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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Ottawa Hospital Research Institute
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McGill University
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT02059044
First received: January 10, 2014
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Adverse Drug Events
Other: ISTOP-ADE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Information Systems-enabled Outreach Program for Adverse Drug Events

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Failure to persist with medication regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients experiencing an ADE [ Time Frame: within 30 days of prescription ] [ Designated as safety issue: No ]
  • Duration of symptoms attributable to the ADE from start to resolution [ Time Frame: within 21 days following prescription ] [ Designated as safety issue: No ]
  • ADE resulting in an Emergency Department (ED) or inpatient encounter [ Time Frame: within 21 days following prescription ] [ Designated as safety issue: No ]
  • ADE severity [ Time Frame: within 30 days of prescription ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing an ameliorable ADE [ Time Frame: within 30 days of prescription ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cost of intervention for each patient [ Time Frame: 21 days following prescription (average) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISTOP-ADE
Interactive Voice Response System + Pharmacist
Other: ISTOP-ADE
Interactive Voice Response System + Pharmacist
No Intervention: Routine care
Routine 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059044

Contacts
Contact: Alison E Jennings, BSc MA 6137985555 ext 19717 ajennings@ohri.ca

Locations
Canada, Quebec
McGill University Not yet recruiting
Montreal, Quebec, Canada, H3A1A3
Contact: Bejamin Pyenson, MSc    5148863313    benjamin.pyenson@mail.mcgill.ca   
Principal Investigator: Robyn Tamblyn, PhD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
McGill University
Investigators
Principal Investigator: Alan J Forster, MD FRCPC MSc Ottawa Hospital Research Institute
  More Information

Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02059044     History of Changes
Other Study ID Numbers: 20130285, MOP125975
Study First Received: January 10, 2014
Last Updated: October 15, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
patient safety
pharmacoepidemiology
health services research
adherence
information technology

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 22, 2014