Vital Sign Assessment for Healthy Subjects

Overseen By Rachel Ward, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Youngstown State University

Disqualifiers: Less than 5 years experience, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Brief Summary The goal of this observational study is to develop consensus-based criteria for when vital sign assessment (VSA) should be performed in outpatient physical therapy settings. The primary purpose is to identify clinical signs, symptoms, and other factors that inform decision-making for VSA to improve patient safety and guide treatment progression.

Main Questions:

1. Which clinical characteristics indicate that vital signs should be assessed during outpatient physical therapy?

2. Which clinical characteristics indicate that vital signs do not need to be assessed?

Study Design:

This study uses a three-round electronic Delphi (e-Delphi) process to achieve expert consensus.

Comparison:

Researchers will compare responses across rounds to determine agreement and stability of criteria for inclusion in a decision algorithm.

Participants:

Licensed physical therapists with ≥5 years of clinical experience in outpatient settings.

Procedures:

Participants will:

Complete three rounds of online surveys via Qualtrics. Round 1: Suggest signs, symptoms, and factors for assessing or not assessing vitals.

Round 2: Rank importance of these factors on a 5-point Likert scale and suggest additional items.

Round 3: Review aggregated results and finalize consensus on criteria.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have worked as a physical therapist in an outpatient setting for at least 5 years.

I am a licensed physical therapist.

I can read and write in English proficiently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Round 1

Participants suggest signs, symptoms, and factors influencing VSA decisions

3 weeks

Online survey

Round 2

Participants rank the importance of factors on a 5-point Likert scale and may propose additional items

3 weeks

Online survey

Round 3

Participants review aggregated results and finalize consensus on criteria

3 weeks

Online survey

Follow-up

Participants are monitored for consensus stability and agreement

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Physical Therapists in an Outpatient Setting Experimental Treatment 1 Intervention

Expert Panel Cohort: Participants will be licensed physical therapists who meet the following inclusion criteria: 1. Minimum of 5 years of clinical experience in an outpatient physical therapy setting. 2. Proficient in English (reading and writing). 3. Willing to provide informed consent and complete all survey rounds.

Who Is Running the Clinical Trial?

Youngstown State University

Lead Sponsor

Trials

27

Recruited

2,000+