Transient Ischemic AttackPREVENTNCT02769338
Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms
A study testing Quality Improvement Program in people with Transient Ischemic Attack and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This program will seek to implement a quality improvement program to improve the care of Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The investigators will evaluate the implementation and effectiveness of the quality improvement program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transient Ischemic Attack, Stroke
- What is being tested?
- Quality Improvement Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,292 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- This program will seek VA hospitals that are self-designated as either a VHA Primary Stroke Center or a Limited Hours Stroke Facility or Supporting Stroke Center.
- Eligibility for staff interviews is based on involvement in the QI intervention and willingness to participate.
Who cannot join
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)
This program will seek to implement a quality improvement program to improve the care of Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The investigators will evaluate the implementation and effectiveness of the quality improvement program.
Read the detailed description
Aim 1. To develop a quality improvement program to improve the care of Veterans with TIA or minor stroke that can be deployed nationwide. The program will include multiple components: a reporting system that is based on validated electronic quality measures (eCQMs) that will allow staff to monitor the time-sensitive processes of care and outcomes of their population of Veterans with TIA or minor stroke; clinical protocols to improve the timeliness and completeness of care; professional education materials; and clinical note templates for use by nursing and pharmacy staff. Lessons learned at the individual sites engaged in the quality improvement program will be shared across sites by use of a web-based platform and a virtual collaborative. We will assess end user's assessment of the program and its core elements.
Aim 2. To evaluate the effectiveness of the Aim 1 QI intervention program for Veterans with TIA or minor stroke against usual care. Teams at the 6 intervention sites will be given the quality improvement program components. The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate.
Aim 3. To evaluate the implementation of the QI intervention program across the 6 participating sites. The two primary implementation outcomes will be the number of implementation activities completed during the one-year active implementation period and the final level of team organization (defined as the Group Organization (GO Score)) for improving TIA care at the end of the 12-month active implementation period.
Secondary Aim To evaluate the sustainability of the program. Sustainability will be evaluated over a one-year period that begins immediately after the one-year active implementation period. We will compare the Without-Fail rate in the sustainability period to the baseline period and the post-implementation period.
- Conditions
- Transient Ischemic Attack, Stroke
- Being tested
- Quality Improvement Program
- Keywords
- Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement ProgramOther
Also called QI Intervention
The Intervention is a QI Program that will include multiple components as described above.
| Study group | Role | What they receive |
|---|---|---|
| QI with External Facilitation | Experimental | Receive external facilitation to support implementation of the quality improvement program Receives: Other: Quality Improvement Program |
| Control | No intervention | Non-Intervention VA Medical Centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Without-fail Care Rate
Teams at the 6 intervention sites will be given both the QI program (to improve care) and eCQM data (to monitor the care they are delivering to their patients). The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate. Determined by analysis of electronic medical record data.
Measured: Over the course of One Year active implementation
Secondary outcomes (4)
Recurrent Vascular Events
The recurrent event endpoint included: congestive heart failure, myocardial infarction/acute coronary syndrome, ischemic stroke, TIA, ventricular arrhythmia, or death from any cause
Measured: 90-days from presentation
The Group Organization (GO) Score
The GO Score refers to the Group Organization Score for improving TIA care quality; it is a measure of team activation and cohesion. The GO score is measured on a scale of 0-10 based on specific practices in place during a given time period and scored by the evaluation team. A score of 0-3 indicates the absence of a facility-wide approach; 4-5 reflects a developing facility-wide approach; 6-7 denotes basic proficiency with the presence of a comprehensive facility-wide program; and 8-10 indicates the presence of a mature, facility-wide system that can sustain key personnel turnover. The GO Score was measured only among the N=6 PREVENT sites.
Measured: Measured at the end of the one-year active implementation period
Number of Quality Improvement Activities Completed
The number of implementation activities completed during the one-year active implementation period
Measured: One-year active implementation period
Program Satisfaction
Overall staff satisfaction with the program was assessed with a single question with the response scale ranging from 1 to 7 where 7 indicated "extremely satisfied." Program satisfaction was measured only at the six PREVENT intervention sites.
Measured: Measured at the end of the one-year active implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 2,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawn M. Bravata, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, INTeresa M. Damush, PhD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769338
- Sponsor's protocol ID
- QUX 16-006
- Acronym
- PREVENT
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2016
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.
Publications
Penney LS, Homoya BJ, Damush TM, Rattray NA, Miech EJ, Myers LJ, Baird S, Cheatham A, Bravata DM. Seeding Structures for a Community of Practice Focused on Transient Ischemic Attack (TIA): Implementing Across Disciplines and Waves. J Gen Intern Med. 2021 Feb;36(2):313-321. doi: 10.1007/s11606-020-06135-z. Epub 2020 Sep 1.
PubMed 32875499Rattray NA, Damush TM, Miech EJ, Homoya B, Myers LJ, Penney LS, Ferguson J, Giacherio B, Kumar M, Bravata DM. Empowering Implementation Teams with a Learning Health System Approach: Leveraging Data to Improve Quality of Care for Transient Ischemic Attack. J Gen Intern Med. 2020 Nov;35(Suppl 2):823-831. doi: 10.1007/s11606-020-06160-y. Epub 2020 Sep 1.
PubMed 32875510Li J, Zhang Y, Myers LJ, Bravata DM. Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect. J Biopharm Stat. 2019;29(4):663-674. doi: 10.1080/10543406.2019.1633658. Epub 2019 Jul 18.
PubMed 31317805Bravata DM, Myers LJ, Homoya B, Miech EJ, Rattray NA, Perkins AJ, Zhang Y, Ferguson J, Myers J, Cheatham AJ, Murphy L, Giacherio B, Kumar M, Cheng E, Levine DA, Sico JJ, Ward MJ, Damush TM. The protocol-guided rapid evaluation of veterans experiencing new transient neurological symptoms (PREVENT) quality improvement program: rationale and methods. BMC Neurol. 2019 Nov 20;19(1):294. doi: 10.1186/s12883-019-1517-x.
PubMed 31747879Bravata DM, Myers LJ, Perkins AJ, Zhang Y, Miech EJ, Rattray NA, Penney LS, Levine D, Sico JJ, Cheng EM, Damush TM. Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2015920. doi: 10.1001/jamanetworkopen.2020.15920.
PubMed 32897372Damush TM, Miech EJ, Rattray NA, Homoya B, Penney LS, Cheatham A, Baird S, Myers J, Austin C, Myers LJ, Perkins AJ, Zhang Y, Giacherio B, Kumar M, Murphy LD, Sico JJ, Bravata DM. Implementation Evaluation of a Complex Intervention to Improve Timeliness of Care for Veterans with Transient Ischemic Attack. J Gen Intern Med. 2021 Feb;36(2):322-332. doi: 10.1007/s11606-020-06100-w. Epub 2020 Nov 3.
PubMed 33145694Damush TM, Penney LS, Miech EJ, Rattray NA, Baird SA, Cheatham AJ, Austin C, Sexson A, Myers LJ, Bravata DM. Acceptability of a complex team-based quality improvement intervention for transient ischemic attack: a mixed-methods study. BMC Health Serv Res. 2021 May 12;21(1):453. doi: 10.1186/s12913-021-06318-2.
PubMed 33980224Baird SA, Damush TM, Rattray NA, Penney LS, Miech EJ, Homoya BJ, Ferguson J, Myers LJ, Bravata DM. Using a "Kickoff" to build implementation partner teams and action plans for active implementation of a quality improvement project. Front Health Serv. 2025 Jun 10;5:1580653. doi: 10.3389/frhs.2025.1580653. eCollection 2025.
PubMed 40556841Myers LJ, Perkins AJ, Zhang Y, Bravata DM. Identifying transient ischemic attack (TIA) patients at high-risk of adverse outcomes: development and validation of an approach using electronic health record data. BMC Neurol. 2022 Jul 12;22(1):256. doi: 10.1186/s12883-022-02776-1.
PubMed 35820867Bravata DM, Miech EJ, Myers LJ, Perkins AJ, Zhang Y, Rattray NA, Baird SA, Penney LS, Austin C, Damush TM. The Perils of a "My Work Here is Done" perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack. BMC Health Serv Res. 2022 Jul 4;22(1):857. doi: 10.1186/s12913-022-08207-8.
PubMed 35787273Penney LS, Damush TM, Rattray NA, Miech EJ, Baird SA, Homoya BJ, Myers LJ, Bravata DM. Multi-tiered external facilitation: the role of feedback loops and tailored interventions in supporting change in a stepped-wedge implementation trial. Implement Sci Commun. 2021 Jul 27;2(1):82. doi: 10.1186/s43058-021-00180-3.
PubMed 34315540
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)
- ClinicalTrials.gov ID
- NCT02769338
- Acronym / sponsor ID
- PREVENT / QUX 16-006
- Conditions
- Transient Ischemic Attack, Stroke
- Keywords
- Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,292 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This program will seek to implement a quality improvement program to improve the care of Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The investigators will evaluate the implementation and effectiveness of the quality improvement program.
Detailed description
Aim 1. To develop a quality improvement program to improve the care of Veterans with TIA or minor stroke that can be deployed nationwide. The program will include multiple components: a reporting system that is based on validated electronic quality measures (eCQMs) that will allow staff to monitor the time-sensitive processes of care and outcomes of their population of Veterans with TIA or minor stroke; clinical protocols to improve the timeliness and completeness of care; professional education materials; and clinical note templates for use by nursing and pharmacy staff. Lessons learned at the individual sites engaged in the quality improvement program will be shared across sites by use of a web-based platform and a virtual collaborative. We will assess end user's assessment of the program and its core elements.
Aim 2. To evaluate the effectiveness of the Aim 1 QI intervention program for Veterans with TIA or minor stroke against usual care. Teams at the 6 intervention sites will be given the quality improvement program components. The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate.
Aim 3. To evaluate the implementation of the QI intervention program across the 6 participating sites. The two primary implementation outcomes will be the number of implementation activities completed during the one-year active implementation period and the final level of team organization (defined as the Group Organization (GO Score)) for improving TIA care at the end of the 12-month active implementation period.
Secondary Aim To evaluate the sustainability of the program. Sustainability will be evaluated over a one-year period that begins immediately after the one-year active implementation period. We will compare the Without-Fail rate in the sustainability period to the baseline period and the post-implementation period.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| QI with External Facilitation | Experimental | Other: Quality Improvement ProgramReceive external facilitation to support implementation of the quality improvement program |
| Control | No intervention | –Non-Intervention VA Medical Centers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- This program will seek VA hospitals that are self-designated as either a VHA Primary Stroke Center or a Limited Hours Stroke Facility or Supporting Stroke Center.
- Eligibility for staff interviews is based on involvement in the QI intervention and willingness to participate.
Key exclusion criteria (1 listed)
- Unwilling to participate
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 |
|---|---|---|
| Quality Improvement ProgramAlso: QI InterventionThe Intervention is a QI Program that will include multiple components as described above. | Other | QI with External Facilitation |
Primary outcome
Effectiveness: Without-fail Care Rate
Time frame: Over the course of One Year active implementation
Teams at the 6 intervention sites will be given both the QI program (to improve care) and eCQM data (to monitor the care they are delivering to their patients). The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate. Determined by analysis of electronic medical record data.
4 secondary outcomes
Recurrent Vascular Events
Time frame: 90-days from presentation
The Group Organization (GO) Score
Time frame: Measured at the end of the one-year active implementation period
Number of Quality Improvement Activities Completed
Time frame: One-year active implementation period
Program Satisfaction
Time frame: Measured at the end of the one-year active implementation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32875499Penney LS, Homoya BJ, Damush TM, Rattray NA, Miech EJ, Myers LJ, Baird S, Cheatham A, Bravata DM. Seeding Structures for a Community of Practice Focused on Transient Ischemic Attack (TIA): Implementing Across Disciplines and Waves. J Gen Intern Med. 2021 Feb;36(2):313-321. doi: 10.1007/s11606-020-06135-z. Epub 2020 Sep 1.
- Background: PubMed 32875510Rattray NA, Damush TM, Miech EJ, Homoya B, Myers LJ, Penney LS, Ferguson J, Giacherio B, Kumar M, Bravata DM. Empowering Implementation Teams with a Learning Health System Approach: Leveraging Data to Improve Quality of Care for Transient Ischemic Attack. J Gen Intern Med. 2020 Nov;35(Suppl 2):823-831. doi: 10.1007/s11606-020-06160-y. Epub 2020 Sep 1.
- Background: PubMed 31317805Li J, Zhang Y, Myers LJ, Bravata DM. Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect. J Biopharm Stat. 2019;29(4):663-674. doi: 10.1080/10543406.2019.1633658. Epub 2019 Jul 18.
- Background: PubMed 31747879Bravata DM, Myers LJ, Homoya B, Miech EJ, Rattray NA, Perkins AJ, Zhang Y, Ferguson J, Myers J, Cheatham AJ, Murphy L, Giacherio B, Kumar M, Cheng E, Levine DA, Sico JJ, Ward MJ, Damush TM. The protocol-guided rapid evaluation of veterans experiencing new transient neurological symptoms (PREVENT) quality improvement program: rationale and methods. BMC Neurol. 2019 Nov 20;19(1):294. doi: 10.1186/s12883-019-1517-x.
- Results publication: PubMed 32897372Bravata DM, Myers LJ, Perkins AJ, Zhang Y, Miech EJ, Rattray NA, Penney LS, Levine D, Sico JJ, Cheng EM, Damush TM. Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2015920. doi: 10.1001/jamanetworkopen.2020.15920.
- Results publication: PubMed 33145694Damush TM, Miech EJ, Rattray NA, Homoya B, Penney LS, Cheatham A, Baird S, Myers J, Austin C, Myers LJ, Perkins AJ, Zhang Y, Giacherio B, Kumar M, Murphy LD, Sico JJ, Bravata DM. Implementation Evaluation of a Complex Intervention to Improve Timeliness of Care for Veterans with Transient Ischemic Attack. J Gen Intern Med. 2021 Feb;36(2):322-332. doi: 10.1007/s11606-020-06100-w. Epub 2020 Nov 3.
- Results publication: PubMed 33980224Damush TM, Penney LS, Miech EJ, Rattray NA, Baird SA, Cheatham AJ, Austin C, Sexson A, Myers LJ, Bravata DM. Acceptability of a complex team-based quality improvement intervention for transient ischemic attack: a mixed-methods study. BMC Health Serv Res. 2021 May 12;21(1):453. doi: 10.1186/s12913-021-06318-2.
- Derived from this study: PubMed 40556841Baird SA, Damush TM, Rattray NA, Penney LS, Miech EJ, Homoya BJ, Ferguson J, Myers LJ, Bravata DM. Using a "Kickoff" to build implementation partner teams and action plans for active implementation of a quality improvement project. Front Health Serv. 2025 Jun 10;5:1580653. doi: 10.3389/frhs.2025.1580653. eCollection 2025.
- Derived from this study: PubMed 35820867Myers LJ, Perkins AJ, Zhang Y, Bravata DM. Identifying transient ischemic attack (TIA) patients at high-risk of adverse outcomes: development and validation of an approach using electronic health record data. BMC Neurol. 2022 Jul 12;22(1):256. doi: 10.1186/s12883-022-02776-1.
- Derived from this study: PubMed 35787273Bravata DM, Miech EJ, Myers LJ, Perkins AJ, Zhang Y, Rattray NA, Baird SA, Penney LS, Austin C, Damush TM. The Perils of a "My Work Here is Done" perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack. BMC Health Serv Res. 2022 Jul 4;22(1):857. doi: 10.1186/s12913-022-08207-8.
- Derived from this study: PubMed 34315540Penney LS, Damush TM, Rattray NA, Miech EJ, Baird SA, Homoya BJ, Myers LJ, Bravata DM. Multi-tiered external facilitation: the role of feedback loops and tailored interventions in supporting change in a stepped-wedge implementation trial. Implement Sci Commun. 2021 Jul 27;2(1):82. doi: 10.1186/s43058-021-00180-3.
- Individual participant dataSharing planned: No. Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.
Related trials for Transient Ischemic Attack
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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.
Dawn M. Bravata, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Teresa M. Damush, PhD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Program in people with Transient Ischemic Attack and Stroke, run by VA Office of Research and Development 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 2 inclusion and 1 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 13 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness: Without-fail Care Rate (time frame: Over the course of One Year active implementation). 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 NCT02769338, which also lists 11 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 13 Dec 2023.