Clinical trial NCT04574648: Evaluating ActionADE on Adverse Drug Event Due to Non-Adherence
Official title: Implementing and Evaluating ActionADE to Transform Medication Safety Among Patients With an Adverse Drug Event Due to Non-Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Drug Event
Non-Adherence, Medication
Keywords: Health Information Technology
Patient Safety
Medication Safety
Health System
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, British Columbia
name: Vancouver Coastal Health
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-10-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Medication use is rising due to an aging population and expanding treatment indications for chronic diseases. Simultaneously, adverse drug events-harmful and unintended events related to medication use or misuse-have increased. In Canada, adverse events to outpatient medications cause over two million emergency department visits and 700,000 hospital admissions, costing over $1 billion in healthcare expenditures annually. Optimizing the benefits of medications while limiting their potential for harm is a public health priority across patient populations, health settings and medical disciplines.

The second most common subset of adverse events to outpatient medications was caused by non-adherence. Non-adherence has been associated with increased downstream health services utilization and costs of care, likely reflective of worse patient outcomes. It is unknown to what extent communication about non-adherence to outpatient medications can assist the care team in reinforcing patient adherence.

Patients with adverse events due to non-adherence often seek care in hospitals due to the unexpected and serious nature of these events. After assessment and treatment, patients are discharged back into the care of a community-based provider who often cannot access the hospital's medical record, may not receive a legible or detailed discharge summary. Therefore, community-based care providers risk managing the patient without knowing about the patient's non-adherence, and inappropriately up-titrating medication doses, or simply missing an opportunity to emphasize the importance of adherence.

The investigators developed ActionADE to address this type of information discontinuity. ActionADE was integrated to a province-wide network that links all pharmacies in British Columbia to a central data system, allowing users to see their patient's medication dispensing history.

The investigators will conduct a triple-blind randomized controlled trial to evaluate the effectiveness of ActionADE on preventing subsequent non-adherence. The trial will take place in two urban tertiary care (Vancouver General and Saint Paul's Hospitals) and one urban community hospital (Lions Gate Hospital) within the Greater Vancouver area, in British Columbia, Canada. Other hospitals may be added to accelerate recruitment into the trial if approved by the British Columbia Ministry of Health.

The primary objective of the trial is to evaluate the effect of providing information continuity about non-adherence using ActionADE on adherence over 12 months compared to standard care. Secondary objectives for both trials are to evaluate the effect on outpatient and emergency department visits, admissions, hospital-days and mortality.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patient adherence to culprit medication
timeFrame: 12 months
Secondary outcomes:
measure: Hospital visits
timeFrame: 12 months
measure: Hospital stays
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Corinne M Hohl, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.