Blister Packaging Medication to Increase Treatment Adherence and Clinical Response (BP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter M. Gutierrez, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01118208
First received: May 4, 2010
Last updated: March 21, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS) [ Time Frame: monthly for 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: June 2014
Estimated Primary Completion Date: June 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118208

Locations
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
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: March 21, 2014
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 July 24, 2014