Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge - Full Text View

Purpose

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.

Condition	Intervention
Medication Reconciliation Adverse Drug Events	Other: Electronic Medication Reconciliation


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge

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MedlinePlus related topics: Health Facilities

U.S. FDA Resources

Further study details as provided by McGill University:

Primary Outcome Measures:

Adverse Drug Event [ Time Frame: 30 days after discharge from hospital ] [ Designated as safety issue: Yes ]
Adverse drug event: an injury resulting from medical intervention related to a drug.

Assessed using:
1. self-reported patient information 30 days post-discharge
2. chart and administrative data on drugs that were started, stopped, or continued at discharge as well as acute and chronic health problems
3. 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.

Secondary Outcome Measures:

Emergency Room Visit/Hospital Readmission [ Time Frame: within 30 days post-discharge ] [ Designated as safety issue: Yes ]
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.
Failure to re-start community medications used for chronic conditions after discharge from hospital. [ Time Frame: 90 days after discharge from hospital ] [ Designated as safety issue: Yes ]
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).
Readiness for hospital discharge [ Time Frame: Within the 30 days post-discharge from hospital ] [ Designated as safety issue: No ]
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.
Time to complete medication history and discharge medication reconciliation with prescription. [ Time Frame: At admission to study unit, and upon discharge from hospital. ] [ Designated as safety issue: No ]
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.
Therapy Duplication [ Time Frame: during the 30 days post discharge from hospital ] [ Designated as safety issue: Yes ]
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 dispensed to the same person within the 30 days post-discharge from hospital.


Estimated Enrollment:	3714
Study Start Date:	April 2014
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Electronic Medication Reconciliation	Other: Electronic Medication Reconciliation Electronic medication reconciliation includes: at admission the community drug list will be electronically retrieved from the public drug insurance administrative databases using a real-time interface, and the admitting team/pharmacist will verify the list, adding over-the-counter medications at discharge the attending physician/resident will write the discharge prescription using the discharge reconciliation module, allowing the physician to simultaneously view the validated community drug list and the hospital pharmacy drug list for the patient the discharge communication module will facilitate identification and transfer of information on discontinued and changed medication to the respective dispensing pharmacies and prescribing physicians along with the reasons for these changes
No Intervention: Usual practice medication reconciliation Usual practice in dealing with medication reconciliation. This includes viewing the hospital medications through the hospital electronic pharmacy system, and viewing the community drugs in the patient's chart, if it was collected at admission (not always the case). However not all physicians view the community drugs before writing the discharge prescription. The physician will write a paper discharge prescription to be given to the patient, but communications are generally not made directly to the community pharmacist or previous prescribing physicians.

Arms

Assigned Interventions

Experimental: Electronic Medication Reconciliation

Other: Electronic Medication Reconciliation

Electronic medication reconciliation includes:

at admission the community drug list will be electronically retrieved from the public drug insurance administrative databases using a real-time interface, and the admitting team/pharmacist will verify the list, adding over-the-counter medications
at discharge the attending physician/resident will write the discharge prescription using the discharge reconciliation module, allowing the physician to simultaneously view the validated community drug list and the hospital pharmacy drug list for the patient
the discharge communication module will facilitate identification and transfer of information on discontinued and changed medication to the respective dispensing pharmacies and prescribing physicians along with the reasons for these changes

No Intervention: Usual practice medication reconciliation

Usual practice in dealing with medication reconciliation. This includes viewing the hospital medications through the hospital electronic pharmacy system, and viewing the community drugs in the patient's chart, if it was collected at admission (not always the case). However not all physicians view the community drugs before writing the discharge prescription. The physician will write a paper discharge prescription to be given to the patient, but communications are generally not made directly to the community pharmacist or previous prescribing physicians.

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179867

Contacts


Contact: Robyn Tamblyn, PhD	514-934-1934 ext 32997	robyn.tamblyn@mcgill.ca
Contact: Jessica Nadigel, PhD	514-934-1934 ext 32981	jessica.nadigel@mcgill.ca

Locations


Canada, Quebec
McGill University Health Centre	Recruiting
Montreal, Quebec, Canada, H3A 1A3
Contact: Robyn Tamblyn, PhD 514-934-1934 ext 32997 robyn.tamblyn@mcgill.ca
Principal Investigator: Robyn Tamblyn, PhD

Sponsors and Collaborators

McGill University

Canadian Institutes of Health Research (CIHR)

Investigators


Principal Investigator:	Robyn Tamblyn, PhD	McGill University

More Information

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tamblyn R, Huang AR, Meguerditchian AN, Winslade NE, Rochefort C, Forster A, Eguale T, Buckeridge D, Jacques A, Naicker K, Reidel KE. Using novel Canadian resources to improve medication reconciliation at discharge: study protocol for a randomized controlled trial. Trials. 2012 Aug 27;13:150. doi: 10.1186/1745-6215-13-150.


Responsible Party:	Robyn Tamblyn, Professor, McGill University
ClinicalTrials.gov Identifier:	NCT01179867 History of Changes
Other Study ID Numbers:	RN 0000086616 - 222163
Study First Received:	August 10, 2010
Last Updated:	February 19, 2015
Health Authority:	United States: Dr. David Bates (Harvard University) United States: Dr. Gordie Schiff (Harvard University) Canada: Dr. Anne Holbrick (McMaster University)

Keywords provided by McGill University:


Medication reconciliation Adverse drug events Hospital readmission Medication management

ClinicalTrials.gov processed this record on March 03, 2015