Program EvaluationESCALATESNCT02560428
Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES)
An observational study of Program Evaluation, run by Oregon Health and Science University.
Trial summary
The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Program Evaluation
- What is being tested?
- ESCALATES
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2022
- Phase
- Observational
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include all R18 grantees
Who may be able to join
- All R18 grant awardees are included in the study.
Who cannot join
- N/A
About this study
The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.
Read the detailed description
The purpose of this study is to evaluate approximately eight different R18 grants that will test practice change interventions to improve cardiovascular disease (CVD) prevention screening. The investigators will collect and analyze quantitative data (context, process, and outcomes) to identify the most effective combinations of intervention strategies for various practice types in relation to practice structure, context, and organizational characteristics associated with change in outcomes. The investigators will collect qualitative data (observation, interviews, online diaries) from grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather documents and de-identified quantitative data from grantees.
Evidence clearly shows that many people do not receive guideline-concordant health care; this is true even for low cost treatments such as Aspirin prescribing, Blood pressure and Cholesterol control and Smoking cessation (the ABCS) known to prevent cardiovascular disease (CVD). In hospitals and integrated care systems with substantial resources, large quality improvement campaigns have been shown to increase adherence to guidelines by creating communities of learning that change behavior on a large scale. Agency for Healthcare Research and Quality (AHRQ) and the Patient Centered Outcomes Research Institute (PCORI) are partnering to launch a campaign to promote the improvement of guideline-based CVD preventive care in small primary care practices with limited resources and experience with quality improvement ("Implementation" RFA-HS-14-008). The practices for each of these R18 grants will be in a contiguous geographic region. This study will evaluate each of these R18 implementation grants.
The investigators' strategy is to conduct a prospective observational analysis to evaluate the effectiveness of the R18s ABCS quality improvement initiatives. To do this, the investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators will also gather de-identified quantitative data that the R18s collected.
- Conditions
- Program Evaluation
- Being tested
- ESCALATES
- Keywords
- Mixed Methods, Cardiovascular Health, Implementation Evaluation, Cardiovascular Prevention Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESCALATESBehavioural
Also called EvidenceNOW
The investigators collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators also gather de-identified quantitative data that the R18s collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period.
Acute myocardial infarction (AMI), ischemic vascular disease (IVD), percutaneous coronary interventions (PCI)
Measured: Quarterly for 4 years
Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period.
Patients 18years and older and 85years or younger with at least one face to face visit and active diagnosis of essential hypertension at any time before the first date of month 7 of the measurement period and who did not (i) have an active diagnosis of pregnancy at any time during the measurement period; or (ii) have evidence of end stage renal disease, dialysis, or renal transplant before or during the measurement period
Measured: Quarterly for 4 years
Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period.
Patients 21 and older with at least one face to face visit who have an active diagnosis of clinical atherosclerotic cardiovascular, LDL-C result >= 190mg/dL, aged 40 to 75years at the beginning of the measurement period with an active diagnosis of diabetes with the highest LDL-C result of 70 to 189mg/ dL and who (i) did not have adverse effect, allergy or intolerance to statin medication therapy; (ii) did not have an active diagnosis of pregnancy or breastfeeding; (iii) did not receive palliative care; (iv) did not have an active liver disease or hepatic disease of insufficiency; (v) did not have end stage renal disease; or (vi) did not have a most recent LDL-C results<70mg/dL for patients with a diabetes diagnosis who are not currently receiving statin medication therapy during the current measurement period or any time period.
Measured: Quarterly for 4 years
Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user.
Patients 18years and older as of the first day of the measurement period with at least two visits during the measurement period
Measured: Quarterly for 4 years
Secondary outcomes (2)
Practice capacity for change measured by adaptive reserve (AR)
Measured: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum)
Practice capacity for quality improvement measured by CPCQ
Measured: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Program EvaluationStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Rutgers University, HealthPartners Institute, University of Michigan, Case Western Reserve University
- Responsible party
- Principal investigator, Deborah Cohen, Oregon Health and Science University
- Investigators
- Debbie Cohen, PhD, Principal investigator, OHSU, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560428
- Sponsor's protocol ID
- 11482
- Acronym
- ESCALATES
- Status last verified
- May 2024
- First submitted
- 21 Sep 2015
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen DJ, Balasubramanian BA, Gordon L, Marino M, Ono S, Solberg LI, Crabtree BF, Stange KC, Davis M, Miller WL, Damschroder LJ, McConnell KJ, Creswell J. A national evaluation of a dissemination and implementation initiative to enhance primary care practice capacity and improve cardiovascular disease care: the ESCALATES study protocol. Implement Sci. 2016 Jun 29;11(1):86. doi: 10.1186/s13012-016-0449-8.
PubMed 27358078Weiner BJ, Pignone MP, DuBard CA, Lefebvre A, Suttie JL, Freburger JK, Cykert S. Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol. Implement Sci. 2015 Nov 14;10:160. doi: 10.1186/s13012-015-0348-4.
PubMed 26577091Shelley DR, Ogedegbe G, Anane S, Wu WY, Goldfeld K, Gold HT, Kaplan S, Berry C. Testing the use of practice facilitation in a cluster randomized stepped-wedge design trial to improve adherence to cardiovascular disease prevention guidelines: HealthyHearts NYC. Implement Sci. 2016 Jul 4;11(1):88. doi: 10.1186/s13012-016-0450-2.
PubMed 27377404Kaufman A, Rhyne RL, Anastasoff J, Ronquillo F, Nixon M, Mishra S, Poola C, Page-Reeves J, Nkouaga C, Cordova C, Larson RS. Health Extension and Clinical and Translational Science: An Innovative Strategy for Community Engagement. J Am Board Fam Med. 2017 Jan 2;30(1):94-99. doi: 10.3122/jabfm.2017.01.160119.
PubMed 28062823Reck J. Primary care provider burnout: implications for states & strategies for mitigation. National Academy for State Health Policy. 2017 Jan.
Solberg LI. What do we know and need to know about transforming primary care? Fam Pract. 2017 Aug 1;34(4):371-372. doi: 10.1093/fampra/cmx031. No abstract available.
PubMed 28475721Parchman ML, Fagnan LJ, Dorr DA, Evans P, Cook AJ, Penfold RB, Hsu C, Cheadle A, Baldwin LM, Tuzzio L. Study protocol for "Healthy Hearts Northwest": a 2 x 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. doi: 10.1186/s13012-016-0502-7.
PubMed 27737719Solberg LI, Kuzel A, Parchman ML, Shelley DR, Dickinson WP, Walunas TL, Nguyen AM, Fagnan LJ, Cykert S, Cohen DJ, Balasubramanaian BA, Fernald D, Gordon L, Kho A, Krist A, Miller W, Berry C, Duffy D, Nagykaldi Z. A Taxonomy for External Support for Practice Transformation. J Am Board Fam Med. 2021 Jan-Feb;34(1):32-39. doi: 10.3122/jabfm.2021.01.200225.
PubMed 33452080Sweeney SM, Hall JD, Ono SS, Gordon L, Cameron D, Hemler J, Solberg LI, Crabtree BF, Cohen DJ. Recruiting Practices for Change Initiatives Is Hard: Findings From EvidenceNOW. Am J Med Qual. 2018 May/Jun;33(3):246-252. doi: 10.1177/1062860617728791. Epub 2017 Sep 4.
PubMed 28868889Ono SS, Crabtree BF, Hemler JR, Balasubramanian BA, Edwards ST, Green LA, Kaufman A, Solberg LI, Miller WL, Woodson TT, Sweeney SM, Cohen DJ. Taking Innovation To Scale In Primary Care Practices: The Functions Of Health Care Extension. Health Aff (Millwood). 2018 Feb;37(2):222-230. doi: 10.1377/hlthaff.2017.1100.
PubMed 29401016Dorr DA, Cohen DJ, Adler-Milstein J. Data-Driven Diffusion Of Innovations: Successes And Challenges In 3 Large-Scale Innovative Delivery Models. Health Aff (Millwood). 2018 Feb;37(2):257-265. doi: 10.1377/hlthaff.2017.1133.
PubMed 29401031Hemler JR, Hall JD, Cholan RA, Crabtree BF, Damschroder LJ, Solberg LI, Ono SS, Cohen DJ. Practice Facilitator Strategies for Addressing Electronic Health Record Data Challenges for Quality Improvement: EvidenceNOW. J Am Board Fam Med. 2018 May-Jun;31(3):398-409. doi: 10.3122/jabfm.2018.03.170274.
PubMed 29743223Balasubramanian BA, Marino M, Cohen DJ, Ward RL, Preston A, Springer RJ, Lindner SR, Edwards S, McConnell KJ, Crabtree BF, Miller WL, Stange KC, Solberg LI. Use of Quality Improvement Strategies Among Small to Medium-Size US Primary Care Practices. Ann Fam Med. 2018 Apr;16(Suppl 1):S35-S43. doi: 10.1370/afm.2172.
PubMed 29632224Cohen DJ, Dorr DA, Knierim K, DuBard CA, Hemler JR, Hall JD, Marino M, Solberg LI, McConnell KJ, Nichols LM, Nease DE Jr, Edwards ST, Wu WY, Pham-Singer H, Kho AN, Phillips RL Jr, Rasmussen LV, Duffy FD, Balasubramanian BA. Primary Care Practices' Abilities And Challenges In Using Electronic Health Record Data For Quality Improvement. Health Aff (Millwood). 2018 Apr;37(4):635-643. doi: 10.1377/hlthaff.2017.1254.
PubMed 29608365Edwards ST, Marino M, Balasubramanian BA, Solberg LI, Valenzuela S, Springer R, Stange KC, Miller WL, Kottke TE, Perry CK, Ono S, Cohen DJ. Burnout Among Physicians, Advanced Practice Clinicians and Staff in Smaller Primary Care Practices. J Gen Intern Med. 2018 Dec;33(12):2138-2146. doi: 10.1007/s11606-018-4679-0. Epub 2018 Oct 1.
PubMed 30276654
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES)
- ClinicalTrials.gov ID
- NCT02560428
- Acronym / sponsor ID
- ESCALATES / 11482
- Conditions
- Program Evaluation
- Keywords
- Mixed Methods, Cardiovascular Health, Implementation Evaluation, Cardiovascular Prevention Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Texas, Rutgers University, HealthPartners Institute, University of Michigan, Case Western Reserve University
- Study start
- Apr 2015
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 25 Sep 2015 (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 approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.
Detailed description
The purpose of this study is to evaluate approximately eight different R18 grants that will test practice change interventions to improve cardiovascular disease (CVD) prevention screening. The investigators will collect and analyze quantitative data (context, process, and outcomes) to identify the most effective combinations of intervention strategies for various practice types in relation to practice structure, context, and organizational characteristics associated with change in outcomes. The investigators will collect qualitative data (observation, interviews, online diaries) from grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather documents and de-identified quantitative data from grantees.
Evidence clearly shows that many people do not receive guideline-concordant health care; this is true even for low cost treatments such as Aspirin prescribing, Blood pressure and Cholesterol control and Smoking cessation (the ABCS) known to prevent cardiovascular disease (CVD). In hospitals and integrated care systems with substantial resources, large quality improvement campaigns have been shown to increase adherence to guidelines by creating communities of learning that change behavior on a large scale. Agency for Healthcare Research and Quality (AHRQ) and the Patient Centered Outcomes Research Institute (PCORI) are partnering to launch a campaign to promote the improvement of guideline-based CVD preventive care in small primary care practices with limited resources and experience with quality improvement ("Implementation" RFA-HS-14-008). The practices for each of these R18 grants will be in a contiguous geographic region. This study will evaluate each of these R18 implementation grants.
The investigators' strategy is to conduct a prospective observational analysis to evaluate the effectiveness of the R18s ABCS quality improvement initiatives. To do this, the investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators will also gather de-identified quantitative data that the R18s collected.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include all R18 grantees
Key inclusion criteria (1 listed)
- All R18 grant awardees are included in the study.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| ESCALATESAlso: EvidenceNOWThe investigators collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators also gather de-identified quantitative data that the R18s collected. | Behavioural | – |
Primary outcome
Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period.
Time frame: Quarterly for 4 years
Acute myocardial infarction (AMI), ischemic vascular disease (IVD), percutaneous coronary interventions (PCI)
Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period.
Time frame: Quarterly for 4 years
Patients 18years and older and 85years or younger with at least one face to face visit and active diagnosis of essential hypertension at any time before the first date of month 7 of the measurement period and who did not (i) have an active diagnosis of pregnancy at any time during the measurement period; or (ii) have evidence of end stage renal disease, dialysis, or renal transplant before or during the measurement period
Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period.
Time frame: Quarterly for 4 years
Patients 21 and older with at least one face to face visit who have an active diagnosis of clinical atherosclerotic cardiovascular, LDL-C result >= 190mg/dL, aged 40 to 75years at the beginning of the measurement period with an active diagnosis of diabetes with the highest LDL-C result of 70 to 189mg/ dL and who (i) did not have adverse effect, allergy or intolerance to statin medication therapy; (ii) did not have an active diagnosis of pregnancy or breastfeeding; (iii) did not receive palliative care; (iv) did not have an active liver disease or hepatic disease of insufficiency; (v) did not have end stage renal disease; or (vi) did not have a most recent LDL-C results<70mg/dL for patients with a diabetes diagnosis who are not currently receiving statin medication therapy during the current measurement period or any time period.
Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user.
Time frame: Quarterly for 4 years
Patients 18years and older as of the first day of the measurement period with at least two visits during the measurement period
2 secondary outcomes
Practice capacity for change measured by adaptive reserve (AR)
Time frame: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum)
Practice capacity for quality improvement measured by CPCQ
Time frame: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum)
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 3 Jun 2024.
- Background: PubMed 27358078Cohen DJ, Balasubramanian BA, Gordon L, Marino M, Ono S, Solberg LI, Crabtree BF, Stange KC, Davis M, Miller WL, Damschroder LJ, McConnell KJ, Creswell J. A national evaluation of a dissemination and implementation initiative to enhance primary care practice capacity and improve cardiovascular disease care: the ESCALATES study protocol. Implement Sci. 2016 Jun 29;11(1):86. doi: 10.1186/s13012-016-0449-8.
- Background: PubMed 26577091Weiner BJ, Pignone MP, DuBard CA, Lefebvre A, Suttie JL, Freburger JK, Cykert S. Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol. Implement Sci. 2015 Nov 14;10:160. doi: 10.1186/s13012-015-0348-4.
- Background: PubMed 27377404Shelley DR, Ogedegbe G, Anane S, Wu WY, Goldfeld K, Gold HT, Kaplan S, Berry C. Testing the use of practice facilitation in a cluster randomized stepped-wedge design trial to improve adherence to cardiovascular disease prevention guidelines: HealthyHearts NYC. Implement Sci. 2016 Jul 4;11(1):88. doi: 10.1186/s13012-016-0450-2.
- Background: PubMed 28062823Kaufman A, Rhyne RL, Anastasoff J, Ronquillo F, Nixon M, Mishra S, Poola C, Page-Reeves J, Nkouaga C, Cordova C, Larson RS. Health Extension and Clinical and Translational Science: An Innovative Strategy for Community Engagement. J Am Board Fam Med. 2017 Jan 2;30(1):94-99. doi: 10.3122/jabfm.2017.01.160119.
- BackgroundReck J. Primary care provider burnout: implications for states & strategies for mitigation. National Academy for State Health Policy. 2017 Jan.
- Background: PubMed 28475721Solberg LI. What do we know and need to know about transforming primary care? Fam Pract. 2017 Aug 1;34(4):371-372. doi: 10.1093/fampra/cmx031. No abstract available.
- Background: PubMed 27737719Parchman ML, Fagnan LJ, Dorr DA, Evans P, Cook AJ, Penfold RB, Hsu C, Cheadle A, Baldwin LM, Tuzzio L. Study protocol for "Healthy Hearts Northwest": a 2 x 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. doi: 10.1186/s13012-016-0502-7.
- Background: PubMed 33452080Solberg LI, Kuzel A, Parchman ML, Shelley DR, Dickinson WP, Walunas TL, Nguyen AM, Fagnan LJ, Cykert S, Cohen DJ, Balasubramanaian BA, Fernald D, Gordon L, Kho A, Krist A, Miller W, Berry C, Duffy D, Nagykaldi Z. A Taxonomy for External Support for Practice Transformation. J Am Board Fam Med. 2021 Jan-Feb;34(1):32-39. doi: 10.3122/jabfm.2021.01.200225.
- Results publication: PubMed 28868889Sweeney SM, Hall JD, Ono SS, Gordon L, Cameron D, Hemler J, Solberg LI, Crabtree BF, Cohen DJ. Recruiting Practices for Change Initiatives Is Hard: Findings From EvidenceNOW. Am J Med Qual. 2018 May/Jun;33(3):246-252. doi: 10.1177/1062860617728791. Epub 2017 Sep 4.
- Results publication: PubMed 29401016Ono SS, Crabtree BF, Hemler JR, Balasubramanian BA, Edwards ST, Green LA, Kaufman A, Solberg LI, Miller WL, Woodson TT, Sweeney SM, Cohen DJ. Taking Innovation To Scale In Primary Care Practices: The Functions Of Health Care Extension. Health Aff (Millwood). 2018 Feb;37(2):222-230. doi: 10.1377/hlthaff.2017.1100.
- Results publication: PubMed 29401031Dorr DA, Cohen DJ, Adler-Milstein J. Data-Driven Diffusion Of Innovations: Successes And Challenges In 3 Large-Scale Innovative Delivery Models. Health Aff (Millwood). 2018 Feb;37(2):257-265. doi: 10.1377/hlthaff.2017.1133.
- Results publication: PubMed 29743223Hemler JR, Hall JD, Cholan RA, Crabtree BF, Damschroder LJ, Solberg LI, Ono SS, Cohen DJ. Practice Facilitator Strategies for Addressing Electronic Health Record Data Challenges for Quality Improvement: EvidenceNOW. J Am Board Fam Med. 2018 May-Jun;31(3):398-409. doi: 10.3122/jabfm.2018.03.170274.
- National evaluation's public-facing websiteLink provided by the sponsor.
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Valid MeSH Conditiongs
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.
Debbie Cohen, PhD principal investigator
OHSU, Department of Family Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Program Evaluation, run by Oregon Health and Science University.
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 1 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period. (time frame: Quarterly for 4 years). The study lists 4 primary outcomes in all. 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 NCT02560428, which also lists 25 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 3 Jun 2024.