Blister Packaging Medication to Increase Treatment Adherence and Clinical Response (BP)

October 18, 2017 updated by: Peter M. Gutierrez, VA Eastern Colorado Health Care System

Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blister Packaging
Patients will receive all prescription medications on blister pack cards.
Other: Blister packaging medications
Dispensing prescription medications on pre-filled blister package cards.
Other Names:
  • Blister cards, bubble packs, unit-dose packaging.
Active Comparator: Dispense as Usual
Patients will receive all prescription medications in standard pill bottles.
Other: Dispense as usual
Dispensing prescription medications in standard pill bottles.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Eastern Colorado Health Care System

Collaborators

United States Department of Defense

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-09-1-0723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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