Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
1 other identifier
observational
301,000
1 country
1
Brief Summary
This is a research study evaluating the implementation of a clinic workflow to encourage pre-visit laboratory testing, such as blood work. The purpose of this research is to understand provider and patient satisfaction with clinic workflows to support pre-visit laboratory tests (blood work) for annual physical and wellness visits. Providers and staff at participating sites will be approached to fill out an anonymous survey regarding experiences with implementation of the pre-visit laboratory testing workflow. Additional data from NorthShore's Enterprise Data Warehouse (EDW) will be collected to assess the pre-lab test rate before implementation, at 6 months, and 12 months, in addition to provider and staff time efficiencies and patient satisfaction as assessed by surveys.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedStudy Start
First participant enrolled
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedApril 1, 2024
March 1, 2024
2.2 years
January 6, 2023
March 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline pre-lab test rate
Count of pre-lab tests completed out of the total number of annual physical/wellness visits to participating providers to participating providers
3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Secondary Outcomes (4)
Change from baseline clinician time spent resulting labs
baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline provider satisfaction
baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline patient satisfaction
baseline, 1 year, and 2 year (i.e. annually at every wellness/ annual physical visit)
Change from baseline frequency of patient encounters post visit
3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Study Arms (1)
Practices Engaged for Pre-Visit Lab Clinic Workflow
Providers and patients/ at the designated practice sites
Interventions
1. Based on buy-in from the providers/staff one or both of the practices below will be introduced into the clinic workflow to order pre-visit labs. 1. All procedures are within the standard of care, only the order of operations is being changed. After sharing lab results with patient from the most recent routine physical, physician records labs for the next calendar year in EMR. 2. Prior to appointment, Medical Assistant (MA) will review notes and orders to setup pre-visit labs. 2. Patient contacted to complete labs prior to the scheduled routine physical. 3. Resulted labs are triaged based on urgency. 4. After Visit Summary used to communicate about labs and surveys.
Eligibility Criteria
4 NorthShore Medical Group Primary Care (Family Medicine/ Internal Medicine/ non-specialty) sites will be asked to implement the study workflow for all prospective patients (approximately 30,000 total) seen between 11/1/2022- 11/1/2024 at the designated offices.
You may qualify if:
- Aged 18 or older.
- Patients must have had an annual physical/ wellness visit within 30 days of completing the survey.
- Patient/ providers willing to complete the survey.
You may not qualify if:
- Participants younger than 18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
- American Medical Associationcollaborator
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Related Publications (2)
Sinsky CA, Sinsky TA, Rajcevich E. Putting Pre-Visit Planning Into Practice. Fam Pract Manag. 2015 Nov-Dec;22(6):34-8. No abstract available.
PMID: 26761083BACKGROUNDAmerican Medical Association. 10 steps to pre-visit planning that can produce big savings. Sept 4, 2015. https://www.ama-assn.org/practice-management/sustainability/10-steps-pre-visit-planning-can-producebig-savings
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadim Ilbawi, MD
Endeavor Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Assistant Professor
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 31, 2023
Study Start
February 8, 2023
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
April 1, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share