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CompletedNCT01118208BPUpdated Oct 20, 2017

Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

An interventional study of Blister packaging medications and Dispense as usual in Medication Adherence, Accidental Overdose and Deliberate Overdose, sponsored by VA Eastern Colorado Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by VA Eastern Colorado Health Care System · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
303
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Medication Adherence
  • Accidental Overdose
  • Deliberate Overdose
  • Suicide, Attempted

Keywords

  • Medication adherence
  • Accidental overdose
  • Deliberate overdose
  • Suicide, attempted
03

In context

Medication Adherence

937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.

This study's enrollment of 303 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.

Browse Medication Adherence studies →

Lead sponsor

VA Eastern Colorado Health Care System is the lead sponsor of 49 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
303 participants (actual)

Study arms

  • Experimental
    Blister Packaging

    Patients will receive all prescription medications on blister pack cards.

    Other: Blister packaging medications

  • Active comparator
    Dispense as Usual

    Patients will receive all prescription medications in standard pill bottles.

    Other: Dispense as usual

Interventions

  • OtherBlister packaging medications

    Dispensing prescription medications on pre-filled blister package cards.

    Also known as: Blister cards, bubble packs, unit-dose packaging.

  • OtherDispense as usual

    Dispensing prescription medications in standard pill bottles.

06

What researchers measure

Primary outcomes

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

    Time frame: monthly for 12 months

Secondary outcomes

  1. Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)

    Both accidental and intentional overdoses will be assessed.

    Time frame: monthly for 12 months

07

Study locations

1 site
  • Denver VA Medical Center
    Denver, Colorado 80220, United States
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References and documents

Publications

  • 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. PubMed 28961661 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01118208
Lead sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense
Responsible party
Peter M. Gutierrez (Clinical/Research Psychologist, VA Eastern Colorado Health Care System) — Principal investigator
First posted
May 6, 2010
Start date
Sep 2009
Primary completion
Jun 2014
Completion
Sep 2014
Last update
Oct 20, 2017

Study contacts

Peter M Gutierrez, Ph.D.
principal investigator · VA VISN 19 MIRECC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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