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Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

NCT ID: NCT01118208

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Medication Adherence Accidental Overdose Deliberate Overdose Suicide, Attempted

Keywords

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Medication adherence Accidental overdose Deliberate overdose Suicide, attempted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Blister Packaging

Patients will receive all prescription medications on blister pack cards.

Group Type EXPERIMENTAL

Blister packaging medications

Intervention Type OTHER

Dispensing prescription medications on pre-filled blister package cards.

Dispense as Usual

Patients will receive all prescription medications in standard pill bottles.

Group Type ACTIVE_COMPARATOR

Dispense as usual

Intervention Type OTHER

Dispensing prescription medications in standard pill bottles.

Interventions

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Blister packaging medications

Dispensing prescription medications on pre-filled blister package cards.

Intervention Type OTHER

Dispense as usual

Dispensing prescription medications in standard pill bottles.

Intervention Type OTHER

Other Intervention Names

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Blister cards, bubble packs, unit-dose packaging.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Peter M. Gutierrez

Clinical/Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter M Gutierrez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA VISN 19 MIRECC

Locations

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Denver VA Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 28961661 (View on PubMed)

Other Identifiers

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W81XWH-09-1-0723

Identifier Type: -

Identifier Source: org_study_id