Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-03 @ 1:39 AM
Study NCT ID:
NCT06465667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Engagement With a Process Measure Dashboard Through Precision Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095489', 'term': 'Dashboard Systems'}], 'ancestors': [{'id': 'D003628', 'term': 'Database Management Systems'}, {'id': 'D008331', 'term': 'Management Information Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is be a stepped wedge randomized controlled trial of precision feedback. One hundred urologists will be randomized into four groups, stratified by case volume. The trial will consist of four steps of three months each, at the beginning of which one group will cross over from control to intervention arm. This is preceded by a three-month pre-rollout period, comprising a total study length of 15 months. The duration of the trial was chosen based on a desire to deliver "rapid" results to inform the scale-up of the intervention, and to mirror the period of time over which a typical dashboard project may be conceived, designed, and delivered. Case volume may predict dashboard engagement, stenting practices, and privileged awareness of ongoing study efforts, and is therefore suitable for stratification.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clickthrough rate to the online dashboard', 'timeFrame': 'Every 3 months up to 15 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Total number of dashboard visits', 'timeFrame': '15 months', 'description': 'Dashboard visits captured by Google Analytics.'}, {'measure': 'Cumulative time (minutes) spent on the dashboard', 'timeFrame': '15 months', 'description': 'Time spent will be captured by Google Analytics.'}, {'measure': 'Urologist opt-out rate', 'timeFrame': '15 months'}, {'measure': 'Helpful/not helpful rate', 'timeFrame': '15 months', 'description': 'There will be one question if the intervention was helpful or not.'}, {'measure': 'Stent rate for pre-stented ureteroscopy', 'timeFrame': '15 months'}, {'measure': 'E-mail open rate', 'timeFrame': 'Every 3 months up to 15 months', 'description': 'E-mail open rate will be measured as number of e-mail opens divided by number of e-mails sent.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ureteral stent omission', 'Ureteral stent placement', 'Behavior change', 'Dashboard', 'Precision feedback'], 'conditions': ['Behavior']}, 'referencesModule': {'references': [{'pmid': '40335130', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The study seeks to assess the impact of e-mailing specific, targeted, practice-pattern based information ("precision feedback") on provider engagement with a dashboard for a quality process measure (showing stent omission after pre-stented ureteroscopy), compared with generic information ("one size fits most" feedback).', 'detailedDescription': '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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-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.\n\nExclusion Criteria:\n\n\\- 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.'}, 'identificationModule': {'nctId': 'NCT06465667', 'briefTitle': 'Improving Engagement With a Process Measure Dashboard Through Precision Feedback', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Improving Engagement With a Process Measure Dashboard Through Precision Feedback', 'orgStudyIdInfo': {'id': 'HUM00248876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 dashboard (3 months) then dashboard with Precision feedback (12 months)', 'description': 'Months 0-3 dashboard only, months 3-15 months dashboard with Precision feedback.', 'interventionNames': ['Behavioral: Dashboard', 'Behavioral: Precision Feedback Push']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 dashboard (6 months) then dashboard with Precision feedback (6 months)', 'description': 'Months 0-6 dashboard only, months 6-15 months dashboard with Precision feedback.', 'interventionNames': ['Behavioral: Dashboard', 'Behavioral: Precision Feedback Push']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 dashboard (9 months) then dashboard with Precision feedback (6 months)', 'description': 'Months 0-9 dashboard only, months 9-15 months dashboard with Precision feedback.', 'interventionNames': ['Behavioral: Dashboard', 'Behavioral: Precision Feedback Push']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 dashboard (12 months) then dashboard with Precision feedback (3 months)', 'description': 'Months 0-12 dashboard only, months 12-15 months dashboard with Precision feedback.', 'interventionNames': ['Behavioral: Dashboard', 'Behavioral: Precision Feedback Push']}], 'interventions': [{'name': 'Dashboard', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group 1 dashboard (3 months) then dashboard with Precision feedback (12 months)', 'Group 2 dashboard (6 months) then dashboard with Precision feedback (6 months)', 'Group 3 dashboard (9 months) then dashboard with Precision feedback (6 months)', 'Group 4 dashboard (12 months) then dashboard with Precision feedback (3 months)']}, {'name': 'Precision Feedback Push', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group 1 dashboard (3 months) then dashboard with Precision feedback (12 months)', 'Group 2 dashboard (6 months) then dashboard with Precision feedback (6 months)', 'Group 3 dashboard (9 months) then dashboard with Precision feedback (6 months)', 'Group 4 dashboard (12 months) then dashboard with Precision feedback (3 months)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Kristian Stensland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Urology', 'investigatorFullName': 'Kristian Stensland', 'investigatorAffiliation': 'University of Michigan'}}}}