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NCT Number: NCT07258030

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • Generate a comprehensive list of factors that indicate when vital signs should or should not be assessed.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

E-Delphi

Other

Description:

Round 1: Participants provide open-ended responses identifying signs, symptoms, and factors influencing decisions to assess or not assess vital signs.

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

Round 3: Participants review aggregated results and finalize consensus on criteria for inclusion in a decision algorithm.

Mode of Delivery: Online survey via Qualtrics. Duration: Each round will remain open for 3 weeks, with reminder emails sent during weeks 1 and 2.

Primary outcomes

  1. Consensus on Criteria for Vital Sign Assessment

    Time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).

    Determine which clinical signs, symptoms, and contextual factors should be included in a decision algorithm for vital sign assessment in outpatient physical therapy.

    Metric: Consensus defined as:

    Median ≥ 4 (agreement) or ≤ 2 (disagreement) Interquartile Range (IQR) ≤ 1 Percent Agreement ≥ 75% in Round 2 and ≥ 80% in Round 3

Secondary outcomes

  1. Level of Agreement Among Experts

    Time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).

    Measure overall agreement across all items and categories. Metric: Kendall's Coefficient of Concordance (W), where 0 = no agreement and 1 = perfect agreement (p ≤ 0.05 for significance).

  2. Stability of Responses Between Rounds

    Time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).

    Assess consistency of expert ratings between Round 2 and Round 3 Metric: Wilcoxon rank-sum test (p ≤ 0.05) and Intraclass Correlation Coefficient (ICC).

Study contacts

Contact information is provided by the study sponsor or research team.

Edmund Ickert, PhD

CONTACT

[email protected]

330-941-1326

Rachel Ward, PT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Youngstown State University

Other

Registry information

Official study title

Development of a Decision Algorithm for Vital Sign Assessment in the Outpatient Physical Therapy Setting: An e-Delphi Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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