Cardiovascular Factor RiskSCIP1NCT02375815
Statin Choice Decision Aid Implementation First Phase
A study testing Statin Choice Implementation in people with Cardiovascular Factor Risk, run by Mayo Clinic at 4 sites in United States.
Trial summary
This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Factor Risk
- What is being tested?
- Statin Choice Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects of the Mayo Clinic Care Network
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kootenai Health
Coeur d'Alene, Idaho, 83814
Altru Health System
Grand Forks, North Dakota, 58206
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mosaic Life Care
Saint Joseph, Missouri, 64506
About this study
Official title: The Statin Choice Implementation Project: Phase 1
This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the potential of this model, the investigators will conduct a multi-year study comprising 3 phases. This proposal represents the first of these phases.
- Conditions
- Cardiovascular Factor Risk
- Being tested
- Statin Choice Implementation
- Keywords
- statin, decision aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin Choice ImplementationOther
| Study group | Role | What they receive |
|---|---|---|
| Statin Choice Implementation | Experimental | Not described Receives: Other: Statin Choice Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Implementation of Statin Choice Decision Aid (SCDA), as indicated by the cumulative reach (% usage in appropriate primary care consultations) across all 3 health systems (as measured by EMR-based calculations).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionMar 2017
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 Factor RiskStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor Montori, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375815
- Sponsor's protocol ID
- 14-006048
- Acronym
- SCIP1
- Status last verified
- Mar 2017
- First submitted
- 16 Feb 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Leppin AL, Boehmer KR, Branda ME, Shah ND, Hargraves I, Dick S, Elwyn G, Ting HH, Ye S, Gilles R, Abbas M, Alexander A, Montori VM. Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model. BMC Health Serv Res. 2019 Apr 24;19(1):249. doi: 10.1186/s12913-019-4055-8.
PubMed 31018840
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Statin Choice Implementation Project: Phase 1
- ClinicalTrials.gov ID
- NCT02375815
- Acronym / sponsor ID
- SCIP1 / 14-006048
- Conditions
- Cardiovascular Factor Risk
- Keywords
- statin, decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Mar 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.
This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the potential of this model, the investigators will conduct a multi-year study comprising 3 phases. This proposal represents the first of these phases.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Statin Choice Implementation | Experimental | Other: Statin Choice Implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Statin Choice Implementation | Other | Statin Choice Implementation |
Primary outcome
Effective Implementation of Statin Choice Decision Aid (SCDA), as indicated by the cumulative reach (% usage in appropriate primary care consultations) across all 3 health systems (as measured by EMR-based calculations).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 31018840Leppin AL, Boehmer KR, Branda ME, Shah ND, Hargraves I, Dick S, Elwyn G, Ting HH, Ye S, Gilles R, Abbas M, Alexander A, Montori VM. Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model. BMC Health Serv Res. 2019 Apr 24;19(1):249. doi: 10.1186/s12913-019-4055-8.
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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.
Victor Montori, MD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin Choice Implementation in people with Cardiovascular Factor Risk, run by Mayo Clinic at 4 sites 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?
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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Effective Implementation of Statin Choice Decision Aid (SCDA), as indicated by the cumulative reach (% usage in appropriate primary care consultations) across all 3 health systems (as measured by EMR-based calculations). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375815, 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 24 Mar 2017.