Evaluating ActionADE in Reducing Adverse Drug Reactions

NCT04568668 | Unknown DMC

• 1 other identifier: H18-01332
• Study Type: interventional
• Target: 3,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. The investigators designed ActionADE to enable rapid documentation of adverse drug events, and communication of standardized information across health sectors by integrating ActionADE with legacy systems. The investigators will leverage ActionADE's implementation to conduct a randomized trial on patients diagnosed with adverse drug reactions in the main trial. This study will take place in Vancouver, British Columbia, Canada.

Conditions

Adverse Drug Event; Adverse Drug Reaction

Keywords

Health Information Technology; Patient Safety; Health Systems

Outcome Measures

Primary Outcomes (1)

• Culprit or same-class medication re-dispensing during follow-up

  The summary measure will be the proportion of patients with a culprit medication re-dispensation within 12 months. The effect measure will be the between-group difference in the proportion with a 12 month re-dispensation.

  12 months

Secondary Outcomes (3)

• Hospital visits

  12 months

• Hospital stay

  12 months

• Mortality

  12 months

Study Arms (2)

ADE information transmitted to PharmaNet

EXPERIMENTAL

Patients in the experimental arm will have standardized adverse drug event information documented in ActionADE transmitted to and stored in PharmaNet, British Columbia's medication dispensing database. The adverse drug event information will become visible to any subsequent healthcare provider who accesses the patient's PharmaNet profile. Community pharmacy software will import the adverse drug event information such that community pharmacists can view the adverse drug event information prior to dispensing medications.

Device: ActionADE

Standard care (ADE information retained locally)

NO INTERVENTION

Patients in the control group will have their adverse drug event information recorded in ActionADE, and their information will be retained locally, as is the current standard of care. This means that their adverse drug event information will not be visible to other providers via PharmaNet.

Interventions

ActionADE DEVICE

ActionADE is a software application that allows healthcare providers to document standardized adverse drug event information in a user-friendly and standardized manner. We integrated ActionADE uni-directionally with PharmaNet, a secure province-wide network that links all pharmacies in British Columbia to a central data system. This allows care providers to pull in demographic information and visualize their patient's medication dispensing history. In 2020, we enabled bi-directional integration with PharmaNet allowing clinicians to transmit standardized adverse drug event information back to the PharmaNet database. The three dominant community pharmacy systems in the geographic area of the trial will display the adverse drug event information in their systems, and generate patient-specific medication-level alerts when pharmacists attempt to re-dispense a culprit medication.

ADE information transmitted to PharmaNet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 19 years of age or older presenting to the participating emergency departments with an adverse drug reaction to a prescribed outpatient medication that was reported in ActionADE.

You may not qualify if:

• Patients whose adverse drug event is categorized as life threatening will be excluded.
• Patients without a Provincial Health Number will be excluded as this will prevent linkage with PharmaNet and other administrative data for outcomes ascertainment.
• Patients diagnosed with adverse drug events to culprit medications not on the provincial formulary will be excluded as we will not be able to ascertain re-dispensations outcomes for these medications using PharmaNet data.

Sponsors & Collaborators

• University of British Columbia: lead
• Ministry of Health, British Columbia: collaborator
• Vancouver Coastal Health: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (1)

• Hau JP, Brasher PMA, Cragg A, Small S, Wickham M, Hohl CM. Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial. Trials. 2021 Feb 5;22(1):119. doi: 10.1186/s13063-021-05061-7.

  PMID: 33546752 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Corinne M Hohl, MD, MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey P Hau, MSc

CONTACT

6048754111; jeffrey.hau@ubc.ca

Corinne M Hohl, MD,MSc

CONTACT

6048754111; corinne.hohl@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants, outcomes assessors, and study investigators will be blinded to treatment allocation. Community pharmacists cannot be blinded to the intervention, as we are studying the change in pharmacists' dispensing behavior due to the provision of new adverse drug event information. The information will only appear for patients in the experimental arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will conduct a triple-blind randomized controlled trials. We will enroll consecutive eligible patients presenting to the Emergency Department with an adverse drug event to prescribed outpatient medication. Randomization is implemented in the ActionADE application. Randomization will be equal (1:1) and stratified by site and age (\< 80, ≥ 80). A statistician otherwise uninvolved in the study will generate a list of treatment assignments using permuted blocks of varying sizes for each stratum. ActionADE will store the randomization list for each stratum. Once eligibility has been determined, the application will allocate the patient to the next available assignment within the stratum.

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 29, 2020
• Study Start: March 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2024
• Last Updated: November 20, 2020

Record last verified: 2020-11