Optimizing Medication Therapy for Patients Recently Discharged From Hospital
Primary Purpose
Chronic Disease
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist Consultation
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease
Eligibility Criteria
Inclusion Criteria:
- 50 years of age or older
- Admitted to a General Medicine ward
- Take 5 or more chronic medications
Exclusion Criteria:
- Discharge to a long term care facility
- Life expectancy less than 3 months
- Have entered palliative care
- Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
- Non-English speaking
- Unable to provide informed consent
Sites / Locations
- Health Sciences Center
- St. Clares Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacist Consultation
Control
Arm Description
Meet with pharmacist for consultation in addition to regular physician follow up
Receive regular physician follow up
Outcomes
Primary Outcome Measures
Composite Hospital Utilization Rate
A composite score of hospital readmission rate and ER visits
Secondary Outcome Measures
Number of Emergency Room Visits
Number of Emergency Room Visits
Number of Emergency Room Visits
Rehospitalization Rate
Rehospitalization Rate
Rehospitalization Rate
Mortality Rate
Mortality Rate
Mortality Rate
Frequency of Family Physician Visits
Frequency of Family Physician Visits
Frequency of Family Physician Visits
Full Information
NCT ID
NCT02888782
First Posted
August 25, 2016
Last Updated
October 4, 2018
Sponsor
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT02888782
Brief Title
Optimizing Medication Therapy for Patients Recently Discharged From Hospital
Official Title
Optimizing Medication Therapy Outcomes for Complex Patients Transitioning From Acute to Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Program Restructured
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients who are discharged from hospital can be overwhelmed when they suddenly have to manage new conditions or medications. These changes can be particularly difficult for people on many medications or with multiple health conditions. There is a real risk that this will lead to emergency room visits, hospital readmission, and even death. In addition to endangering patients, these adverse events are very costly to the healthcare system. The good news is that these events can be preventable if patients receive care that is better coordinated.
Patient-oriented research will be conducted to determine if a pharmacist-led medication therapy management service can improve health outcomes of 'medically complex' patients transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more comprehensive service than their community pharmacist would normally provide. The program will use a new Pharmacist Clinic service to provide care and support which does not currently exist for patients in NL after they leave hospital. After discharge, patients will be randomly divided into two groups: one group will receive care as usual from their doctor; the other group will have their medications assessed by a clinic pharmacist within one week of hospital discharge along with their usual care from their doctor. The two groups will be compared to determine whether specialized pharmacist services after hospital discharge is satisfactory to patients/providers, improves patient health, and reduces emergency room visits, hospital readmissions, and repeat trips to the doctor. If successful, this project will help ensure that patients are taking the right medications in the right way, improving individual health and making better use of healthcare system resources.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Consultation
Arm Type
Experimental
Arm Description
Meet with pharmacist for consultation in addition to regular physician follow up
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receive regular physician follow up
Intervention Type
Other
Intervention Name(s)
Pharmacist Consultation
Primary Outcome Measure Information:
Title
Composite Hospital Utilization Rate
Description
A composite score of hospital readmission rate and ER visits
Time Frame
30 days post discharge
Secondary Outcome Measure Information:
Title
Number of Emergency Room Visits
Time Frame
30 days post discharge
Title
Number of Emergency Room Visits
Time Frame
60 days post discharge
Title
Number of Emergency Room Visits
Time Frame
90 days post discharge
Title
Rehospitalization Rate
Time Frame
30 days post discharge
Title
Rehospitalization Rate
Time Frame
60 days post discharge
Title
Rehospitalization Rate
Time Frame
90 days post discharge
Title
Mortality Rate
Time Frame
30 days post discharge
Title
Mortality Rate
Time Frame
60 days post discharge
Title
Mortality Rate
Time Frame
90 days post discharge
Title
Frequency of Family Physician Visits
Time Frame
30 days post discharge
Title
Frequency of Family Physician Visits
Time Frame
60 days post discharge
Title
Frequency of Family Physician Visits
Time Frame
90 days post discharge
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction Survey
Description
Measured using a Likert scale questionnaire
Time Frame
Collected 3 - 6 months after study enrollment
Title
Pharmacist Satisfaction Survey
Description
Measured using a Likert scale questionnaire
Time Frame
Collected at the end of study period (12-15 months)
Title
Physician Satisfaction Survey
Description
Measured using a Likert scale questionnaire
Time Frame
Collected at the end of study period (12-15 months)
Title
Patient quality of life Short Form Health Survey
Description
Measured using a Short Form Health Survey (SF-36)
Time Frame
Collected at time of hospital discharge
Title
Patient quality of life Short Form Health Survey
Description
Measured using a Short Form Health Survey (SF-36)
Time Frame
Collected at 30, 60 and 90 days post hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50 years of age or older
Admitted to a General Medicine ward
Take 5 or more chronic medications
Exclusion Criteria:
Discharge to a long term care facility
Life expectancy less than 3 months
Have entered palliative care
Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
Non-English speaking
Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Kelly, PharmD
Organizational Affiliation
Memorial Univeristy of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Center
City
Saint John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
St. Clares Mercy Hospital
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Medication Therapy for Patients Recently Discharged From Hospital
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