Evaluating ActionADE on Adverse Drug Event Due to Non-Adherence

NCT04574648 | Unknown DMC

• 1 other identifier: H18-01332_1
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Repeat non-adherence to medications is a common cause of preventable adverse drug events. Health information technologies have the potential to improve information continuity. However, they rarely interoperate to ensure providers can view non-adherence information documented in other systems. The investigators designed ActionADE to enable rapid documentation of adverse drug events, including non-adherence, and communicate the 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 an adverse events due to non-adherence. This study will take place in Vancouver, British Columbia, Canada.

Conditions

Adverse Drug Event; Non-Adherence, Medication

Keywords

Health Information Technology; Patient Safety; Medication Safety; Health System

Outcome Measures

Primary Outcomes (1)

• Patient adherence to culprit medication

  We will define adherence as the dispensation of \>80% of prescribed medication doses within 12-months, based on the recorded medication dose and frequency, and the volume and dates of re-dispensations.

  12 months

Secondary Outcomes (3)

• Hospital visits

  12 months

• Hospital stays

  12 months

• Mortality

  12 months

Study Arms (2)

ADE information transmitted to PharmaNet

EXPERIMENTAL

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

Device: ActionADE

Standard care (ADE information retained locally)

NO INTERVENTION

Patients in the control arm will have their information recorded in ActionADE, and their information will be retained locally, as is the current standard of care. This means that their 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 and non-adherence 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 information back to the PharmaNet database. The three dominant community pharmacy systems in the geographic area of the trial will display non-adherence information in their systems.

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 event due to non-adherence to a prescribed outpatient medication that was reported in ActionADE.

You may not qualify if:

• Patients whose adverse 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; Medication Adherence

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

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 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 enrol consecutive eligible patients presenting to the emergency department with an adverse event due to non-adherence 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 4, 2020
• First Posted: October 5, 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