Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by McGill University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Robyn Tamblyn, McGill University
ClinicalTrials.gov Identifier:
NCT01179867
First received: August 10, 2010
Last updated: April 24, 2014
Last verified: April 2014
  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

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:

  1. 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
  2. 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
  3. 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.

  Show Detailed Description

  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, geriatric 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):
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: April 24, 2014
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

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2014