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Application for an Electronic Medication Management Support System (AdAM)

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ClinicalTrials.gov Identifier: NCT03430336
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
Association of Statutory Health Insurance Physicians Westphalia/Lippe
Goethe University
University of Cologne
Ruhr University of Bochum
Bielefeld University
Information provided by (Responsible Party):
Christiane Muth, MD, MPH, Goethe University

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date February 12, 2018
Estimated Study Start Date  ICMJE February 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2018)
Cost Effectiveness [ Time Frame: observation period of 15 months ]
Cost-effectiveness of the intervention will be measured by the incremental cost-effectiveness ratio (ICER), which is expressed as the ratio of the difference in overall costs between the control and the intervention group and the difference in effects between both groups.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Application for an Electronic Medication Management Support System
Official Title  ICMJE Effectiveness and Cost-effectiveness of the Application of an Electronic Medication Management Support System in Patients With Polypharmacy in General Practice (AdAM).
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Due to the character of the intervention, a blinding is not possible.
Primary Purpose: Health Services Research
Condition  ICMJE Polypharmacy
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: CDSS provides drug-therapy relevant information
    • Other: Modification of medication
    • Other: Assessment of medication appropriateness
    • Other: Medication plan
    • Other: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
34400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christiane Muth, MD, MPH +49-69-6301-4149/-5687 muth@allgemeinmedizin.uni-frankfurt.de
Contact: Hans-Joachim Trampisch, Dr.rer.nat. +49-23-4322-7790 Hans.J.Trampisch@ruhr-uni-bochum.de
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430336
Other Study ID Numbers  ICMJE IfA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christiane Muth, MD, MPH, Goethe University
Study Sponsor  ICMJE BARMER
Collaborators  ICMJE
  • Association of Statutory Health Insurance Physicians Westphalia/Lippe
  • Goethe University
  • University of Cologne
  • Ruhr University of Bochum
  • Bielefeld University
Investigators  ICMJE
Study Director: Petra Kellermann-Mühlhoff BARMER Health Insurance
PRS Account BARMER
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP