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

Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care: to Develop and Test a Community-based Medication Reconciliation Program and a Risk Prediction Model That Identifies High-risk Patient Groups

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164137
Acronym
CMR
Enrollment
156
Registered
2010-07-16
Start date
2008-11-30
Completion date
2013-02-28
Last updated
2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Events

Keywords

Adverse Drug Events, Medication Reconciliation, Pharmacist-led Intervention

Brief 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.

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.

Interventions

BEHAVIORALMedication Reconciliation

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

Sponsors

Westview Physician Collaborative
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Health Services Utilization 3 Months Following Hospital Discharge3 MonthsMean 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.
Health Services Utilization 6 Months Following Hospital Discharge6 MonthsMean 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.
Health Services Utilization 9 Months Following Hospital Discharge9 MonthsMean 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.
Health Services Utilization 12 Months Following Hospital Discharge12 monthsMean 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.
Health Services Utilization 18 Months Following Hospital Discharge18 monthsMean 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.

Countries

Canada

Participant flow

Recruitment details

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

Pre-assignment details

Three participants were excluded from the trail before assignment to groups because they obtained a score of 19 or less on the Mini Mental State Examination (MMSE).

Participants by arm

ArmCount
Experimental: Medication Reconciliation Intervention
Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
80
Control: Medication Reconciliation Non-Intervention
Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
76
Total156

Baseline characteristics

CharacteristicControl: Medication Reconciliation Non-InterventionExperimental: Medication Reconciliation InterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
60 Participants46 Participants106 Participants
Age, Categorical
Between 18 and 65 years
16 Participants34 Participants50 Participants
Age Continuous72.59 years
STANDARD_DEVIATION 13.27
68.40 years
STANDARD_DEVIATION 14.7
70.48 years
STANDARD_DEVIATION 14.12
Region of Enrollment
Canada
76 participants80 participants156 participants
Sex: Female, Male
Female
33 Participants41 Participants74 Participants
Sex: Female, Male
Male
43 Participants39 Participants82 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 800 / 76
serious
Total, serious adverse events
0 / 800 / 76

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Experimental: Medication Reconciliation InterventionHealth Services Utilization 12 Months Following Hospital Discharge6.74 Health Services UtilizationsStandard Error 0.94
Control: Medication Reconciliation Non-InterventionHealth Services Utilization 12 Months Following Hospital Discharge5.03 Health Services UtilizationsStandard Error 0.48
p-value: 0.1195% CI: [-0.39, 3.81]t-test, 2 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
Experimental: Medication Reconciliation InterventionHealth Services Utilization 18 Months Following Hospital Discharge7.80 Health Services UtilizationsStandard Error 1.06
Control: Medication Reconciliation Non-InterventionHealth Services Utilization 18 Months Following Hospital Discharge5.95 Health Services UtilizationsStandard Error 0.59
p-value: 0.1395% CI: [-0.56, 4.27]t-test, 2 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
Experimental: Medication Reconciliation InterventionHealth Services Utilization 3 Months Following Hospital Discharge3.33 Health Services UtilizationsStandard Error 0.35
Control: Medication Reconciliation Non-InterventionHealth Services Utilization 3 Months Following Hospital Discharge3.40 Health Services UtilizationsStandard Error 0.29
p-value: 0.8795% CI: [-0.98, 0.84]t-test, 2 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
Experimental: Medication Reconciliation InterventionHealth Services Utilization 6 Months Following Hospital Discharge4.57 Health Services UtilizationsStandard Error 0.52
Control: Medication Reconciliation Non-InterventionHealth Services Utilization 6 Months Following Hospital Discharge3.93 Health Services UtilizationsStandard Error 0.35
p-value: 0.3295% CI: [-0.62, 1.88]t-test, 2 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
Experimental: Medication Reconciliation InterventionHealth Services Utilization 9 Months Following Hospital Discharge5.71 Health Services UtilizationsStandard Error 0.8
Control: Medication Reconciliation Non-InterventionHealth Services Utilization 9 Months Following Hospital Discharge4.49 Health Services UtilizationsStandard Error 0.41
p-value: 0.1895% CI: [-0.57, 3.01]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026