Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, OsteoporosisNCT02136199
Use of Decision Aids in Clinical Encounters
A study testing Active Implementation of ShareEBM Toolkit and Passive Dissemination of Share EBM in people with Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, Osteoporosis, run by Mayo Clinic at 12 sites in United States.
Trial summary
The active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, Osteoporosis
- What is being tested?
- Active Implementation of ShareEBM Toolkit and Passive Dissemination of Share EBM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2014to May 2016
- 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
Who may be able to join
- Practices meeting the following criteria will be deemed eligible for the study if they have:
- At least 2 primary care clinicians committed to participate in the study. Clinicians are defined as any healthcare professional providing patient care (i.e., physicians, nurse practitioners, physician assistants, diabetes educators)
- A designated site champion and support staff that can provide the support needed to conduct the study
- An IRB approval from their institution or are covered under Mayo Clinic IRB
- Leadership is committed to this research and has endorsed the study
- Any clinician caring for patients with a chronic condition and who has opportunities to discuss medication management with their patients will be deemed eligible
Who cannot join
- Major barriers to participating or to providing informed consent
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Baldwin Area Medical Center, Inc.
Baldwin, Wisconsin, 54002
Park Nicollet- Brookdale
Brooklyn Center, Minnesota, 55430
Ridgeview Medical Center
Delano, Minnesota, 55328
Essentia Health-Lakeside Clinic
Duluth, Minnesota, 55804
Fairview Clinic-Eagan
Eagan, Minnesota, 55122
Park Nicollet-Golden Valley
Golden Valley, Minnesota, 55427
Essentia Hermantown Clinic
Hermantown, Minnesota, 55811
Hudson Physicians S.C.
Hudson, Wisconsin, 54016
Native American Community Clinic
Minneapolis, Minnesota, 55404
Community Health Service, Inc.
Rochester, Minnesota, 55904
Mayo Clinic
Rochester, Minnesota, 55905
Fairview Medical-Rosemount
Rosemount, Minnesota, 55068
About this study
Official title: Patient-centered Dissemination of Evidence-based Medicine: Share EBM
The active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen.
The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with expertise in large-scale practice improvement at the state and national level. Largely funded by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into practice, through clinical practice guidelines, shared decision making, and practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a sustainable and innovative approach to the dissemination of evidence-based health information at the point of care.
The objective of the current study is therefore to leverage the expertise of these two organizations to compare the impact of an active to a passive dissemination and implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate evidence-based information through the use of decision aids during encounters. The overall purpose of the qualitative evaluation is to understand why decision aids were used more or less in certain practices and what factors contributed to or hindered this uptake.
- Being tested
- Active Implementation of ShareEBM Toolkit, Passive Dissemination of Share EBM
- Medical subject headings
- Diabetes Mellitus, Depression, Cardiovascular Diseases, Hypercholesterolemia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Implementation of ShareEBM ToolkitOther
Passive Dissemination of Share EBMOther
| Study group | Role | What they receive |
|---|---|---|
| Active Implementation of Share EBM Toolkit | Other | Investigators led implementation of tailored activities and tactics (Shared EBM Toolkit) designed to promote the use of the decision aids in clinical encounters (i.e. journal clubs, value map streaming). Receives: Other: Active Implementation of ShareEBM Toolkit |
| Passive Implementation of Share EBM Toolkit | Other | Locally supported dissemination of Shared EBM Toolkit designed to promote the use of the decision aids in clinical encounters. Receives: Other: Passive Dissemination of Share EBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use of decision aids in clinical encounters by weekly reports
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, OsteoporosisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT02136199
- Sponsor's protocol ID
- 14-002055
- Status last verified
- May 2016
- First submitted
- 24 Mar 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Dissemination of Evidence-based Medicine: Share EBM
- ClinicalTrials.gov ID
- NCT02136199
- Acronym / sponsor ID
- 14-002055
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 2014 (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 active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen.
The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with expertise in large-scale practice improvement at the state and national level. Largely funded by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into practice, through clinical practice guidelines, shared decision making, and practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a sustainable and innovative approach to the dissemination of evidence-based health information at the point of care.
The objective of the current study is therefore to leverage the expertise of these two organizations to compare the impact of an active to a passive dissemination and implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate evidence-based information through the use of decision aids during encounters. The overall purpose of the qualitative evaluation is to understand why decision aids were used more or less in certain practices and what factors contributed to or hindered this uptake.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Implementation of Share EBM Toolkit | Other | Other: Active Implementation of ShareEBM ToolkitInvestigators led implementation of tailored activities and tactics (Shared EBM Toolkit) designed to promote the use of the decision aids in clinical encounters (i.e. journal clubs, value map streaming). |
| Passive Implementation of Share EBM Toolkit | Other | Other: Passive Dissemination of Share EBMLocally supported dissemination of Shared EBM Toolkit designed to promote the use of the decision aids in clinical encounters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Practices meeting the following criteria will be deemed eligible for the study if they have:
- Any clinician caring for patients with a chronic condition and who has opportunities to discuss medication management with their patients will be deemed eligible
Key exclusion criteria (1 listed)
- Major barriers to participating or to providing informed consent
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 |
|---|---|---|
| Active Implementation of ShareEBM Toolkit | Other | Active Implementation of Share EBM Toolkit |
| Passive Dissemination of Share EBM | Other | Passive Implementation of Share EBM Toolkit |
Primary outcome
Frequency of use of decision aids in clinical encounters by weekly reports
Time frame: up to 1 year
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 May 2016.
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Implementation of ShareEBM Toolkit and Passive Dissemination of Share EBM in people with Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, Osteoporosis, run by Mayo Clinic at 12 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?
The sponsor lists 6 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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Frequency of use of decision aids in clinical encounters by weekly reports (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2016.