CClinicalTrials.gg
CompletedNCT01164137CMRUpdated Feb 15, 2013Results posted

Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care

An interventional study of Medication Reconciliation in Adverse Drug Events, sponsored by Westview Physician Collaborative. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Westview Physician Collaborative · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital discharge.

Read the detailed description

The goals of this initiative are to decrease the risk for medication errors at the hospital community interface of care, thus decreasing preventable adverse drug events and preventable drug-related health system utilization following hospital discharge. This initiative has four objectives that aim to:

  1. Develop and test a community-based medication reconciliation process/intervention.
  2. Design and conduct a randomized controlled trial to examine the impact of the intervention on post-discharge health services utilization by comparing a set of outcome variables between intervention and non-intervention groups.
  3. Design a risk prediction model that helps identify patients discharged from in-patient care with the highest level of need for the intervention.
  4. Determine whether a community-based medication reconciliation process/intervention adds risk reduction value to individuals who have undergone an in-hospital medication reconciliation.
02

Conditions studied

  • Adverse Drug Events

Keywords

  • Adverse Drug Events
  • Medication Reconciliation
  • Pharmacist-led Intervention
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's enrollment of 156 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

This is the only study on the registry with Westview Physician Collaborative as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge.

Exclusion criteria

Exclusion Criteria:

  • First Nations persons
  • Residents of continuing care or assisted living facilities
  • Persons not residing in the Edmonton, AB, Canada region
  • Persons who obtain a score of 19 or less on the Mini Mental State Examination (MMSE)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    Medication Reconciliation Intervention

    Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.

    Behavioral: Medication Reconciliation

  • No intervention
    Medication Reconciliation Non-Interven.

    Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at identifying and correcting medication discrepancies.

Interventions

  • BehavioralMedication Reconciliation

    A pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.

06

What researchers measure

Primary outcomes

  1. Health Services Utilization 3 Months Following Hospital Discharge

    Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

    Time frame: 3 Months

  2. Health Services Utilization 6 Months Following Hospital Discharge

    Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

    Time frame: 6 Months

  3. Health Services Utilization 9 Months Following Hospital Discharge

    Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

    Time frame: 9 Months

  4. Health Services Utilization 12 Months Following Hospital Discharge

    Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

    Time frame: 12 months

  5. Health Services Utilization 18 Months Following Hospital Discharge

    Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

    Time frame: 18 months

07

Results

Posted Jan 30, 2013

Participant flow

Recruitment period began November 1, 2008 and ended June 30, 2010.

Participant flow — Overall Study
MilestoneExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Started8076
Completed7776
Not completed30

Outcome measures

PrimaryHealth Services Utilization 3 Months Following Hospital Discharge

Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Time frame:
3 Months
Reported as:
Mean · Health Services Utilizations
Health Services Utilization 3 Months Following Hospital Discharge
Health Services UtilizationsExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Health Services Utilization 3 Months Following Hospital Discharge3.33 ± .353.40 ± .29
Statistical analysis
  • Experimental: Medication Reconciliation Intervention vs Control: Medication Reconciliation Non-Intervention · t-test, 2 sided · p = .87 · Mean difference (final values): -.07 · 95% CI -.98 to .84
PrimaryHealth Services Utilization 6 Months Following Hospital Discharge

Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Time frame:
6 Months
Reported as:
Mean · Health Services Utilizations
Health Services Utilization 6 Months Following Hospital Discharge
Health Services UtilizationsExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Health Services Utilization 6 Months Following Hospital Discharge4.57 ± .523.93 ± .35
Statistical analysis
  • Experimental: Medication Reconciliation Intervention vs Control: Medication Reconciliation Non-Intervention · t-test, 2 sided · p = .32 · Mean difference (final values): .63 · 95% CI -.62 to 1.88
PrimaryHealth Services Utilization 9 Months Following Hospital Discharge

Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Time frame:
9 Months
Reported as:
Mean · Health Services Utilizations
Health Services Utilization 9 Months Following Hospital Discharge
Health Services UtilizationsExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Health Services Utilization 9 Months Following Hospital Discharge5.71 ± .804.49 ± .41
Statistical analysis
  • Experimental: Medication Reconciliation Intervention vs Control: Medication Reconciliation Non-Intervention · t-test, 2 sided · p = .18 · Mean difference (final values): 1.21 · 95% CI -.57 to 3.01
PrimaryHealth Services Utilization 12 Months Following Hospital Discharge

Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Time frame:
12 months
Reported as:
Mean · Health Services Utilizations
Health Services Utilization 12 Months Following Hospital Discharge
Health Services UtilizationsExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Health Services Utilization 12 Months Following Hospital Discharge6.74 ± .945.03 ± .48
Statistical analysis
  • Experimental: Medication Reconciliation Intervention vs Control: Medication Reconciliation Non-Intervention · t-test, 2 sided · p = .11 · Mean difference (final values): 1.71 · 95% CI -.39 to 3.81
PrimaryHealth Services Utilization 18 Months Following Hospital Discharge

Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.

Time frame:
18 months
Reported as:
Mean · Health Services Utilizations
Health Services Utilization 18 Months Following Hospital Discharge
Health Services UtilizationsExperimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-Intervention
Health Services Utilization 18 Months Following Hospital Discharge7.80 ± 1.065.95 ± .59
Statistical analysis
  • Experimental: Medication Reconciliation Intervention vs Control: Medication Reconciliation Non-Intervention · t-test, 2 sided · p = .13 · Mean difference (final values): 1.85 · 95% CI -.56 to 4.27

Adverse events

Collected over 1 year, 7 months (i.e., November 1, 2008 to June 30, 2010). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental: Medication Reconciliation Intervention—0/80 (0%)0/80 (0%)
Control: Medication Reconciliation Non-Intervention—0/76 (0%)0/76 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-InterventionTotal
<=18 years000
Between 18 and 65 years341650
>=65 years4660106
Age Continuous
Age Continuous(years)Experimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-InterventionTotal
Mean68.40 ± 14.7072.59 ± 13.2770.48 ± 14.12
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-InterventionTotal
Female413374
Male394382
Region of Enrollment
Region of Enrollment(participants)Experimental: Medication Reconciliation InterventionControl: Medication Reconciliation Non-InterventionTotal
Canada8076156
08

Study locations

1 site
  • WestView Health Centre
    Stony Plain, Alberta T7Z 2M7, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01164137
Lead sponsor
Westview Physician Collaborative
Responsible party
Sponsor
First posted
Jul 16, 2010
Start date
Nov 2008
Primary completion
Feb 2013
Completion
Feb 2013
Results posted
Jan 30, 2013
Last update
Feb 15, 2013

Study contacts

Allan Bailey, M.D.
principal investigator · Westview Physician Collaborative
Grace Moe, M.Sc.P.T.
study director · WestView Primary Care Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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