NCT05707364

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
301,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

January 6, 2023

Last Update Submit

March 29, 2024

Conditions

Keywords

Feasibility

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

Behavioral: Pre-visit Lab Workflow

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.

Practices Engaged for Pre-Visit Lab Clinic Workflow

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

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: 26761083BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Nadim Ilbawi, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

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

Locations