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Information Systems-enabled Outreach Program for Adverse Drug Events

Information Systems-enabled Outreach Program for Adverse Drug Events

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02059044
Acronym
ISTOP-ADE
Enrollment
614
Registered
2014-02-11
Start date
2015-10-15
Completion date
2019-03-31
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Events

Keywords

patient safety, pharmacoepidemiology, health services research, adherence, information technology

Brief 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.

Detailed description

One of the most common health care interventions in any healthcare setting is a medication prescription. On an individual and population level, outpatient medication use has the potential to improve health. 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 subsequently 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 (Montreal and Quebec City). The system successfully contacted 477 patients (84%). 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 in which the ADE severity could have been diminished with more appropriate management. The investigators feel these results justify a randomized control trial to assess the effectiveness of our intervention for improving patient-centered outcomes. To determine whether the system reduces the severity and duration of outpatient ADEs and improves adherence to medication care at three and 12 months, 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. As an exploratory analysis, the impact of the intervention on patient self efficacy and health services use will also be examined. This study will help to define whether this promising intervention can improve patient health from both the individual patient and population health perspective. There is a wide scope of potential applications for this approach. This study will provide important information to guide these future applications beyond the specific question asked in this protocol.

Interventions

OTHERISTOP-ADE

Interactive Voice Response System + Pharmacist

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McGill University
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* spoken language is French or English * physician is a user of MOXXI (electronic health record system) and patient has consented to be captured by MOXXI * receiving a high-risk incident prescription * medication insurance through Regie de l'Assurances Maladie du Quebec (RAMQ) insurance program

Exclusion criteria

* patient not appropriate for inclusion (as determined by prescribing physician)

Design outcomes

Primary

MeasureTime frame
Failure to persist with medication regimen6 months

Secondary

MeasureTime frameDescription
Proportion of patients experiencing an ADEwithin 30 days of prescription
Duration of symptoms attributable to the ADE from start to resolutionwithin 21 days following prescription
ADE resulting in an Emergency Department (ED) or inpatient encounterwithin 21 days following prescription
Proportion of patients experiencing an ameliorable ADEwithin 30 days of prescriptionAn ameliorable ADE is an ADE whose severity should have been reduced if the healthcare system responded to the patient's health issues in an appropriate manner
Healthcare utilization (number of visits to MDs, EDs, days in hospital, and medication claims)1 year
ADE severitywithin 30 days of prescription

Other

MeasureTime frame
Cost of intervention for each patient21 days following prescription (average)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026