Decision Algorithm for Vital Sign Assessment in the Outpatient Physical Therapy Setting

Youngstown State University

Status: Enrolling

Conditions: Healthy

Treatments: Other: E-Delphi

Study type: Observational

Funder types: Other

Identifiers

NCT07258030

2026-90

Details and patient eligibility

About

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.

Full description

Vital sign assessment (VSA) in outpatient physical therapy settings is underutilized despite its potential to improve patient safety and guide clinical decision-making. Physical therapists often rely on subjective patient reports rather than objective measures such as blood pressure, heart rate, and oxygen saturation. Evidence suggests that VSA can identify cardiovascular complications, detect early signs of physiological distress, and inform exercise intensity adjustments during treatment sessions. In the post-COVID-19 era, where direct access to physical therapy is common, integrating VSA into routine practice may help identify conditions such as postural orthostatic tachycardia syndrome, hypertension, and exertional desaturation that could otherwise go unnoticed.

Currently, there are no standardized criteria to guide outpatient physical therapists on when VSA is necessary. This study aims to fill that gap by developing a decision algorithm based on expert consensus. Using a three-round electronic Delphi (e-Delphi) process, the study will engage experienced outpatient physical therapists to identify and prioritize clinical signs, symptoms, and contextual factors that should influence VSA decisions.

Study Objectives:

1. Generate a comprehensive list of factors that indicate when vital signs should or should not be assessed.
2. Achieve expert consensus on which factors should be included in a decision-making algorithm for VSA.

Methods:

Participants will be licensed physical therapists with at least five years of outpatient clinical experience. Recruitment will occur nationally through professional networks, state associations, and social media. The e-Delphi process will be conducted via Qualtrics and will include three rounds:

Round 1: Participants suggest signs, symptoms, and factors influencing VSA decisions.

Round 2: Participants rank the importance of these factors on a 5-point Likert scale and may propose additional items.

Round 3: Participants review aggregated results and finalize consensus on criteria.

Consensus will be evaluated using descriptive and inferential statistics, including median, interquartile range, percent agreement, Kendall's coefficient of concordance, and stability measures across rounds. Statements achieving consensus will form the basis of a decision algorithm for VSA in outpatient physical therapy.

Significance:

This study will provide evidence-based guidance for outpatient physical therapists, promoting safer and more effective care by standardizing VSA practices. The resulting algorithm may improve early detection of physiological abnormalities, optimize treatment progression, and enhance patient outcomes.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Licensed physical therapist.
2. Minimum of 5 years of clinical experience in an outpatient physical therapy setting.
3. Proficient in English (reading and writing).
4. Ability to provide informed consent.

Exclusion criteria

1. Less than 5 years of outpatient physical therapy experience.
2. Inability to read or write in English.
3. Declines informed consent or does not agree to participate in all survey rounds

Trial design

100 participants in 1 patient group

Physical Therapists in an Outpatient Setting

Description:

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.

Treatment:

Other: E-Delphi