Clinical trial NCT01118208: Blister Packaging Medication to Increase Treatment Adherence and Clinical Response
Official title: Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Accidental Overdose
Deliberate Overdose
Suicide, Attempted
Keywords: Medication adherence
Accidental overdose
Deliberate overdose
Suicide, attempted
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2010-05-06
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)
timeFrame: monthly for 12 months
Secondary outcomes:
measure: Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)
timeFrame: monthly for 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
Study officials:
affiliation: VA VISN 19 MIRECC
name: Peter M Gutierrez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.