Pharmaceutical Care in VA Nursing Home | NCT01823757

Studies
Pharmaceutical Care in VA Nursing Home

NCT01823757

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Aug 28, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Focus on the Elderly in a Nursing Home

Interventions

Pharmaceutical care

Countries

Taiwan

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

ID	Type	Description	Link
TCVGHPHARM_RESEARCH_1	Other Identifier	Taichung Veteran General Hospital

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jul 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Mar 29, 2013

First Submission Date that Met QC Criteria

Mar 29, 2013

First Posted Date

Apr 4, 2013Estimated

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

Aug 27, 2014

Last Update Posted Date

Aug 28, 2014Estimated

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

This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are:

After patients receive pharmaceutical care, their drug related problems will be decreased.
After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.

Detailed Description

Around 200 residents in a Veteran nursing home will be selected for reviewing inclusion and exclusion criteria. A total of 100 subjected are selected into this randomized controlled trial. Each group will have 50 subjects and then divides into 4 subgroup, according to their drug items used (5-7 and over 8 items used).

The inclusion criteria:

Residents of the Veteran nursing home.
over 65 years old.
complete comprehensive geriatric assessment (CGA)
prescription drugs more than 4 times/day, excluding stat order.
with 2 or more chronic diseases.

Exclusion criteria:

1. residents who were in the pharmaceutical care project of Taiwan Pharmacists Association.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-pharmaceutical care		Veterans do not receiving pharmaceutical care
Pharmaceutical care		Veterans receiving pharmaceutical care	Other: Pharmaceutical care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmaceutical care	Other	pharmacists provide pharmaceutical care to the intervention group, comparing to ordinary care in control group	Pharmaceutical care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
potential inappropriate medication (PIA)		one year

Secondary Outcomes

Measure	Description	Time Frame
drug items used	the controlled group is expected to have less drug items used.	one year
medical expenditure	subjects self-reported outpatients visit, hospitalization, drug, and healthy supplemental used.

Other Outcomes

Measure	Description	Time Frame
quality of life measure	use health outcome measure, EQ-5D, to assess the quality of life issue.	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Residents in the Veteran nursing home
Age over 65 years old
Complete Comprehensive Geriatric Assessment (CGA)
Use more than 4 drug item per day (excluding stat order)
subjects with more than 2 chronic diseases.

Exclusion Criteria:

subjects who were in pharmaceutical care project of Taiwan Pharmacist Association.

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

Resident from a Veteran nursing home and willing to receive the pharmaceutical care by pharmacists.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wen-Shyong Liou, PhD	Taichung Veteran General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhua Domiciliar Center		Changhua	Taiwan		Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D010593	Pharmaceutical Services

Ancestor Terms

ID	Term
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided