Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Blister packaging medications
* Other: Dispense as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blister Packaging<br>Patients will receive all prescription medications on blister pack cards. | Other: Blister packaging medications<br>* Dispensing prescription medications on pre-filled blister package cards.<br>* Other names: Blister cards, bubble packs, unit-dose packaging.;|
| Active Comparator: Dispense as Usual<br>Patients will receive all prescription medications in standard pill bottles. | Other: Dispense as usual<br>* Dispensing prescription medications in standard pill bottles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS) |  | monthly for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ) | Both accidental and intentional overdoses will be assessed. | monthly for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Accidental overdose, Deliberate overdose, Suicide, attempted