Physical ExaminationNCT05707364
Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
An observational study of Physical Examination and Diagnostic Tests, Routine, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Examination, Diagnostic Tests, Routine, Burnout, Professional
- What is being tested?
- Pre-visit Lab Workflow
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 301,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participants younger than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
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.
Read the 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.
- Being tested
- Pre-visit Lab Workflow
- Keywords
- Feasibility
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-visit Lab WorkflowBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Practices Engaged for Pre-Visit Lab Clinic Workflow | Providers and patients/ at the designated practice sites Receives: Behavioral: Pre-visit Lab Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Time questions asked in provider questionnaire
Measured: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline provider satisfaction
Agreement metrics (1= Strongly disagree to 5= Strongly agreed) asked in provider questionnaire. Higher scores indicate a better outcome.
Measured: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline patient satisfaction
Agreement metrics (1= Strongly disagree to 5= Strongly agreed) asked in provider questionnaire. Higher scores indicate a better outcome.
Measured: baseline, 1 year, and 2 year (i.e. annually at every wellness/ annual physical visit)
Change from baseline frequency of patient encounters post visit
Enterprise Data Warehouse data pull
Measured: 3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start8 Feb 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Association
- Responsible party
- Principal investigator, Nadim Ilbawi, Endeavor Health
- Investigators
- Nadim Ilbawi, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707364
- Sponsor's protocol ID
- EH22-450
- Status last verified
- Mar 2024
- First submitted
- 6 Jan 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26761083American 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
- ClinicalTrials.gov ID
- NCT05707364
- Acronym / sponsor ID
- EH22-450
- Keywords
- Feasibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 301,000 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- American Medical Association
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Practices Engaged for Pre-Visit Lab Clinic Workflow | – | Behavioral: Pre-visit Lab WorkflowProviders and patients/ at the designated practice sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants younger than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-visit Lab Workflow1. 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. | Behavioural | Practices Engaged for Pre-Visit Lab Clinic Workflow |
Primary outcome
Change from baseline pre-lab test rate
Time frame: 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
4 secondary outcomes
Change from baseline clinician time spent resulting labs
Time frame: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline provider satisfaction
Time frame: baseline (prior to study implementation), at 6-months of implementation, and at 1-year of implementation
Change from baseline patient satisfaction
Time frame: baseline, 1 year, and 2 year (i.e. annually at every wellness/ annual physical visit)
Change from baseline frequency of patient encounters post visit
Time frame: 3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 26761083Sinsky CA, Sinsky TA, Rajcevich E. Putting Pre-Visit Planning Into Practice. Fam Pract Manag. 2015 Nov-Dec;22(6):34-8. No abstract available.
- BackgroundAmerican 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadim Ilbawi, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Examination and Diagnostic Tests, Routine, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pre-lab test rate (time frame: 3 months prior to study implementation and then ongoing to month 24 to calculate monthly proportions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.