Adverse Drug EventNCT04568668
Evaluating ActionADE in Reducing Adverse Drug Reactions
A study testing ActionADE in people with Adverse Drug Event and Adverse Drug Reaction, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adverse Drug Event, Adverse Drug Reaction
- What is being tested?
- ActionADE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementing and Evaluating ActionADE to Transform Medication Safety Among Patients With Adverse Drug Reactions
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.
Read the 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.
Patients with adverse drug events 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, and is at risk of either re-starting the culprit medication for chronic disease management in the case of an adverse drug reaction. 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 adverse drug reactions. 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 main trial is to evaluate the effect of providing information continuity about adverse drug reactions using ActionADE on culprit drug re-dispensations over 12 months compared to standard care. Secondary objectives are to evaluate the effect on outpatient and emergency department visits, admissions, hospital-days and mortality.
- Conditions
- Adverse Drug Event, Adverse Drug Reaction
- Being tested
- ActionADE
- Keywords
- Health Information Technology, Patient Safety, Health Systems
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActionADEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Hospital visits
Number of outpatient and emergency visits
Measured: 12 months
Hospital stay
Number of hospital-days during hospital admissions.
Measured: 12 months
Mortality
Number of all cause mortality during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, British Columbia, Vancouver Coastal Health, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Corinne Hohl, University of British Columbia
- Investigators
- Corinne M Hohl, MD, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568668
- Sponsor's protocol ID
- H18-01332
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33546752
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating ActionADE to Transform Medication Safety Among Patients With Adverse Drug Reactions
- ClinicalTrials.gov ID
- NCT04568668
- Acronym / sponsor ID
- H18-01332
- Conditions
- Adverse Drug Event, Adverse Drug Reaction
- Keywords
- Health Information Technology, Patient Safety, Health Systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia, Vancouver Coastal Health, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Patients with adverse drug events 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, and is at risk of either re-starting the culprit medication for chronic disease management in the case of an adverse drug reaction. 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 adverse drug reactions. 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 main trial is to evaluate the effect of providing information continuity about adverse drug reactions using ActionADE on culprit drug re-dispensations over 12 months compared to standard care. Secondary objectives are to evaluate the effect on outpatient and emergency department visits, admissions, hospital-days and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADE information transmitted to PharmaNet | Experimental | Device: ActionADEPatients 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActionADEActionADE 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. | Device | ADE information transmitted to PharmaNet |
Primary outcome
Culprit or same-class medication re-dispensing during follow-up
Time frame: 12 months
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.
3 secondary outcomes
Hospital visits
Time frame: 12 months
Hospital stay
Time frame: 12 months
Mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 33546752Hau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne M Hohl, MD, MSc principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing ActionADE in people with Adverse Drug Event and Adverse Drug Reaction, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey P Hau, MSc (6048754111 ext. 62270, jeffrey.hau@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culprit or same-class medication re-dispensing during follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.