Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-27 @ 9:51 AM
Study NCT ID:
NCT01179867
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2010-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge
Sponsor:
McGill University
Organization:
Study Overview
Official Title:
Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: