NCT02888782

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

August 25, 2016

Last Update Submit

October 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite Hospital Utilization Rate

    A composite score of hospital readmission rate and ER visits

    30 days post discharge

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Other Outcomes (5)

  • Patient Satisfaction Survey

    Collected 3 - 6 months after study enrollment

  • Pharmacist Satisfaction Survey

    Collected at the end of study period (12-15 months)

  • Physician Satisfaction Survey

    Collected at the end of study period (12-15 months)

  • +2 more other outcomes

Study Arms (2)

Pharmacist Consultation

EXPERIMENTAL

Meet with pharmacist for consultation in addition to regular physician follow up

Other: Pharmacist Consultation

Control

NO INTERVENTION

Receive regular physician follow up

Interventions

Pharmacist Consultation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Admitted to a General Medicine ward
  • Take 5 or more chronic medications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Sciences Center

St. John's, Newfoundland and Labrador, Canada

Location

St. Clares Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Deborah Kelly, PharmD

    Memorial Univeristy of Newfoundland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Special Advisor of Innovation

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 5, 2016

Study Start

December 8, 2016

Primary Completion

April 30, 2018

Study Completion

June 29, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations