NCT02059044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 15, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

January 10, 2014

Last Update Submit

May 27, 2020

Conditions

Adverse Drug Events

Keywords

patient safetypharmacoepidemiologyhealth services researchadherenceinformation technology

Outcome Measures

Primary Outcomes (1)

  • Failure to persist with medication regimen

    6 months

Secondary Outcomes (6)

  • 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

    within 30 days of prescription

  • +1 more secondary outcomes

Other Outcomes (1)

  • Cost of intervention for each patient

    21 days following prescription (average)

Study Arms (2)

ISTOP-ADE

EXPERIMENTAL

Interactive Voice Response System + Pharmacist

Other: ISTOP-ADE

Routine care

NO INTERVENTION

Routine care

Interventions

ISTOP-ADEOTHER

Interactive Voice Response System + Pharmacist

ISTOP-ADE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A1A3, Canada

Location

Related Publications (8)

  • 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.

    PMID: 19514804BACKGROUND

  • 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.

    PMID: 19156467BACKGROUND

  • 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.

    PMID: 18611094BACKGROUND

  • 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.

    PMID: 17518797BACKGROUND

  • 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.

    PMID: 19398739BACKGROUND

  • 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.

    PMID: 23396853BACKGROUND

  • 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.

    PMID: 23381469BACKGROUND

  • 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.

    PMID: 25572800DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Alan J Forster, MD FRCPC MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

February 11, 2014

Study Start

October 15, 2015

Primary Completion

August 31, 2018

Study Completion

March 31, 2019

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

CA(1)