BP: Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

Sponsor

VA Eastern Colorado Health Care System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01118208

Collaborator

United States Department of Defense (U.S. Fed)

303

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Accidental Overdose Deliberate Overdose Suicide, Attempted	Other: Blister packaging medications Other: Dispense as usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

303 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Blister Packaging

Patients will receive all prescription medications on blister pack cards.

Other: Blister packaging medications

Dispensing prescription medications on pre-filled blister package cards.

Other Names:

Blister cards, bubble packs, unit-dose packaging.

Active Comparator: Dispense as Usual

Patients will receive all prescription medications in standard pill bottles.

Other: Dispense as usual

Dispensing prescription medications in standard pill bottles.

Outcome Measures

Primary Outcome Measures

Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS) [monthly for 12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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