Chronic DiseaseNCT03062670
Team-Based Delivery of Care in Outpatient Settings
A study testing Retreat in people with Chronic Disease, run by Mayo Clinic at 10 sites in United States.
Trial summary
Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Retreat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 10 sitesUnited States
- Study dates
- 31 Jan 2017to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year old adult
- member of Mayo care team in the Midwest
Who cannot join
- -Unable to provide consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic Health System in Austin
Austin, Minnesota, 55912
Mayo Clinic Health System in Cannon Falls
Cannon Falls, Minnesota, 55009
Mayo Clinic Health System in Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic Health System in Lake City
Lake City, Minnesota, 55041
Mayo Clinic Health System in Mankato
Mankato, Minnesota, 56001
Mayo Clinic Health System in Owatonna
Owatonna, Minnesota, 55060
Mayo Clinic Health System in Red Wing
Red Wing, Minnesota, 55066
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Team-Based Delivery of Care in Outpatient Settings: An Experimental Investigation
Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. This approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.
- Conditions
- Chronic Disease
- Being tested
- Retreat
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetreatOther
Full day off-site training session
| Study group | Role | What they receive |
|---|---|---|
| Retreat | Experimental | A full day off-site training session Receives: Other: Retreat |
| Control | No intervention | Care teams normal process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in team cohesion
Survey with 5 point likert scale
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start31 Jan 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R. Rushlow, Mayo Clinic
- Investigators
- David R Rushlow, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062670
- Sponsor's protocol ID
- 16-010146
- Status last verified
- Jan 2019
- First submitted
- 20 Feb 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lampman MA, Chandrasekaran A, Branda ME, Tumerman MD, Ward P, Staats B, Johnson T, Giblon R, Shah ND, Rushlow DR. Optimizing Huddle Engagement Through Leadership and Problem Solving Within Primary Care: Results from a Cluster-Randomized Trial. J Gen Intern Med. 2021 Aug;36(8):2292-2299. doi: 10.1007/s11606-020-06487-6. Epub 2021 Jan 26.
PubMed 33501530Branda ME, Chandrasekaran A, Tumerman MD, Shah ND, Ward P, Staats BR, Lewis TM, Olson DK, Giblon R, Lampman MA, Rushlow DR. Optimizing huddle engagement through leadership and problem-solving within primary care: A study protocol for a cluster randomized trial. Trials. 2018 Oct 4;19(1):536. doi: 10.1186/s13063-018-2847-5.
PubMed 30286798
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team-Based Delivery of Care in Outpatient Settings: An Experimental Investigation
- ClinicalTrials.gov ID
- NCT03062670
- Acronym / sponsor ID
- 16-010146
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 23 Feb 2017 (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.
Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. This approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retreat | Experimental | Other: RetreatA full day off-site training session |
| Control | No intervention | –Care teams normal process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 year old adult
- member of Mayo care team in the Midwest
Key exclusion criteria (1 listed)
- -Unable to provide 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 |
|---|---|---|
| RetreatFull day off-site training session | Other | Retreat |
Primary outcome
Change in team cohesion
Time frame: Change from baseline to 6 months
Survey with 5 point likert scale
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 11 Jan 2019.
- Derived from this study: PubMed 33501530Lampman MA, Chandrasekaran A, Branda ME, Tumerman MD, Ward P, Staats B, Johnson T, Giblon R, Shah ND, Rushlow DR. Optimizing Huddle Engagement Through Leadership and Problem Solving Within Primary Care: Results from a Cluster-Randomized Trial. J Gen Intern Med. 2021 Aug;36(8):2292-2299. doi: 10.1007/s11606-020-06487-6. Epub 2021 Jan 26.
- Derived from this study: PubMed 30286798Branda ME, Chandrasekaran A, Tumerman MD, Shah ND, Ward P, Staats BR, Lewis TM, Olson DK, Giblon R, Lampman MA, Rushlow DR. Optimizing huddle engagement through leadership and problem-solving within primary care: A study protocol for a cluster randomized trial. Trials. 2018 Oct 4;19(1):536. doi: 10.1186/s13063-018-2847-5.
- 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.
David R Rushlow, MD study director
Mayo Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retreat in people with Chronic Disease, run by Mayo Clinic at 10 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 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Change in team cohesion (time frame: Change from baseline to 6 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 NCT03062670, which also lists 2 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 11 Jan 2019.