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

Primary Purpose

Medication Adherence, Accidental Overdose, Deliberate Overdose

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blister packaging medications
Dispense as usual
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Adherence focused on measuring Medication adherence, Accidental overdose, Deliberate overdose, Suicide, attempted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blister Packaging

Dispense as Usual

Arm Description

Patients will receive all prescription medications on blister pack cards.

Patients will receive all prescription medications in standard pill bottles.

Outcomes

Primary Outcome Measures

Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)

Secondary Outcome Measures

Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)
Both accidental and intentional overdoses will be assessed.

Full Information

First Posted
May 4, 2010
Last Updated
October 18, 2017
Sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01118208
Brief Title
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response
Acronym
BP
Official Title
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Accidental Overdose, Deliberate Overdose, Suicide, Attempted
Keywords
Medication adherence, Accidental overdose, Deliberate overdose, Suicide, attempted

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blister Packaging
Arm Type
Experimental
Arm Description
Patients will receive all prescription medications on blister pack cards.
Arm Title
Dispense as Usual
Arm Type
Active Comparator
Arm Description
Patients will receive all prescription medications in standard pill bottles.
Intervention Type
Other
Intervention Name(s)
Blister packaging medications
Other Intervention Name(s)
Blister cards, bubble packs, unit-dose packaging.
Intervention Description
Dispensing prescription medications on pre-filled blister package cards.
Intervention Type
Other
Intervention Name(s)
Dispense as usual
Intervention Description
Dispensing prescription medications in standard pill bottles.
Primary Outcome Measure Information:
Title
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)
Time Frame
monthly for 12 months
Secondary Outcome Measure Information:
Title
Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)
Description
Both accidental and intentional overdoses will be assessed.
Time Frame
monthly for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Gutierrez, Ph.D.
Organizational Affiliation
VA VISN 19 MIRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28961661
Citation
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.
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Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

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