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Completed

NCT Number: NCT01118208

Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

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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Key information

Conditions

Medication Adherence Accidental Overdose Behavior Behavioral Symptoms Deliberate Overdose Health Behavior Patient Acceptance of Health Care Patient Compliance Self-Injurious Behavior Suicide Suicide, Attempted Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blister packaging medications

Other

Dispensing prescription medications on pre-filled blister package cards.

Other names: Blister cards, bubble packs, unit-dose packaging.

Dispense as usual

Other

Dispensing prescription medications in standard pill bottles.

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)

    Time frame: monthly for 12 months

    Both accidental and intentional overdoses will be assessed.

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: BP

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 6, 2010
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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