Cardiovascular DiseasesMHNCT04047147
Evaluation of the Million Hearts CVD Risk Reduction Model
An observational study of Cardiovascular Diseases, run by Mathematica Policy Research, Inc..
Trial summary
The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model, run by the Centers for Medicare \& Medicaid Services (CMS), seeks to improve cardiovascular care by providing incentives and supports for health care practitioners to engage in patient CVD risk calculation and population-level CVD risk management. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Enrollment in the Million Hearts CVD Risk Reduction Model
- How many people
- 210,000 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2017to 31 Dec 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 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is a census of Medicare fee-for-service beneficiaries who were enrolled by providers (physicians, nurse practitioners, or physician assistants) in the intervention and control organizations. Providers enroll a beneficiary when they have an office visit with a patient and submit to CMS all of the CVD risk data needed to generate a risk score that is current as of that visit date. Providers submit these data to CMS via a registry-called the Million Hearts Model Data Registry-designed specifically for this purpose. Beneficiaries will be included in the study population if they meet the eligibility criteria. Following an intent-to-treat principle, we will keep beneficiaries in the sample for as long as they are alive and observable in Medicare FFS claims data (the primary source for study outcomes), whether or not they continue to receive clinical services from the participating organizations.
Who may be able to join
- Ages 40-79 as of enrollment in the program
- Enrolled in Medicare Part A and B
- Some analyses will include only those with a 10-year predicted CVD risk exceeding 30 percent (high risk). Others will include those with a 10-year predicted CVD risk exceeding 15 percent (high and medium risk).
- Some secondary analyses related to medication use will also be restricted to those enrolled in Medicare Part D
Who cannot join
- Have had a heart or stroke previously
- Have end-stage renal disease
- Currently enrolled in hospice care
About this study
The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model, run by the Centers for Medicare \& Medicaid Services (CMS), seeks to improve cardiovascular care by providing incentives and supports for health care practitioners to engage in patient CVD risk calculation and population-level CVD risk management. CMS enrolled organizations throughout the United States, randomly assigning half to the intervention and half to a control group. This study is an evaluation of the model and will assess the model impacts on patient outcomes, changes in CVD care processes, and implementation challenges and successes.
Read the detailed description
In January 2017, the Centers for Medicare \& Medicaid Services (CMS) launched the Million Hearts Cardiovascular Disease (CVD) Risk Reduction model, designed to reduce heart attacks and strokes among Medicare fee for-service (FFS) beneficiaries. CMS is testing the Million Hearts CVD model over five years among more than 400 participating organizations, with half randomly assigned to the intervention and half to a control group. These organizations include primary care practices, specialty/multispecialty practices, health centers, and hospital outpatient departments. The intervention organizations are expected to:
- Risk stratify all of their eligible Medicare FFS beneficiaries, using the American College of Cardiology/American Heart Association (ACC/AHA) calculator to estimate each eligible beneficiary's risk of having a heart attack or stroke over the next 10 years. Beneficiaries are eligible if they are ages 40-79 as of enrollment in the program, have not had a heart attack or stroke, are enrolled in Medicare Part A and B, do not have end-stage renal disease, and are not receiving hospice benefits. Beneficiaries with a CVD risk exceeding 30 percent are considered high risk, whereas those with a risk from 15-30 percent are medium risk. All others are low risk.
- Provide cardiovascular care management to high-risk beneficiaries--which includes discussing with patients different options for reducing CVD risk, developing a care plan, and following up with patients at least twice a year (any mode) to assess and encourage progress on the care plan, and annual in-person visits to reassess risk and revise care plans.
- Collect and report clinical data to CMS via the Million Hearts Model Data Registry.
- Participate in learning system activities, including webinars and videoconferences, designed to spread effective strategies for implementing the model.
CMS supports the intervention organizations with payments for risk stratification, cardiovascular management, and risk reduction. Participating organizations receive payments for each eligible beneficiary they risk stratify. In the first model year, the cardiovascular management fees are fixed per beneficiary per month (PBPM) for each high-risk enrollee. In model year 2 and later, CMS is replacing the cardiovascular management fees with risk reduction payments that are scaled to the organization's performance in reducing 10-year predicted risk among their beneficiaries who were high-risk at initial enrollment. To support the model's evaluation, CMS is also paying control organizations to collect and report clinical data on their eligible Medicare FFS beneficiaries, but these organizations are not asked to calculate CVD risk scores or otherwise change their clinical care.
The primary goal of the investigators is to evaluate the impact of this model on first-time heart attacks and strokes and CVD-related spending among high CVD risk Medicare FFS beneficiaries, comparing beneficiaries in intervention practices with beneficiaries in control practices. Using Medicare Part A, B, and D administrative claims data, investigators also plan to evaluate the impact of the model on beneficiary mortality, CVD service utilization, and CVD-related medication use. The investigators will also use survey data from providers to identify changes in CVD-related knowledge, behaviors, and care delivery.
- Conditions
- Cardiovascular Diseases
- Being tested
- Enrollment in the Million Hearts CVD Risk Reduction Model, Enrollment in control provider organizations
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enrollment in the Million Hearts CVD Risk Reduction ModelOther
The intervention is at a provider organization level and all eligible beneficiaries enrolled by participants will be considered exposed. Intervention organizations receive payments to:
- Risk stratify eligible Medicare FFS beneficiaries
- Provide CVD care management to high-risk beneficiaries
- Collect and report clinical data to CMS via the Million Hearts Data Registry and participate in learning system activities
Participating organizations receive payments for each eligible beneficiary they risk stratify. In model year 1, the organizations receive a fixed payment per beneficiary per month to provide cardiovascular management. In model years 2-5, the organizations receive a risk reduction payment that is scaled based on reductions in 10-year predicted risk scores among their cohort of high-risk beneficiaries.
Enrollment in control provider organizationsOther
Control organizations receive payments to collect and report clinical data on their eligible Medicare FFS beneficiaries, but are not asked to calculate CVD risk scores or otherwise change their clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment in the Million Hearts CVD Risk Reduction Model | Eligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to participate in the Million Hearts CVD Risk Reduction Model intervention. Receives: Other: Enrollment in the Million Hearts CVD Risk Reduction Model | |
| Enrollment in control provider organizations | Eligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to the control group. Receives: Other: Enrollment in control provider organizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of heart attacks and strokes among high risk
Incidence of first-time heart attack and stroke among high CVD risk enrollees
Measured: 5 years
Incidence of heart attacks and strokes among high and medium risk
Incidence of first-time heart attack and stroke among high and medium CVD risk enrollees
Measured: 5 years
CVD-related spending among high risk
Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees
Measured: 5 years
CVD-related spending among high and medium risk
Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees
Measured: 5 years
Secondary outcomes (13)
Rate of all-cause mortality
Mortality rate from any cause, analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 5 years
Change in 10-year predicted CVD risk
Change in 10-year predicted risk of hearts attack or stroke between baseline and reassessment visits, with predicted risk estimated in percentage points using the Million Hearts Longitudinal Atherosclerotic CVD Risk Assessment Tool. Predicted CVD risk ranges from 0 to 100 percent and larger predicted CVD risk represent worse outcomes. Measure will be analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined.
Measured: 3 years
Spending, without model payments
Medicare Part A and B spending (in dollars per person per quarter, without including additional payments associated with the Million Hearts CVD Risk Reduction Model), analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 5 years
Spending, with model payments
Medicare Part A and B spending and additional payments (in dollars per person per quarter) associated with the Million Hearts CVD Risk Reduction Model, among high and medium CVD risk enrollees
Measured: 5 years
Number of CVD-related hospitalizations
Hospitalizations for heart attack, stroke, and other cardiovascular disease (in number per 1,000 people per quarter), analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 5 year
Number of CVD-related emergency department visits
Number of outpatient emergency department visits for heart attack, stroke, and other cardiovascular disease (in number per 1,000 people per quarter), analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 5 years
Number of Million Hearts office visits
Number of office visits with a Million Hearts-participating provider (in number per 1,000 people per quarter), analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 5 years
Percent of eligible beneficiaries using statins
Percent of beneficiaries with Medicare Part D coverage and elevated LDL cholesterol at baseline who initiated or intensified statins to lower cholesterol within one year of baseline. This will also be analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 1 year
Percent of eligible beneficiaries using anti-hypertensive medications
Percent of beneficiaries with Medicare Part D coverage and elevated blood pressure at baseline who Initiated or intensified medications to lower blood pressure within one year of baseline. This will also be analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 1 year
Percent of eligible beneficiaries using either statins or anti-hypertensive medications
Percent of beneficiaries with Medicare Part D coverage and either LDL cholesterol or elevated blood pressure at baseline who initiated or intensified statins to lower cholesterol or medications to lower blood pressure within one year of baseline. This will also be analyzed separately for just high CVD risk enrollees and for high and medium CVD risk enrollees combined
Measured: 1 year
Proportion of providers reporting they calculate CVD risk scores for at least half of their Medicare beneficiaries
Proportion of providers who self-report that they calculate a cardiovascular risk score for at least 50% of their Medicare beneficiary panel. Based on responses to the Million Hearts Provider Survey. A greater percent of providers calculating risk scores is a better outcome.
Measured: 5 years
Proportion of providers reporting they review CVD risk scores more consistently
Proportion of providers who self-report that they review CVD risk scores more consistently now than before the start of the Million Hearts model. Based on responses to the Million Hearts Provider Survey. A greater percent of providers reporting that they review risk scores more consistently is a better outcome.
Measured: 5 years
Proportion of providers reporting follow-up with high-risk beneficiaries through any mode to monitor plans to reduce risk at least every three months
Proportion of providers who self-report that once they have identified Medicare beneficiaries as having high CVD risk, that their practice follows up with the beneficiaries through any mode (e.g., office visits, telephone calls, emails, or letters) to monitor plans to reduce risk. Based on responses to the Million Hearts Provider Survey. A greater percent of providers reporting that they follow up with high-risk beneficiaries is a better outcome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start3 Jan 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, RAND
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047147
- Sponsor's protocol ID
- MPR50496
- Acronym
- MH
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blue L, Kranker K, Markovitz AR, Powell RE, Williams MV, Pu J, Magid DJ, McCall N, Steiner A, Stewart KA, Rollison JM, Markovich P, Peterson GG. Effects of the Million Hearts Model on Myocardial Infarctions, Strokes, and Medicare Spending: A Randomized Clinical Trial. JAMA. 2023 Oct 17;330(15):1437-1447. doi: 10.1001/jama.2023.19597.
PubMed 37847273
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Million Hearts CVD Risk Reduction Model
- ClinicalTrials.gov ID
- NCT04047147
- Acronym / sponsor ID
- MH / MPR50496
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210,000 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, RAND
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Aug 2019 (actual)
- 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 Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model, run by the Centers for Medicare \& Medicaid Services (CMS), seeks to improve cardiovascular care by providing incentives and supports for health care practitioners to engage in patient CVD risk calculation and population-level CVD risk management. CMS enrolled organizations throughout the United States, randomly assigning half to the intervention and half to a control group. This study is an evaluation of the model and will assess the model impacts on patient outcomes, changes in CVD care processes, and implementation challenges and successes.
Detailed description
In January 2017, the Centers for Medicare \& Medicaid Services (CMS) launched the Million Hearts Cardiovascular Disease (CVD) Risk Reduction model, designed to reduce heart attacks and strokes among Medicare fee for-service (FFS) beneficiaries. CMS is testing the Million Hearts CVD model over five years among more than 400 participating organizations, with half randomly assigned to the intervention and half to a control group. These organizations include primary care practices, specialty/multispecialty practices, health centers, and hospital outpatient departments. The intervention organizations are expected to:
- Risk stratify all of their eligible Medicare FFS beneficiaries, using the American College of Cardiology/American Heart Association (ACC/AHA) calculator to estimate each eligible beneficiary's risk of having a heart attack or stroke over the next 10 years. Beneficiaries are eligible if they are ages 40-79 as of enrollment in the program, have not had a heart attack or stroke, are enrolled in Medicare Part A and B, do not have end-stage renal disease, and are not receiving hospice benefits. Beneficiaries with a CVD risk exceeding 30 percent are considered high risk, whereas those with a risk from 15-30 percent are medium risk. All others are low risk.
- Provide cardiovascular care management to high-risk beneficiaries--which includes discussing with patients different options for reducing CVD risk, developing a care plan, and following up with patients at least twice a year (any mode) to assess and encourage progress on the care plan, and annual in-person visits to reassess risk and revise care plans.
- Collect and report clinical data to CMS via the Million Hearts Model Data Registry.
- Participate in learning system activities, including webinars and videoconferences, designed to spread effective strategies for implementing the model.
CMS supports the intervention organizations with payments for risk stratification, cardiovascular management, and risk reduction. Participating organizations receive payments for each eligible beneficiary they risk stratify. In the first model year, the cardiovascular management fees are fixed per beneficiary per month (PBPM) for each high-risk enrollee. In model year 2 and later, CMS is replacing the cardiovascular management fees with risk reduction payments that are scaled to the organization's performance in reducing 10-year predicted risk among their beneficiaries who were high-risk at initial enrollment. To support the model's evaluation, CMS is also paying control organizations to collect and report clinical data on their eligible Medicare FFS beneficiaries, but these organizations are not asked to calculate CVD risk scores or otherwise change their clinical care.
The primary goal of the investigators is to evaluate the impact of this model on first-time heart attacks and strokes and CVD-related spending among high CVD risk Medicare FFS beneficiaries, comparing beneficiaries in intervention practices with beneficiaries in control practices. Using Medicare Part A, B, and D administrative claims data, investigators also plan to evaluate the impact of the model on beneficiary mortality, CVD service utilization, and CVD-related medication use. The investigators will also use survey data from providers to identify changes in CVD-related knowledge, behaviors, and care delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrollment in the Million Hearts CVD Risk Reduction Model | – | Other: Enrollment in the Million Hearts CVD Risk Reduction ModelEligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to participate in the Million Hearts CVD Risk Reduction Model intervention. |
| Enrollment in control provider organizations | – | Other: Enrollment in control provider organizationsEligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to the control group. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a census of Medicare fee-for-service beneficiaries who were enrolled by providers (physicians, nurse practitioners, or physician assistants) in the intervention and control organizations. Providers enroll a beneficiary when they have an office visit with a patient and submit to CMS all of the CVD risk data needed to generate a risk score that is current as of that visit date. Providers submit these data to CMS via a registry-called the Million Hearts Model Data Registry-designed specifically for this purpose. Beneficiaries will be included in the study population if they meet the eligibility criteria. Following an intent-to-treat principle, we will keep beneficiaries in the sample for as long as they are alive and observable in Medicare FFS claims data (the primary source for study outcomes), whether or not they continue to receive clinical services from the participating organizations.
Key inclusion criteria (4 listed)
- Ages 40-79 as of enrollment in the program
- Enrolled in Medicare Part A and B
- Some analyses will include only those with a 10-year predicted CVD risk exceeding 30 percent (high risk). Others will include those with a 10-year predicted CVD risk exceeding 15 percent (high and medium risk).
- Some secondary analyses related to medication use will also be restricted to those enrolled in Medicare Part D
Key exclusion criteria (3 listed)
- Have had a heart or stroke previously
- Have end-stage renal disease
- Currently enrolled in hospice care
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 |
|---|---|---|
| Enrollment in the Million Hearts CVD Risk Reduction ModelThe intervention is at a provider organization level and all eligible beneficiaries enrolled by participants will be considered exposed. Intervention organizations receive payments to: * Risk stratify eligible Medicare FFS beneficiaries * Provide CVD care management to high-risk beneficiaries * Collect and report clinical data to CMS via the Million Hearts Data Registry and participate in learning system activities Participating organizations receive payments for each eligible beneficiary they risk stratify. In model year 1, the organizations receive a fixed payment per beneficiary per month to provide cardiovascular management. In model years 2-5, the organizations receive a risk reduction payment that is scaled based on reductions in 10-year predicted risk scores among their cohort of high-risk beneficiaries. | Other | Enrollment in the Million Hearts CVD Risk Reduction Model |
| Enrollment in control provider organizationsControl organizations receive payments to collect and report clinical data on their eligible Medicare FFS beneficiaries, but are not asked to calculate CVD risk scores or otherwise change their clinical care. | Other | Enrollment in control provider organizations |
Primary outcome
Incidence of heart attacks and strokes among high risk
Time frame: 5 years
Incidence of first-time heart attack and stroke among high CVD risk enrollees
Incidence of heart attacks and strokes among high and medium risk
Time frame: 5 years
Incidence of first-time heart attack and stroke among high and medium CVD risk enrollees
CVD-related spending among high risk
Time frame: 5 years
Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees
CVD-related spending among high and medium risk
Time frame: 5 years
Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees
13 secondary outcomes
Rate of all-cause mortality
Time frame: 5 years
Change in 10-year predicted CVD risk
Time frame: 3 years
Spending, without model payments
Time frame: 5 years
Spending, with model payments
Time frame: 5 years
Number of CVD-related hospitalizations
Time frame: 5 year
Number of CVD-related emergency department visits
Time frame: 5 years
Number of Million Hearts office visits
Time frame: 5 years
Percent of eligible beneficiaries using statins
Time frame: 1 year
Percent of eligible beneficiaries using anti-hypertensive medications
Time frame: 1 year
Percent of eligible beneficiaries using either statins or anti-hypertensive medications
Time frame: 1 year
Proportion of providers reporting they calculate CVD risk scores for at least half of their Medicare beneficiaries
Time frame: 5 years
Proportion of providers reporting they review CVD risk scores more consistently
Time frame: 5 years
Proportion of providers reporting follow-up with high-risk beneficiaries through any mode to monitor plans to reduce risk at least every three months
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 37847273Blue L, Kranker K, Markovitz AR, Powell RE, Williams MV, Pu J, Magid DJ, McCall N, Steiner A, Stewart KA, Rollison JM, Markovich P, Peterson GG. Effects of the Million Hearts Model on Myocardial Infarctions, Strokes, and Medicare Spending: A Randomized Clinical Trial. JAMA. 2023 Oct 17;330(15):1437-1447. doi: 10.1001/jama.2023.19597.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Mathematica Policy Research, Inc..
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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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?
Results are not available in the source record.
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?
Incidence of heart attacks and strokes among high risk (time frame: 5 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 NCT04047147, 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 6 Aug 2019.