerts in case of drug-drug, drug-disease and drug-age interactions. Based on that information, the family physician systematically assesses the appropriateness of patient's medication and optimizes it. Patients receive an updated medication plan in their mother's language, if needed.

In the control group, patients continue to receive usual care where there is no access to the CDSS.

The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions after 15 months. The outcome measures will be based on secondary data (i.e. claims data). Primary and secondary outcomes will be measured at patient level. The primary analysis will be performed adhering to the intention-to-treat (ITT) principle.

Interventions

  • Other: CDSS provides drug-therapy relevant information
    • External computerized decision support system (CDSS: RpDoc® eMMa Software, RpDoc® Solutions GmbH, Saarbruecken) provides drug-therapy relevant information about participating patients with polypharmacy on demand to the general practitioners (GPs) such as data about diagnoses and treatments. The information is based on claims data gathered from all health care professionals involved in the care of the patient (e.g. specialized physicians, other GPs, psychotherapists as well as data about hospital stays and prescription data from pharmacies).
  • Other: Modification of medication
    • GPs can add and modify patient’s data within the CDSS (e.g. remove drugs which are not taken by the patient anymore, add most recent laboratory findings about kidney function etc.) to enrich and update claims data based information.
  • Other: Assessment of medication appropriateness
    • GPs systematically assess the appropriateness of the medication supported by the CDSS, which will alert in case of drug-drug, drug-disease, and drug-age interactions as well as other inappropriateness, such as prescriptions with regard to incorrect dosage or Dear Doctor letters.
  • Other: Medication plan
    • GPs print out the updated medication plan including also recommendations for medication use and reasons for prescription in lay language (also available in foreign languages for patients with migration background) as well as recommendations on drugs to use / to avoid including over-the-counter drugs (OTC) (optional) and hand it out to the patient.
  • Other: Guidance in medication process
    • GPs receive guidance via the CDSS (e.g. recommendations addressing certain types of medication errors and high risk prescribing, developed by the German Society for Internal Medicine in collaboration with other scientific medical societies).

Arms, Groups and Cohorts

  • Experimental: Computer-assisted medication management
    • Family physician adds, modifies and optimizes medication in patient’s with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication: CDSS provides drug-therapy relevant information modification of medication assessment of medication appropriateness medication plan Guidance in medication process
  • No Intervention: Control arm
    • Patients will receive the usual clinical care based on current clinical practice guidelines during intervention period. After completion of trial, the patients in the control group will be invited to participate after written informed consent to receive the intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Combined endpoint of all-cause mortality and all-cause hospital admissions
    • Time Frame: observation period of 15 months
    • The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions (including night- and day-only admissions) in patients with polypharmacy.

Secondary Measures

  • Change in the appropriateness of prescriptions
    • Time Frame: observation period of 15 months
    • Change in the appropriateness of prescriptions: to ascertain whether the complex intervention improves the appropriateness of prescriptions (high-risk prescriptions) in patients with polypharmacy, at T1 minus T0 (T1-T0), measured as the absolute difference in number of inappropriate prescriptions per patient before and after the intervention.
  • Change in all-cause hospital admissions
    • Time Frame: observation period of 15 months
    • Change in all-cause hospital admissions: to evaluate whether the complex intervention reduces all-cause hospital admissions (including day- or night-only admissions) (number and duration) in patients with polypharmacy.
  • Change in all-cause mortality
    • Time Frame: observation period of 15 months
    • Change in all-cause mortality: to assess whether the complex intervention reduces all-cause mortality in patients with polypharmacy.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ≥ 18 years of age with polypharmacy (5 or more drugs taken for at least two quarters).
  • Informed consent.

Exclusion Criteria

  • Incapacitated patients without legal representative

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BARMER
  • Collaborator
    • Association of Statutory Health Insurance Physicians Westphalia/Lippe
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christiane Muth, MD, MPH, MD, MPH – Goethe University
  • Overall Official(s)
    • Petra Kellermann-Mühlhoff, Study Director, BARMER Health Insurance
  • Overall Contact(s)
    • Christiane Muth, MD, MPH, +49-69-6301-4149/-5687, muth@allgemeinmedizin.uni-frankfurt.de

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