- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06465667
Improving Engagement With a Process Measure Dashboard Through Precision Feedback
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Michigan Urological Surgery Improvement Collaborative (MUSIC) is a state-wide, physician-led quality improvement collaborative comprised of over 40 urology practices representing varied practice sites within Michigan and nationally, designed to evaluate and improve the quality of urologic care.
A recently identified area for quality improvement within MUSIC is avoidance of placing ureteral stents following uncomplicated ureteroscopy and lithotripsy for kidney stones. Such unnecessary stents do not measurably increase post-operative safety, but rather have been shown to contribute to unnecessary emergency department visits. This process measure (stent omission after uncomplicated ureteroscopy) is the subject matter for the dashboard and will serve as the focus of precision feedback.
The study team hypothesizes that a behavior change intervention bundle consisting of "precision feedback" along with communication strategies to simplify access to feedback will increase dashboard engagement (measured via click-through rate and dashboard logins) compared with standard "one size fits most" e-mail messages. Knowledge gained from this study will inform the development of other precision feedback programs within our urology quality improvement collaborative (MUSIC), and provide a framework for rapid, pragmatic trials for small to mid-sized collaborative quality initiatives nationally.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Urologists participating in MUSIC that were in the top one hundred individuals in annual case volume from 2023 for "pre-stented ureteroscopy", the case for which the dashboard contents are most relevant.
Exclusion Criteria:
- Urologists that are not in the top one hundred individuals in annual "pre-stented ureteroscopy" case volume, urologists in the study team, or that opt out from the study at the individual or site level.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 dashboard (3 months) then dashboard with Precision feedback (12 months)
Months 0-3 dashboard only, months 3-15 months dashboard with Precision feedback.
|
The Dashboard intervention, representing current standard of care, will consist of a standard e-mail message with a link to the dashboard and text explanation.
No performance data will be included in the e-mail, and links will not be monitored for clickthrough with repeat e-mail.
The experimental intervention, precision feedback e-mail messaging, will consist of an e-mail with a link to the dashboard along with tailored information about a participant's performance in the quality process measure of interest.
For example, e-mail subject lines may read "You have room for improvement in stent omission," accompanied by a visual display in the body of the e-mail showing a participant's performance relative to a top performing peer.
The behavior change intervention delivery component will also involve modifications to existing procedures.
Namely, performance feedback will be reported directly in the e-mail as either plain text, or an embedded or attached image with graphed data.
|
|
Experimental: Group 2 dashboard (6 months) then dashboard with Precision feedback (6 months)
Months 0-6 dashboard only, months 6-15 months dashboard with Precision feedback.
|
The Dashboard intervention, representing current standard of care, will consist of a standard e-mail message with a link to the dashboard and text explanation.
No performance data will be included in the e-mail, and links will not be monitored for clickthrough with repeat e-mail.
The experimental intervention, precision feedback e-mail messaging, will consist of an e-mail with a link to the dashboard along with tailored information about a participant's performance in the quality process measure of interest.
For example, e-mail subject lines may read "You have room for improvement in stent omission," accompanied by a visual display in the body of the e-mail showing a participant's performance relative to a top performing peer.
The behavior change intervention delivery component will also involve modifications to existing procedures.
Namely, performance feedback will be reported directly in the e-mail as either plain text, or an embedded or attached image with graphed data.
|
|
Experimental: Group 3 dashboard (9 months) then dashboard with Precision feedback (6 months)
Months 0-9 dashboard only, months 9-15 months dashboard with Precision feedback.
|
The Dashboard intervention, representing current standard of care, will consist of a standard e-mail message with a link to the dashboard and text explanation.
No performance data will be included in the e-mail, and links will not be monitored for clickthrough with repeat e-mail.
The experimental intervention, precision feedback e-mail messaging, will consist of an e-mail with a link to the dashboard along with tailored information about a participant's performance in the quality process measure of interest.
For example, e-mail subject lines may read "You have room for improvement in stent omission," accompanied by a visual display in the body of the e-mail showing a participant's performance relative to a top performing peer.
The behavior change intervention delivery component will also involve modifications to existing procedures.
Namely, performance feedback will be reported directly in the e-mail as either plain text, or an embedded or attached image with graphed data.
|
|
Experimental: Group 4 dashboard (12 months) then dashboard with Precision feedback (3 months)
Months 0-12 dashboard only, months 12-15 months dashboard with Precision feedback.
|
The Dashboard intervention, representing current standard of care, will consist of a standard e-mail message with a link to the dashboard and text explanation.
No performance data will be included in the e-mail, and links will not be monitored for clickthrough with repeat e-mail.
The experimental intervention, precision feedback e-mail messaging, will consist of an e-mail with a link to the dashboard along with tailored information about a participant's performance in the quality process measure of interest.
For example, e-mail subject lines may read "You have room for improvement in stent omission," accompanied by a visual display in the body of the e-mail showing a participant's performance relative to a top performing peer.
The behavior change intervention delivery component will also involve modifications to existing procedures.
Namely, performance feedback will be reported directly in the e-mail as either plain text, or an embedded or attached image with graphed data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clickthrough rate to the online dashboard
Time Frame: Every 3 months up to 15 months
|
Clickthrough is defined as a link ever being clicked in the three months following e-mail send date, at which point in time a new e-mail will be sent.
Clickthrough rate will be calculated as the number of clickthroughs divided by number of links sent (i.e., opportunities for clickthrough).
|
Every 3 months up to 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of dashboard visits
Time Frame: 15 months
|
Dashboard visits captured by Google Analytics.
|
15 months
|
|
Cumulative time (minutes) spent on the dashboard
Time Frame: 15 months
|
Time spent will be captured by Google Analytics.
|
15 months
|
|
Urologist opt-out rate
Time Frame: 15 months
|
15 months
|
|
|
Helpful/not helpful rate
Time Frame: 15 months
|
There will be one question if the intervention was helpful or not.
|
15 months
|
|
Stent rate for pre-stented ureteroscopy
Time Frame: 15 months
|
15 months
|
|
|
E-mail open rate
Time Frame: Every 3 months up to 15 months
|
E-mail open rate will be measured as number of e-mail opens divided by number of e-mails sent.
|
Every 3 months up to 15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristian Stensland, MD, University of Michigan
Publications and helpful links
General Publications
- Lewicki P, Clark S, Shoemaker E, Wang B, Ross J, Daignault-Newton S, Carlozzi N, Martin-Schwarze A, Meurer W, Sales A, Ghani K, Dauw C, Stensland K. Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial. Contemp Clin Trials Commun. 2025 Sep 20;48:101548. doi: 10.1016/j.conctc.2025.101548. eCollection 2025 Dec.
- Lewicki P, Salka B, Daignault-Newton S, Ross J, Krumm A, Ghani KR, Dauw C, Landis-Lewis Z, Stensland KD; Michigan Urological Surgery Improvement Collaborative. Rapid cycle, randomised testing of precision feedback to improve engagement with a process measure dashboard amongst urologists: study protocol for a hybrid trial. BMJ Open. 2025 May 6;15(5):e092742. doi: 10.1136/bmjopen-2024-092742.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00248876
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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