Information Systems-enabled Outreach Program for Adverse Drug Events (ISTOP-ADE)

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 Overview

• Status: Completed
• Conditions: Adverse Drug Events
• Intervention / Treatment: Other: ISTOP-ADE

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.

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A1A3
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ISTOP-ADE; Interactive Voice Response System + Pharmacist	Other: ISTOP-ADE; Interactive Voice Response System + Pharmacist
NO_INTERVENTION: Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure to persist with medication regimen	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients experiencing an ADE		within 30 days of prescription
Duration of symptoms attributable to the ADE from start to resolution		within 21 days following prescription
ADE resulting in an Emergency Department (ED) or inpatient encounter		within 21 days following prescription
ADE severity		within 30 days of prescription
Proportion of patients experiencing an ameliorable ADE	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	within 30 days of prescription
Healthcare utilization (number of visits to MDs, EDs, days in hospital, and medication claims)		1 year

Other Outcome Measures

Outcome Measure	Time Frame
Cost of intervention for each patient	21 days following prescription (average)

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: McGill University; Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Alan J Forster, MD FRCPC MSc, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Forster AJ, LaBranche R, McKim R, Faught JW, Feasby TE, Janes-Kelley S, Shojania KG, van Walraven C. Automated patient assessments after outpatient surgery using an interactive voice response system. Am J Manag Care. 2008 Jul;14(7):429-36.
• Oake N, Jennings A, van Walraven C, Forster AJ. Interactive voice response systems for improving delivery of ambulatory care. Am J Manag Care. 2009 Jun;15(6):383-91.
• Forster AJ, Boyle L, Shojania KG, Feasby TE, van Walraven C. Identifying patients with post-discharge care problems using an interactive voice response system. J Gen Intern Med. 2009 Apr;24(4):520-5. doi: 10.1007/s11606-009-0910-3. Epub 2009 Jan 21.
• Forster AJ, van Walraven C. Using an interactive voice response system to improve patient safety following hospital discharge. J Eval Clin Pract. 2007 Jun;13(3):346-51. doi: 10.1111/j.1365-2753.2006.00702.x.
• Oake N, van Walraven C, Rodger MA, Forster AJ. Effect of an interactive voice response system on oral anticoagulant management. CMAJ. 2009 Apr 28;180(9):927-33. doi: 10.1503/cmaj.081659.
• Auger C, Forster AJ, Oake N, Tamblyn R. Usability of a computerised drug monitoring programme to detect adverse drug events and non-compliance in outpatient ambulatory care. BMJ Qual Saf. 2013 Apr;22(4):306-16. doi: 10.1136/bmjqs-2012-001492. Epub 2013 Feb 8.
• Forster AJ, Auger C; ISTOP ADE Investigators. Using information technology to improve the monitoring of outpatient prescribing. JAMA Intern Med. 2013 Mar 11;173(5):382-4. doi: 10.1001/jamainternmed.2013.2002. No abstract available.
• Forster AJ, Erlanger TE, Jennings A, Auger C, Buckeridge D, van Walraven C, Tamblyn R. Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial. Trials. 2015 Jan 8;16:2. doi: 10.1186/1745-6215-16-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2015
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (ESTIMATE): February 11, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: adherence; health services research; patient safety; information technology; pharmacoepidemiology
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 20130285; MOP125975 (OTHER_GRANT: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED