Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

Not Applicable

Completed

• Conditions: Medication Adherence; Deliberate Overdose; Suicide, Attempted; Accidental Overdose
• Interventions: Other: Blister packaging medications; Other: Dispense as usual

• Registration Number: NCT01118208
• Lead Sponsor: VA Eastern Colorado Health Care System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-06
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blister Packaging	Blister packaging medications	Patients will receive all prescription medications on blister pack cards.
Dispense as Usual	Dispense as usual	Patients will receive all prescription medications in standard pill bottles.

Primary Outcome Measures

Name	Time	Method
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)	monthly for 12 months

Secondary Outcome Measures

Name	Time	Method
Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)	monthly for 12 months	Both accidental and intentional overdoses will be assessed.

Trial Locations

Locations (1)

Denver VA Medical Center; 🇺🇸 Denver, Colorado, United States