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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: E-Delphi

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Edmund Ickert, PhD; Phone Number: 330-941-1326; Email: ecickert@ysu.edu
• Study Contact Backup: Name: Rachel Ward, PT; Email: reward@student.ysu.edu

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44555
      • Recruiting
      • Youngstown State University
      • Contact: Edmund Ickert, PhD; Phone Number: 330-941-1326; Email: ecickert@ysu.edu
      • Contact: Rachel Ward, PT; Email: reward@student.ysu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population consists of licensed physical therapists who are considered experts in outpatient care. To qualify, participants must have at least five years of clinical experience in an outpatient physical therapy setting, and be proficient in English for reading and writing. All participants must provide informed consent and agree to complete three rounds of the e-Delphi survey process.

Recruitment will occur nationally through professional networks, including American Board of Physical Therapy Specialties (ABPTS) listservs, state physical therapy associations, licensure boards, and social media outreach. Snowball sampling will be used by encouraging participants to share the study invitation with other eligible colleagues. The target population represents experienced clinicians who can provide expert input on decision-making for vital sign assessment in outpatient physical therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: E-Delphi; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consensus on Criteria for Vital Sign Assessment	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	Approximately 9 weeks after initiation of Round 1 (end of Round 3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Agreement Among Experts	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).	Approximately 9 weeks after initiation of Round 1 (end of Round 3).
Stability of Responses Between Rounds	Assess consistency of expert ratings between Round 2 and Round 3 Metric: Wilcoxon rank-sum test (p ≤ 0.05) and Intraclass Correlation Coefficient (ICC).	Approximately 9 weeks after initiation of Round 1 (end of Round 3).

Collaborators and Investigators

• Sponsor: Youngstown State University

Publications and helpful links

General Publications

• Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.
• Albarrati AM PT, PhD. Outpatient physical therapy cardiovascular assessment: Physical therapist perspective and experience. Physiother Theory Pract. 2019 Sep;35(9):843-850. doi: 10.1080/09593985.2018.1458355. Epub 2018 Mar 29.
• Faletra A, Bellin G, Dunning J, Fernandez-de-Las-Penas C, Pellicciari L, Brindisino F, Galeno E, Rossettini G, Maselli F, Severin R, Mourad F. Assessing cardiovascular parameters and risk factors in physical therapy practice: findings from a cross-sectional national survey and implication for clinical practice. BMC Musculoskelet Disord. 2022 Aug 4;23(1):749. doi: 10.1186/s12891-022-05696-w.
• Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15.
• Shang Z. Use of Delphi in health sciences research: A narrative review. Medicine (Baltimore). 2023 Feb 17;102(7):e32829. doi: 10.1097/MD.0000000000032829.
• Severin R, Sabbahi A, Albarrati A, Phillips SA, Arena S. Blood Pressure Screening by Outpatient Physical Therapists: A Call to Action and Clinical Recommendations. Phys Ther. 2020;100:1008-1019. Phys Ther. 2021 Jul 1;101(7):pzaa122. doi: 10.1093/ptj/pzaa122. No abstract available.
• Niederberger M, Spranger J. Delphi Technique in Health Sciences: A Map. Front Public Health. 2020 Sep 22;8:457. doi: 10.3389/fpubh.2020.00457. eCollection 2020.
• Gallotti M, Campagnola B, Cocchieri A, Mourad F, Heick JD, Maselli F. Effectiveness and Consequences of Direct Access in Physiotherapy: A Systematic Review. J Clin Med. 2023 Sep 7;12(18):5832. doi: 10.3390/jcm12185832.
• Severin R, Wang E, Wielechowski A, Phillips SA. Outpatient Physical Therapist Attitudes Toward and Behaviors in Cardiovascular Disease Screening: A National Survey. Phys Ther. 2019 Jul 1;99(7):833-848. doi: 10.1093/ptj/pzz042.

Study record dates

Study Major Dates

• Study Start (Estimated): November 21, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: algorithm; assessment; delphi; vital sign
• Other Study ID Numbers: 2026-90

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No