Optimizing Medication Therapy for Patients Recently Discharged From Hospital

Optimizing Medication Therapy Outcomes for Complex Patients Transitioning From Acute to Primary Care

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Pharmacist Consultation

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada
      • Health Sciences Center
    • St. John's, Newfoundland and Labrador, Canada
      • St. Clares Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 50 years of age or older
2. Admitted to a General Medicine ward
3. Take 5 or more chronic medications

Exclusion Criteria:

1. Discharge to a long term care facility
2. Life expectancy less than 3 months
3. Have entered palliative care
4. Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
5. Non-English speaking
6. Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist Consultation; Meet with pharmacist for consultation in addition to regular physician follow up	Other: Pharmacist Consultation
No Intervention: Control; Receive regular physician follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Hospital Utilization Rate	A composite score of hospital readmission rate and ER visits	30 days post discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Emergency Room Visits	30 days post discharge
Number of Emergency Room Visits	60 days post discharge
Number of Emergency Room Visits	90 days post discharge
Rehospitalization Rate	30 days post discharge
Rehospitalization Rate	60 days post discharge
Rehospitalization Rate	90 days post discharge
Mortality Rate	30 days post discharge
Mortality Rate	60 days post discharge
Mortality Rate	90 days post discharge
Frequency of Family Physician Visits	30 days post discharge
Frequency of Family Physician Visits	60 days post discharge
Frequency of Family Physician Visits	90 days post discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Survey	Measured using a Likert scale questionnaire	Collected 3 - 6 months after study enrollment
Pharmacist Satisfaction Survey	Measured using a Likert scale questionnaire	Collected at the end of study period (12-15 months)
Physician Satisfaction Survey	Measured using a Likert scale questionnaire	Collected at the end of study period (12-15 months)
Patient quality of life Short Form Health Survey	Measured using a Short Form Health Survey (SF-36)	Collected at time of hospital discharge
Patient quality of life Short Form Health Survey	Measured using a Short Form Health Survey (SF-36)	Collected at 30, 60 and 90 days post hospital discharge

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland
• Investigators: Principal Investigator: Deborah Kelly, PharmD, Memorial Univeristy of Newfoundland

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: HREB-2016.221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No