Clinical Trial: Information Systems-enabled Outreach Program for Adverse Drug Events
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Information Systems-enabled Outreach Program for Adverse Drug Events
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 Summary:
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 thr
Sponsor: Ottawa Hospital Research Institute
Current Primary Outcome: Failure to persist with medication regimen [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients experiencing an ADE [ Time Frame: within 30 days of prescription ]
- Duration of symptoms attributable to the ADE from start to resolution [ Time Frame: within 21 days following prescription ]
- ADE resulting in an Emergency Department (ED) or inpatient encounter [ Time Frame: within 21 days following prescription ]
- ADE severity [ Time Frame: within 30 days of prescription ]
- Proportion of patients experiencing an ameliorable ADE [ Time Frame: within 30 days of prescription ]An 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) [ Time Frame: 1 year ]
Original Secondary Outcome:
- Proportion of patients experiencing an ADE [ Time Frame: within 30 days of prescription ]
- Duration of symptoms attributable to the ADE from start to resolution [ Time Frame: within 21 days following prescription ]
- ADE resulting in an Emergency Department (ED) or inpatient encounter [ Time Frame: within 21 days following prescription ]
- ADE severity [ Time Frame: within 30 days of prescription ]
- Proportion of patients experiencing an ameliorable ADE [ Time Frame: within 30 days of prescription ]An 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, and days in hospital) [ Time Frame: 1 year ]
Information By: Ottawa Hospital Research Institute
Dates:
Date Received: January 10, 2014
Date Started: October 2015
Date Completion: January 2020
Last Updated: August 4, 2016
Last Verified: August 2016
