Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals

Sponsor
NorthShore University HealthSystem (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05707364
Collaborator
American Medical Association (Other)
301,000
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pre-visit Lab Workflow

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
301000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
Anticipated Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Practices Engaged for Pre-Visit Lab Clinic Workflow

Providers and patients/ at the designated practice sites

Behavioral: Pre-visit Lab Workflow
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. 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. Prior to appointment, Medical Assistant (MA) will review notes and orders to setup pre-visit labs. Patient contacted to complete labs prior to the scheduled routine physical. Resulted labs are triaged based on urgency. After Visit Summary used to communicate about labs and surveys.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline pre-lab test rate [3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions]

    Count of pre-lab tests completed out of the total number of annual physical/wellness visits to participating providers to participating providers

Secondary Outcome Measures

  1. Change from baseline clinician time spent resulting labs [baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation]

    Time questions asked in provider questionnaire

  2. Change from baseline provider satisfaction [baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation]

    Agreement metrics (1= Strongly disagree to 5= Strongly agreed) asked in provider questionnaire. Higher scores indicate a better outcome.

  3. Change from baseline patient satisfaction [baseline, 1 year, and 2 year (i.e. annually at every wellness/ annual physical visit)]

    Agreement metrics (1= Strongly disagree to 5= Strongly agreed) asked in provider questionnaire. Higher scores indicate a better outcome.

  4. 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]

    Enterprise Data Warehouse data pull

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NorthShore University HealthSystem
  • American Medical Association

Investigators

  • Principal Investigator: Nadim Ilbawi, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nadim Ilbawi, Principal Investigator, Clinical Assistant Professor, NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT05707364
Other Study ID Numbers:
  • EH22-450
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nadim Ilbawi, Principal Investigator, Clinical Assistant Professor, NorthShore University HealthSystem
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023