Clinical trial NCT05707364: Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
Official title: Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Physical Examination
Diagnostic Tests, Routine
Burnout, Professional
Keywords: Feasibility
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: American Medical Association
First posted: 2023-01-31
Enrollment: 301000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: This is a research study about implementing a clinic workflow to encourage pre-visit laboratory testing, such as blood work. Resulting labs is a critical yet time consuming task for primary care clinicians. Ideal and timely management of both normal and abnormal lab results is best done when the patient and clinician are face to face in an office visit. This allows patients to ask questions and clinicians to most efficiently make recommendations, adjust or start medications, or order follow up testing. There is a notable and measurable time commitment to the in-basket burden of sharing lab results via a patient portal or phone calls, advising or counseling on these results and answering subsequent patient inquiries. Furthermore, in a consumer-centric health system and one in which routine blood tests are ordered for employment/insurance purposes and peace of mind, over-ordering of lab testing and the subsequent associated anxiety of out of range results are both costly to the patient and the health care system. Going "upstream" of the in-basket work associated with lab results requires a workflow that maximizes staff time, emphasizes patient engagement and understanding and most efficiently uses clinician time to guide good patient care.

The aims of this research study include to measure the feasibility of implementing a pre-visit lab testing clinic workflow, which involves clinicians using the electronic medical record (EMR) to indicate preferences that upcoming labs be completed prior to their scheduled physical so that results can be discussed during the office visit, and to study the efficacy of a pre-visit lab workflow as it relates to clinician in-basket time, staff time, patient satisfaction, provider satisfaction, and frequency of patient encounters post visit.

The study has multiple components to test these aims. Approximately 4 sites will be engaged to implement the study workflow for all prospective patients seen at the designated offices. Site physicians and their clinic staff will be invited to attend a Lunch \& Learn to discuss the intent to implement pre-visit lab testing and confirm the details of the clinic workflow. Data will be reviewed for progress reports and modifications to the clinical workflow can be made at that time to adjust for implementation barriers.

Longitudinal data from a brief survey will be collected from clinical staff (e.g. providers, practice managers, nurses, medical assistants, etc.) at three time points: prior to study implementation, at 6-months of implementation, and at 1-year of implementation. Practices will act as their own controls with their patients with labs resulted on/post-visit compared to those resulted pre-visit. Data sources will include EDW data, Press-Ganey scores, and physician surveys to assess time burden and satisfaction with workflow.

A secondary study component will involve anonymous patient surveys collected at every annual physical or wellness visit for the duration of the study. Additionally, patient data will be collected from existing sources (EPIC/Clarity, Press-Ganey, Enterprise Data Warehouse, billing, etc.) to assess the effectiveness of the workflow as it relates to patient understanding of their care.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• Participants younger than 18 years of age.

Primary outcomes:
measure: Change from baseline pre-lab test rate
timeFrame: 3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Secondary outcomes:
measure: Change from baseline clinician time spent resulting labs
timeFrame: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
measure: Change from baseline provider satisfaction
timeFrame: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
measure: Change from baseline patient satisfaction
timeFrame: baseline, 1 year, and 2 year (i.e. annually at every wellness/ annual physical visit)
measure: Change from baseline frequency of patient encounters post visit
timeFrame: 3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Nadim Ilbawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: American 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