Optimizing Medication Therapy for Patients Recently Disch... | NCT02888782

Studies
Optimizing Medication Therapy for Patients Recently Discharged From Hospital

NCT02888782

Sponsor

Memorial University of Newfoundland

Status

Terminated

Last Update Posted

Oct 9, 2018Actual

Enrollment

89Actual

Phase

Not Applicable

Conditions

Chronic Disease

Interventions

Pharmacist Consultation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Program Restructured

Expanded Access Info

Start Date

Dec 8, 2016Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Jun 29, 2018Actual

First Submitted Date

Aug 25, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2018

Last Update Posted Date

Oct 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deborah Kelly, Associate Professor and Special Advisor of Innovation, Memorial University of NewfoundlandPrincipal Investigator

Lead Sponsor

Memorial University of NewfoundlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pharmacist Consultation	Other		Pharmacist Consultation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah Kelly, PharmD	Memorial Univeristy of Newfoundland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences Center		St. John's	Newfoundland and Labrador		Canada
St. Clares Mercy Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002908	Chronic Disease

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided