Deprescribing in a Long Term Care Facility | NCT03091153

Studies
Deprescribing in a Long Term Care Facility

NCT03091153

Sponsor

Memorial University of Newfoundland

Status

Completed

Last Update Posted

Jul 22, 2019Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Polypharmacy

Interventions

Medication Review

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

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

Jul 19, 2019

Last Update Posted Date

Jul 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deborah Kelly, Associate Professor, Memorial University of NewfoundlandPrincipal Investigator

Lead Sponsor

Memorial University of NewfoundlandOTHER

Collaborators

Name	Class
Eastern Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. For this study, eligible residents will be randomized to receive either a deprescribing focused medication review or usual care.

The deprescribing focused medication therapy assessments will be done on half of the 143 residents residing on the second and third floors of the facility. The other half of residents will serve as the control group and continue to receive their annual medication review and regular care from the attending physicians and nurses.

The deprescribing intervention will be delivered by final year pharmacy students completing their practice experiences, under the supervision of clinical pharmacists at the LTC facility and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic. Currently the clinic has a well developed procedure for providing in depth medication therapy reviews for residents of the community, upon referral by their primary care physician. Students will adapt this model of medication review to have a stronger deprescribing focus and be applicable to elderly residents of a LTC facility. The intervention will consist of an in depth medication therapy review with a focus on identifying any medications that may no longer be required or are deemed to be inappropriate or potentially unsafe in the elderly based on currently guidelines/criteria. The students will work closely with members of the resident's care team on a daily basis, as well as the resident and their family, to develop and implement a deprescribing plan.

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

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Standard care. Annual medication review
Intervention	Experimental	In depth medication review with a focus on deprescribing	Other: Medication Review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medication Review	Other	In depth medication review with a focus on deprescribing	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in number of medications taken daily by residents	Measured using facility medication logs and patient health records	3 and 6 months after receiving intervention

Secondary Outcomes

Measure	Description	Time Frame
All cause mortality rate	Measured using patient health records	3 and 6 months after receiving the intervention
Instance of falls in the last 30 days	Measured using facility fall report logs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (all of the following):

Over 65 years of age
Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)

Exclusion Criteria (any of the following):

Do not take any regularly scheduled medications
Are receiving palliative care
Resident's physician or nursing team do not support participation
Resident or their substitute decision maker decline participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older 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 University of Newfoundland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Patrick's Mercy Home		St. John's	Newfoundland and Labrador		Canada

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

Intervention Browse Module

MeSH Terms

ID	Term
D000090143	Medication Review

Ancestor Terms

ID	Term
D008509	Medication Systems
D009934	Organization and Administration
D006298	Health Services Administration
D010346	Patient Care Management

Browse Leaves

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Browse Branches

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