Blister Packaging Medication to Increase Treatment Adhere... | NCT01118208

Studies
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

NCT01118208

Sponsor

VA Eastern Colorado Health Care System

Status

Completed

Last Update Posted

Oct 20, 2017Actual

Enrollment

303Actual

Phase

Not Applicable

Conditions

Medication Adherence
Accidental Overdose
Deliberate Overdose
Suicide, Attempted

Interventions

Blister packaging medications
Dispense as usual

Countries

United States

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 2017

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

Sep 2009

Primary Completion Date

Jun 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 4, 2010

First Submission Date that Met QC Criteria

May 4, 2010

First Posted Date

May 6, 2010Estimated

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 18, 2017

Last Update Posted Date

Oct 20, 2017Actual

Name	Class
United States Department of Defense	FED

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 quantitative, interview-based study will determine if increased prescription medication adherence via blister pack administration will reduce suicide related behavior among the high risk population of patients discharged from a psychiatric inpatient unit. The aims of the project are to determine whether blister packaging medication significantly increases treatment adherence and if blister packaging significantly decreases intentional self-poisoning behavior (i.e., suicide attempts and completions). By tracking former psychiatric inpatients for 12 months post-discharge and obtaining monthly medication adherence ratings, we will determine if blister packaging (BP) medications leads to better adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report and medical record review) of suicide-related behaviors, we will determine if patients in the BP condition have less intentional self-poisoning behavior than those in the DAU condition.

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

303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blister Packaging	Experimental	Patients will receive all prescription medications on blister pack cards.	Other: Blister packaging medications
Dispense as Usual	Active Comparator	Patients will receive all prescription medications in standard pill bottles.	Other: Dispense as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blister packaging medications	Other	Dispensing prescription medications on pre-filled blister package cards.	Blister Packaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)		monthly for 12 months

Secondary Outcomes

Measure	Description	Time Frame
Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)	Both accidental and intentional overdoses will be assessed.	monthly for 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 or older
diagnosed with major affective disorder,
bipolar affective disorder,
post-traumatic stress disorder, or
schizophrenia (or any combination of these diagnoses)
under voluntary status at some point during admission
currently prescribed medications
deemed capable of managing their own medications after discharge
not currently active duty in any branch of the military
able to correctly answer questions verifying they understand the consent form
English-Speaking

Exclusion Criteria:

Under the age of 18
Not under voluntary status at some point during admission
Not currently prescribed medications
Not able to manage their own medications after discharge
Non-English-speaking
Currently active duty in any branch of the military
Inability to correctly answer questions indicating comprehension of information on the consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Peter M Gutierrez, Ph.D.	VA VISN 19 MIRECC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver VA Medical Center		Denver	Colorado	80220	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28961661	Result	Gutierrez PM, Wortzel HS, Forster JE, Leitner RA, Hostetter TA, Brenner LA. Blister Packaging Medication Increases Treatment Adherence in Psychiatric Patients. J Psychiatr Pract. 2017 Sep;23(5):320-327. doi: 10.1097/PRA.0000000000000252.

ID	Term
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

ID	Term
D055118	Medication Adherence
D013406	Suicide, Attempted