Medication AdherenceBPNCT01118208
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response
A study testing Blister packaging medications and Dispense as usual in people with Medication Adherence and Accidental Overdose, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Accidental Overdose, Deliberate Overdose
- What is being tested?
- Blister packaging medications and Dispense as usual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality
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.
- Being tested
- Blister packaging medications, Dispense as usual
- Keywords
- Medication adherence, Accidental overdose, Deliberate overdose, Suicide, attempted
- Medical subject headings
- Medication Adherence, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blister packaging medicationsOther
Also called Blister cards, bubble packs, unit-dose packaging.
Dispensing prescription medications on pre-filled blister package cards.
Dispense as usualOther
Dispensing prescription medications in standard pill bottles.
| Study group | Role | What they receive |
|---|---|---|
| Blister Packaging | Experimental | Patients will receive all prescription medications on blister pack cards. Receives: Other: Blister packaging medications |
| Dispense as Usual | Active comparator | Patients will receive all prescription medications in standard pill bottles. Receives: Other: Dispense as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)
Measured: monthly for 12 months
Secondary outcomes (1)
Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)
Both accidental and intentional overdoses will be assessed.
Measured: monthly for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Peter M. Gutierrez, VA Eastern Colorado Health Care System
- Investigators
- Peter M Gutierrez, Ph.D., Principal investigator, VA VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118208
- Sponsor's protocol ID
- W81XWH-09-1-0723
- Acronym
- BP
- Status last verified
- Oct 2017
- First submitted
- 4 May 2010
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutierrez PM, Wortzel HS, Forster JE, Leitner RA, Hostetter TA, Brenner LA. Blister Packaging Medication Increases Treatment Adherence in Psychiatric Patients. J Psychiatr Pract. 2017 Sep;23(5):320-327. doi: 10.1097/PRA.0000000000000252.
PubMed 28961661
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT01118208
- Acronym / sponsor ID
- BP / W81XWH-09-1-0723
- Keywords
- Medication adherence, Accidental overdose, Deliberate overdose, Suicide, attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Sep 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blister Packaging | Experimental | Other: Blister packaging medicationsPatients will receive all prescription medications on blister pack cards. |
| Dispense as Usual | Active comparator | Other: Dispense as usualPatients will receive all prescription medications in standard pill bottles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age 18 or older
- diagnosed with major affective disorder,
- bipolar affective disorder,
- post-traumatic stress disorder, or
- schizophrenia (or any combination of these diagnoses)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blister packaging medicationsAlso: Blister cards, bubble packs, unit-dose packaging.Dispensing prescription medications on pre-filled blister package cards. | Other | Blister Packaging |
| Dispense as usualDispensing prescription medications in standard pill bottles. | Other | Dispense as Usual |
Primary outcome
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)
Time frame: monthly for 12 months
1 secondary outcome
Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)
Time frame: monthly for 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Results publication: PubMed 28961661Gutierrez PM, Wortzel HS, Forster JE, Leitner RA, Hostetter TA, Brenner LA. Blister Packaging Medication Increases Treatment Adherence in Psychiatric Patients. J Psychiatr Pract. 2017 Sep;23(5):320-327. doi: 10.1097/PRA.0000000000000252.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Gutierrez, Ph.D. principal investigator
VA VISN 19 MIRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blister packaging medications and Dispense as usual in people with Medication Adherence and Accidental Overdose, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS) (time frame: monthly for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01118208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.