Information Systems-enabled Outreach Program for Adverse Drug Events (ISTOP-ADE)
Primary Purpose
Adverse Drug Events
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ISTOP-ADE
Sponsored by
About this trial
This is an interventional health services research trial for Adverse Drug Events focused on measuring patient safety, pharmacoepidemiology, health services research, adherence, information technology
Eligibility Criteria
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)
Sites / Locations
- McGill University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ISTOP-ADE
Routine care
Arm Description
Interactive Voice Response System + Pharmacist
Routine care
Outcomes
Primary Outcome Measures
Failure to persist with medication regimen
Secondary Outcome Measures
Proportion of patients experiencing an ADE
Duration of symptoms attributable to the ADE from start to resolution
ADE resulting in an Emergency Department (ED) or inpatient encounter
ADE severity
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
Healthcare utilization (number of visits to MDs, EDs, days in hospital, and medication claims)
Full Information
NCT ID
NCT02059044
First Posted
January 10, 2014
Last Updated
May 27, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University
1. Study Identification
Unique Protocol Identification Number
NCT02059044
Brief Title
Information Systems-enabled Outreach Program for Adverse Drug Events
Acronym
ISTOP-ADE
Official Title
Information Systems-enabled Outreach Program for Adverse Drug Events
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
patient safety, pharmacoepidemiology, health services research, adherence, information technology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISTOP-ADE
Arm Type
Experimental
Arm Description
Interactive Voice Response System + Pharmacist
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Other
Intervention Name(s)
ISTOP-ADE
Intervention Description
Interactive Voice Response System + Pharmacist
Primary Outcome Measure Information:
Title
Failure to persist with medication regimen
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients experiencing an ADE
Time Frame
within 30 days of prescription
Title
Duration of symptoms attributable to the ADE from start to resolution
Time Frame
within 21 days following prescription
Title
ADE resulting in an Emergency Department (ED) or inpatient encounter
Time Frame
within 21 days following prescription
Title
ADE severity
Time Frame
within 30 days of prescription
Title
Proportion of patients experiencing an ameliorable ADE
Description
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
Time Frame
within 30 days of prescription
Title
Healthcare utilization (number of visits to MDs, EDs, days in hospital, and medication claims)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Cost of intervention for each patient
Time Frame
21 days following prescription (average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Forster, MD FRCPC MSc
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19514804
Citation
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.
Results Reference
background
PubMed Identifier
19156467
Citation
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.
Results Reference
background
PubMed Identifier
18611094
Citation
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.
Results Reference
background
PubMed Identifier
17518797
Citation
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.
Results Reference
background
PubMed Identifier
19398739
Citation
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.
Results Reference
background
PubMed Identifier
23396853
Citation
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.
Results Reference
background
PubMed Identifier
23381469
Citation
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.
Results Reference
background
PubMed Identifier
25572800
Citation
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.
Results Reference
derived
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Information Systems-enabled Outreach Program for Adverse Drug Events
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