CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 614 enrolled
Drug / intervention
ISTOP-ADEother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02059044
NCT02059044N/ACompleted

Information Systems-enabled Outreach Program for Adverse Drug Events

Ottawa Hospital Research Institute·interventional·Posted Feb 11, 2014·Updated May 28, 2020

In Brief

A clinical study evaluating ISTOP-ADE for Adverse Drug Events. Completed, enrolled 614 participants across 1 site.

Detailed Summary

One of the most common health care interventions in any healthcare setting is a medication prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences. The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who contacted the patient, modified the therapy accordingly, and informed a physician when necessary. The pilot project included 568 patients with diverse illnesses in two Canadian cities. High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non-compliance events. Very few episodes of ameliorable ADEs were observed. The investigators feel these results justify a randomized control trial to assess the effectiveness of the intervention for improving patient centered outcomes. Ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. The investigators expect that the system will reduce the severity and duration of outpatient ADEs and improve adherence to medication care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartOct 15, 2015
Primary CompletionAug 31, 2018
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.4 years ago

Interventions

ISTOP-ADEother

Interactive Voice Response System + Pharmacist