Adverse Drug Events Clinical Trial
Official title:
Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge
The purpose of this study is to determine if a physician's use of electronic medication reconciliation software when writing a patient's discharge prescription will prevent adverse drug events and readmissions to the hospital. This electronic medication software will provide the physician with the most up-to-date list of medications the patient was taking before being admitted to the hospital, through a real-time link to the provincial drug insurance agency's administrative databases. It will also provide the list of medications the patient has taken while admitted to the hospital. With these two pieces of information, the physician will write the discharge prescription using the medication management software, print the discharge prescription for the patient, and the software will fax a copy of any prescriptions that should be stopped to the patient's community pharmacist.
Background:
- Drug-related illness accounts for 5-23% of hospital admissions, 4-8% of ambulatory
visits, and is now claimed to be the 6th leading cause of mortality.
- At least 58% of adverse drug events (ADEs) are considered preventable.
- Transitions in care, particularly between community and hospital, account for a
substantial number of preventable ADEs. In fact, between 12% to 17% of patients will
have an adverse drug event within 30 days of discharge from hospital, and 14.3% will be
readmitted.
- A major contributor to preventable ADEs is the failure to reconcile pre-admission
medications with drugs prescribed at discharge. To avoid preventable ADEs, medication
reconciliation is now a required organizational practice for hospital accreditation in
Canada and the United States.
- However, there are substantial challenges in implementing medication reconciliation, as
87% of patients do not know what drugs they are taking, and 63% of the time staff cannot
access outside records from the community pharmacy or primary care physician. As a
result, 60-70% of medication histories contain at least one error.
- The time and resources required to obtain the community drug profile far outstrips the
capacity to deliver this essential service for most patients.
Goal:
- Providing the medical team with the capacity to electronically retrieve the most
up-to-date community drug list from all pharmacies will optimize the accuracy of
medication histories and reduce the time required to reconcile the community and
hospital drug lists at discharge.
- This strategy will also identify and advise the community pharmacies and physicians of
the changes made during hospitalization, so that prescriptions for drugs that are
discontinued because of adverse effects or ineffective treatment do not continue to be
filled.
Preliminary work & novel opportunities:
- We established a "real-time" linkage to the Quebec health insurance agency (RAMQ) to
test the benefits of accessing the complete drug profile in primary care. In a pilot
test, we showed that the use of this linkage to retrieve community drug profiles at
admission identified 2 additional drugs per patient, and reduced medication
history-taking by 2.5 minutes per patient.
- There are unique opportunities to use existing drug insurance data to electronically
access the community drug profile in Quebec. The province currently maintains
comprehensive records of all dispensed medication for those insured through provincial
drug program, providing information on 97.6% of medication used in the community.
Scientific objectives:
To determine if electronically facilitated reconciliation of community and hospital drugs at
discharge and communication of treatment changes to the community-based prescribing
physicians and pharmacists will reduce the risk of ADEs and re-admissions in the 30 days
post-discharge.
Design:
A cluster randomized controlled trial will be used to evaluate the effects of electronic
discharge reconciliation and communication on the occurrence of ADEs post-discharge. The
study will be conducted at the McGill University Health Centre. We will stratify by medical
and surgical unit, and then randomize the units into discharge medication reconciliation or
usual care.
The discharge reconciliation intervention has three components:
1. at admission, the community drug profile will be retrieved from RAMQ and the data will
be transmitted to the hospital pharmacy information system;
2. at discharge, the physician will use a community / hospital reconciliation module to
write discharge prescriptions, discontinuation orders, and a rationale for all modified
community medications;
3. The updated medication list will be transmitted to the community-based prescribing
physician(s), and dispensing pharmacy(ies) by fax.
Usual care typically includes a community drug history by the admission team when feasible,
review by hospital pharmacist at the request of the treatment team, and manual reconciliation
of community and hospital drug lists on the discharge prescription performed at the
discretion of the discharging team.
The primary outcome will be ADEs, measured by follow-up interview 30 days post-discharge, and
the secondary outcome—re-admission/ ER visit in 30 days, assessed by retrieving complete
service utilization files from the RAMQ. Multivariate logistic regression will be used to
assess the impact of discharge medication reconciliation. For both the primary and secondary
outcome, we will assess whether adjustment for co-interventions and baseline differences
between patients in the usual care and intervention arm confound the effect of the
intervention. In a secondary analysis, we will assess whether the effect of the intervention
is modified by hospital unit type (medicine versus surgery) or patient characteristics that
are associated with a higher risk of adverse events (age, number of medications at discharge,
number of medication changes at discharge) by including respective interaction terms in the
logistic model and testing their significance using the Wald chi-square statistic.
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