StrokeINSTINCTNCT00349479
Increasing Stroke Treatment Through Interventional Change Tactics Study
A study testing Barrier assessment / interactive educational intervention in people with Stroke, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Barrier assessment / interactive educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Mar 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician staffed emergency department at all times
- 24/7 CT scanning availability
- Computerized pharmacy dispensing system for the emergency department or thrombolytic use log
- Agreement to participate and identified site investigator
Who cannot join
- Primary children's, psychiatric, or long-term (convalescent) care hospital
- Established academic comprehensive stroke center (Detroit Receiving Hospital, Henry Ford Hospital, University of Michigan)
- Annual emergency department volume greater than 100,000 patients per year (only one hospital)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Department of Emergency Medicine
Ann Arbor, Michigan, 48106
About this study
Official title: Clinical Trial to Increase t-PA Use in Stroke Treatment
The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.
Read the detailed description
Stroke is a major public health problem. Only 1 to 3 percent of people with stroke patients in community settings are receiving tissue plasminogen activator (t-PA) therapy ten years after it was approved by the Food and Drug Administration (FDA). Data from academic stroke teams, stroke patient arrival times, and thrombolytic therapy (clot-dissolving) in myocardial infarction suggest substantially higher treatment rates are possible. The development and implementation of educational interventions to motivate physicians, other healthcare providers, and healthcare organizations, to learn the principles of acute stroke care is a high-priority.
Limited prior work found a combination of community and professional education increased thrombolytic therapy for stroke from a pre-intervention rate of 2.2 percent to a post-intervention rate of 11.3 percent, with the data suggesting the professional education was the critical element for increasing use.
The Increasing Stroke Treatment through Interventional behavioral Change Tactics (INSTINCT) trial is designed to evaluate a standardized, system-based barrier assessment and interactive educational intervention (BA-IEI) for increasing appropriate t-PA use in people with stroke. This multi-center, randomized, controlled study will be conducted at 24 hospital sites nationwide.
The intervention, BA-IEI, targets emergency departments and is based on adult education and behavior change theory. BA-IEI is designed for replication in community health initiatives. It incorporates local stroke champion development, hospital-specific barrier evaluation, mixed CME targeting identified barriers, performance feedback, protocol development, and academic detailing. The primary endpoint will be the increase in appropriate use of t-PA for stroke with evaluations of change in emergency physician knowledge on t-PA use.
The primary aims of this study are to determine if a BA-IEI is effective in increasing appropriate t-PA use in stroke, and if BA-IEI improves emergency physician knowledge, beliefs, and attitudes regarding the use of t-PA for acute stroke.
Results from this study may lead to an effective method for increasing the use of t-PA for stroke.
- Conditions
- Stroke
- Being tested
- Barrier assessment / interactive educational intervention
- Keywords
- stroke, tissue plasminogen activator, t-PA, barrier assessment and interactive educational intervention, BA-IEI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrier assessment / interactive educational interventionBehavioural
Intervention hospitals received a barrier assessment - interactive educational intervention (BA-IEI) which included: on-site barrier assessment, annual "stroke champions" meetings, stroke center telephone access, quarterly mock stroke codes, and ongoing feedback and education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Barrier assessment / interactive educational intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in t-PA use with assessment of appropriateness of use and complications.
The primary outcome was based on the change in the rate of tPA use between the "pre-intervention" period (Jan 2005 to Dec 2006) and the "post-intervention" period immediately following the conclusion of the first mock "code stroke / CME intervention (Jan 2008 to Jan 2010).
Measured: January 2005 to January 2010
Secondary outcomes (4)
Changes in emergency physician knowledge and attitudes regarding thrombolytic use.
Measured: 2007 to 2009
Intracerebral Hemorrhage
Measured: 2007 to 2010
Systemic hemorrhage
Measured: 2007 to 2010
tPA-use guideline deviations
Measured: 2007 to 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startMay 2005
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Phillip A. Scott, University of Michigan
- Investigators
- Phillip A. Scott, MD, Principal investigator, University of MichiganMary Haan, MPH, DrPhD, Principal investigator, University of Michigan, Co-InvestigatorJohn M. Kalbfleisch, Math, PhD, Principal investigator, University of Michigan, Co-InvestigatorLewis Morgenstern, MD, Principal investigator, University of Michigan, Co-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349479
- Sponsor's protocol ID
- R01NS050372-02
- Acronym
- INSTINCT
- Status last verified
- Feb 2013
- First submitted
- 5 Jul 2006
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scott PA, Frederiksen SM, Kalbfleisch JD, Xu Z, Meurer WJ, Caveney AF, Sandretto A, Holden AB, Haan MN, Hoeffner EG, Ansari SA, Lambert DP, Jaggi M, Barsan WG, Silbergleit R. Safety of intravenous thrombolytic use in four emergency departments without acute stroke teams. Acad Emerg Med. 2010 Oct;17(10):1062-71. doi: 10.1111/j.1553-2712.2010.00868.x.
PubMed 21040107Meurer WJ, Majersik JJ, Frederiksen SM, Kade AM, Sandretto AM, Scott PA. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med. 2011 May 6;11:5. doi: 10.1186/1471-227X-11-5.
PubMed 21548943Meurer WJ, Caveney AF, Lo A, Zhang L, Frederiksen SM, Sandretto AM, Silbergleit R, Scott PA. Lack of association between pretreatment neurology consultation and subsequent protocol deviation in tissue plasminogen activator-treated patients with stroke. Stroke. 2010 Sep;41(9):2098-101. doi: 10.1161/STROKEAHA.110.588491. Epub 2010 Aug 5.
PubMed 20689081Caveney AF, Silbergleit R, Frederiksen S, Meurer WJ, Hickenbottom SL, Smith RW, Scott PA. Resource utilization and outcome at a university versus a community teaching hospital in tPA treated stroke patients: a retrospective cohort study. BMC Health Serv Res. 2010 Feb 19;10:44. doi: 10.1186/1472-6963-10-44.
PubMed 20170487Meurer WJ, Scott PA, Caveney AF, Majersik JJ, Frederiksen SM, Sandretto A, Holden AB, Silbergleit R. Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator. Int J Stroke. 2010 Jun;5(3):163-6. doi: 10.1111/j.1747-4949.2010.00425.x.
PubMed 20536612Scott PA. Enhancing community delivery of tissue plasminogen activator in stroke through community-academic collaborative clinical knowledge translation. Emerg Med Clin North Am. 2009 Feb;27(1):115-36, ix. doi: 10.1016/j.emc.2008.07.001.
PubMed 19218023Meurer WJ, Frederiksen SM, Majersik JJ, Zhang L, Sandretto A, Scott PA. Qualitative data collection and analysis methods: the INSTINCT trial. Acad Emerg Med. 2007 Nov;14(11):1064-71. doi: 10.1197/j.aem.2007.05.005. Epub 2007 Jul 24.
PubMed 17652268Scott PA, Xu Z, Meurer WJ, Frederiksen SM, Haan MN, Westfall MW, Kothari SU, Morgenstern LB, Kalbfleisch JD. Attitudes and beliefs of Michigan emergency physicians toward tissue plasminogen activator use in stroke: baseline survey results from the INcreasing Stroke Treatment through INteractive behavioral Change Tactic (INSTINCT) trial hospitals. Stroke. 2010 Sep;41(9):2026-32. doi: 10.1161/STROKEAHA.110.581942. Epub 2010 Aug 12.
PubMed 20705931Skolarus LE, Scott PA, Burke JF, Adelman EE, Frederiksen SM, Kade AM, Kalbfleisch JD, Ford AL, Meurer WJ. Antihypertensive treatment prolongs tissue plasminogen activator door-to-treatment time: secondary analysis of the INSTINCT trial. Stroke. 2012 Dec;43(12):3392-4. doi: 10.1161/STROKEAHA.112.662684. Epub 2012 Oct 2.
PubMed 23033348Scott PA, Meurer WJ, Frederiksen SM, Kalbfleisch JD, Xu Z, Haan MN, Silbergleit R, Morgenstern LB; INSTINCT Investigators. A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial. Lancet Neurol. 2013 Feb;12(2):139-48. doi: 10.1016/S1474-4422(12)70311-3. Epub 2012 Dec 21.
PubMed 23260188
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Increase t-PA Use in Stroke Treatment
- ClinicalTrials.gov ID
- NCT00349479
- Acronym / sponsor ID
- INSTINCT / R01NS050372-02
- Conditions
- Stroke
- Keywords
- stroke, tissue plasminogen activator, t-PA, barrier assessment and interactive educational intervention, BA-IEI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Jul 2006 (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.
The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.
Detailed description
Stroke is a major public health problem. Only 1 to 3 percent of people with stroke patients in community settings are receiving tissue plasminogen activator (t-PA) therapy ten years after it was approved by the Food and Drug Administration (FDA). Data from academic stroke teams, stroke patient arrival times, and thrombolytic therapy (clot-dissolving) in myocardial infarction suggest substantially higher treatment rates are possible. The development and implementation of educational interventions to motivate physicians, other healthcare providers, and healthcare organizations, to learn the principles of acute stroke care is a high-priority.
Limited prior work found a combination of community and professional education increased thrombolytic therapy for stroke from a pre-intervention rate of 2.2 percent to a post-intervention rate of 11.3 percent, with the data suggesting the professional education was the critical element for increasing use.
The Increasing Stroke Treatment through Interventional behavioral Change Tactics (INSTINCT) trial is designed to evaluate a standardized, system-based barrier assessment and interactive educational intervention (BA-IEI) for increasing appropriate t-PA use in people with stroke. This multi-center, randomized, controlled study will be conducted at 24 hospital sites nationwide.
The intervention, BA-IEI, targets emergency departments and is based on adult education and behavior change theory. BA-IEI is designed for replication in community health initiatives. It incorporates local stroke champion development, hospital-specific barrier evaluation, mixed CME targeting identified barriers, performance feedback, protocol development, and academic detailing. The primary endpoint will be the increase in appropriate use of t-PA for stroke with evaluations of change in emergency physician knowledge on t-PA use.
The primary aims of this study are to determine if a BA-IEI is effective in increasing appropriate t-PA use in stroke, and if BA-IEI improves emergency physician knowledge, beliefs, and attitudes regarding the use of t-PA for acute stroke.
Results from this study may lead to an effective method for increasing the use of t-PA for stroke.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Barrier assessment / interactive educational intervention |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Physician staffed emergency department at all times
- 24/7 CT scanning availability
- Computerized pharmacy dispensing system for the emergency department or thrombolytic use log
- Agreement to participate and identified site investigator
Key exclusion criteria (3 listed)
- Primary children's, psychiatric, or long-term (convalescent) care hospital
- Established academic comprehensive stroke center (Detroit Receiving Hospital, Henry Ford Hospital, University of Michigan)
- Annual emergency department volume greater than 100,000 patients per year (only one hospital)
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 |
|---|---|---|
| Barrier assessment / interactive educational interventionIntervention hospitals received a barrier assessment - interactive educational intervention (BA-IEI) which included: on-site barrier assessment, annual "stroke champions" meetings, stroke center telephone access, quarterly mock stroke codes, and ongoing feedback and education. | Behavioural | Intervention |
Primary outcome
Change in t-PA use with assessment of appropriateness of use and complications.
Time frame: January 2005 to January 2010
The primary outcome was based on the change in the rate of tPA use between the "pre-intervention" period (Jan 2005 to Dec 2006) and the "post-intervention" period immediately following the conclusion of the first mock "code stroke / CME intervention (Jan 2008 to Jan 2010).
4 secondary outcomes
Changes in emergency physician knowledge and attitudes regarding thrombolytic use.
Time frame: 2007 to 2009
Intracerebral Hemorrhage
Time frame: 2007 to 2010
Systemic hemorrhage
Time frame: 2007 to 2010
tPA-use guideline deviations
Time frame: 2007 to 2010
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 25 Feb 2013.
- Background: PubMed 21040107Scott PA, Frederiksen SM, Kalbfleisch JD, Xu Z, Meurer WJ, Caveney AF, Sandretto A, Holden AB, Haan MN, Hoeffner EG, Ansari SA, Lambert DP, Jaggi M, Barsan WG, Silbergleit R. Safety of intravenous thrombolytic use in four emergency departments without acute stroke teams. Acad Emerg Med. 2010 Oct;17(10):1062-71. doi: 10.1111/j.1553-2712.2010.00868.x.
- Background: PubMed 21548943Meurer WJ, Majersik JJ, Frederiksen SM, Kade AM, Sandretto AM, Scott PA. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med. 2011 May 6;11:5. doi: 10.1186/1471-227X-11-5.
- Background: PubMed 20689081Meurer WJ, Caveney AF, Lo A, Zhang L, Frederiksen SM, Sandretto AM, Silbergleit R, Scott PA. Lack of association between pretreatment neurology consultation and subsequent protocol deviation in tissue plasminogen activator-treated patients with stroke. Stroke. 2010 Sep;41(9):2098-101. doi: 10.1161/STROKEAHA.110.588491. Epub 2010 Aug 5.
- Background: PubMed 20170487Caveney AF, Silbergleit R, Frederiksen S, Meurer WJ, Hickenbottom SL, Smith RW, Scott PA. Resource utilization and outcome at a university versus a community teaching hospital in tPA treated stroke patients: a retrospective cohort study. BMC Health Serv Res. 2010 Feb 19;10:44. doi: 10.1186/1472-6963-10-44.
- Background: PubMed 20536612Meurer WJ, Scott PA, Caveney AF, Majersik JJ, Frederiksen SM, Sandretto A, Holden AB, Silbergleit R. Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator. Int J Stroke. 2010 Jun;5(3):163-6. doi: 10.1111/j.1747-4949.2010.00425.x.
- Background: PubMed 19218023Scott PA. Enhancing community delivery of tissue plasminogen activator in stroke through community-academic collaborative clinical knowledge translation. Emerg Med Clin North Am. 2009 Feb;27(1):115-36, ix. doi: 10.1016/j.emc.2008.07.001.
- Background: PubMed 17652268Meurer WJ, Frederiksen SM, Majersik JJ, Zhang L, Sandretto A, Scott PA. Qualitative data collection and analysis methods: the INSTINCT trial. Acad Emerg Med. 2007 Nov;14(11):1064-71. doi: 10.1197/j.aem.2007.05.005. Epub 2007 Jul 24.
- Results publication: PubMed 20705931Scott PA, Xu Z, Meurer WJ, Frederiksen SM, Haan MN, Westfall MW, Kothari SU, Morgenstern LB, Kalbfleisch JD. Attitudes and beliefs of Michigan emergency physicians toward tissue plasminogen activator use in stroke: baseline survey results from the INcreasing Stroke Treatment through INteractive behavioral Change Tactic (INSTINCT) trial hospitals. Stroke. 2010 Sep;41(9):2026-32. doi: 10.1161/STROKEAHA.110.581942. Epub 2010 Aug 12.
- Results publication: PubMed 23033348Skolarus LE, Scott PA, Burke JF, Adelman EE, Frederiksen SM, Kade AM, Kalbfleisch JD, Ford AL, Meurer WJ. Antihypertensive treatment prolongs tissue plasminogen activator door-to-treatment time: secondary analysis of the INSTINCT trial. Stroke. 2012 Dec;43(12):3392-4. doi: 10.1161/STROKEAHA.112.662684. Epub 2012 Oct 2.
- Derived from this study: PubMed 23260188Scott PA, Meurer WJ, Frederiksen SM, Kalbfleisch JD, Xu Z, Haan MN, Silbergleit R, Morgenstern LB; INSTINCT Investigators. A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial. Lancet Neurol. 2013 Feb;12(2):139-48. doi: 10.1016/S1474-4422(12)70311-3. Epub 2012 Dec 21.
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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.
Phillip A. Scott, MD principal investigator
University of Michigan
Mary Haan, MPH, DrPhD principal investigator
University of Michigan, Co-Investigator
John M. Kalbfleisch, Math, PhD principal investigator
University of Michigan, Co-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrier assessment / interactive educational intervention in people with Stroke, run by University of Michigan 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 4 inclusion and 3 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 25 Feb 2013. 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?
Change in t-PA use with assessment of appropriateness of use and complications. (time frame: January 2005 to January 2010). 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 NCT00349479, which also lists 10 linked publications.
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 25 Feb 2013.