Adverse Drug Events Clinical Trial
Official title:
Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge
Verified date | August 2019 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4014 |
Est. completion date | August 2019 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - have public drug insurance: this includes all those 65 years and older in the province of Quebec, as well as those under 65 on social assistance or who do not have drug insurance available through their employer - admitted to the hospital from the community - admitted to a surgical or internal medicine unit - discharged alive Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse drug event | Adverse drug event: an injury resulting from medical intervention related to a drug. Assessed using: self-reported patient information 30 days post-discharge chart and administrative data on drugs that were started, stopped, or continued at discharge as well as acute and chronic health problems reviewing & adjudicating the presence of an adverse event and the probability of it being drug related by a blinded expert panel review of each patient's chart and post-discharge interview data using the Leape & Bates method, and the Naranjo criteria. |
Withing the 30 days post-discharge from hospital | |
Secondary | Emergency room visit / Hospital readmission | All visits to the emergency room and/or hospital re-admission in the 30 days post-discharge will be measured using the provincial health insurance administrative databases. This approach ensures that all ER visits and re-admissions are included, not just those occuring at the study hospitals. Almost all hospital-based physicians in Quebec are remunerated on a fee-for-service basis, and are required to record accurately the treating establishment and location of service, as this information determines the level of remuneration. | Within the 30 days post-discharge from hospital | |
Secondary | Failure to re-start community medications used for chronic conditions after discharge from hospital. | Of all discharged patients who were on a medication used for a chronic condition in the community prior to their hospitalization, we will measure the proportion who do not re-start this medication within the 90 days after they are discharged from hospital. This will be measured through comparison of their dispensed community medications before and after hospitalization (from administrative insurance database). | 90 days after discharge from hospital | |
Secondary | Readiness for hospital discharge | This sub-study will examine the determinants and outcomes of patients' readiness for hospital discharge. Specifically, it will determine if: a) patient and hospital organizational characteristics are associated with patients' readiness for hospital discharge, b) lower levels of patients' readiness for hospital discharge are associated with an increased risk of ADEs and re-admissions 30-day post-discharge and, c) the effects of the medication reconciliation intervention on ADEs and readmissions 30-day post discharge is modified by level of patient's readiness for hospital discharge. | Within the 30 days post-discharge from hospital | |
Secondary | Time to complete medication history and discharge medication reconciliation with prescription. | We will measure the time it takes clinicians to complete the patient's medication history at admission, which includes time spent speaking with patients about medications, contacting patients' pharmacies for information on patients' community medications, and documenting the community medication list. We will also measure the time it takes clinicians to complete a medication reconciliation at discharge and write the discharge prescription. We will compare the intervention and control groups, to see if the intervention reduces the time it takes clinicians to complete either of these two tasks. | At admission to study unit, and upon discharge from hospital | |
Secondary | Therapy duplication | We will measure the frequency at which therapy duplications occur in the discharge prescription, comparing intervention with control units. A therapy duplication will be defined as two or more drugs in the same therapeutic class being prescribed to the same patient. | Withing the 30 days post-discharge from hospital | |
Secondary | Unplanned dose changes | We will measure the frequency at which unplanned dose changes occur in the discharge prescription, comparing intervention with control units. An unplanned dose change will be defined as a change in dose from that at admission that was not documented as such in the discharge prescription. | Withing the 30 days post-discharge from hospital | |
Secondary | Errors of omission | We will measure the frequency at which errors of omission occur in the discharge prescription, comparing intervention with control units. An omission will be defined as a community medication (i.e. dispensed in the 3 months prior to admission) that is not present on the discharge prescription. | Withing the 30 days post-discharge from hospital |
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