Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03430336 |
| Other study ID # |
IfA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2018 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
BARMER |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 compared to usual care during the observation period of 15 months from baseline
per practice (from 2017 4th quarter to 2020 3rd quarter).
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 the observation period of 12 quarters or 15 months per practice. 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.
Amendment (07/04/2020):
The parallel group comparison will be conducted, as planned. However, the design of the
primary analysis will be changed into a cluster-randomised stepped wedge design with an open
cohort, as the recruitment to the target of N=1,080 practices was not reached. The changes of
the design will allow to safe the power of the trial of 80% to detect differences of the
combined primary outcome between both groups. The primary outcome as well as the ITT-analysis
were not changed. The changes of the design implied the following subsequent adaptations of
the protocol:
1. Arms and assigned interventions:
The GP practices of the intervention group will continue to provide the experimental
intervention as described in the experimental arm for the entire time in the trial.
The GP practices of the control arm (usual care, no intervention) will switch to the
experimental arm after five quarters control time and provide the experimental
intervention for the remaining time in the trial.
2. Case finding:
The BARMER creates lists of potentially eligible patients ("Potenzialpatienten") in GP
practices participating in the AdAM trial based on the fulfillment of
inclusion/exclusion criteria in claims data at each quarter between the first quarter
2018 and the third quarter of 2020.
Intervention practices receive the lists quarterly from the quarter after randomization
and control practices quarterly starting on the date of switch.
3. Informed consent:
The GPs in practices of the experimental arm (either they were randomized and assigned as
intervention practices at the beginning of the trial or they switch after the end of five
quarters control time) invite potentially eligible patients from the lists and ask for a
written informed consent.
