Blister Packaging Medication to Increase Treatment Adherence and Clinical Response (BP)
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Purpose
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 | Intervention |
|---|---|
|
Medication Adherence Accidental Overdose Deliberate Overdose Suicide, Attempted |
Other: Blister packaging medications Other: Dispense as usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality |
- Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS) [ Time Frame: monthly for 12 months ] [ Designated as safety issue: Yes ]
- Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ) [ Time Frame: monthly for 12 months ] [ Designated as safety issue: Yes ]Both accidental and intentional overdoses will be assessed.
| Estimated Enrollment: | 419 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Rebecca Leitner, B.A. | 303-399-8020 ext 2404 | rebecca.leitner@va.gov |
| Contact: Peter M Gutierrez, Ph.D. | 303-329-4408 ext 301 | peter.gutierrez@va.gov |
| United States, Colorado | |
| Denver VA Medical Center | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Principal Investigator: Peter M Gutierrez, Ph.D. | |
| Principal Investigator: | Peter M Gutierrez, Ph.D. | VA VISN 19 MIRECC |
More Information
No publications provided
| Responsible Party: | Peter M. Gutierrez, Clinical/Research Psychologist, VA Eastern Colorado Health Care System |
| ClinicalTrials.gov Identifier: | NCT01118208 History of Changes |
| Other Study ID Numbers: | W81XWH-09-1-0723 |
| Study First Received: | May 4, 2010 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Federal Government United States: U.S. Army Medical Research and Materiel Command (USAMRMC), Office of Research Protections (ORP), Human Research Protection Office (HRPO) |
Keywords provided by VA Eastern Colorado Health Care System:
|
Medication adherence Accidental overdose Deliberate overdose Suicide, attempted |
Additional relevant MeSH terms:
|
Overdose Suicide Suicide, Attempted Poisoning |
Substance-Related Disorders Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013