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

NCT07258030 | Recruiting

• 1 other identifier: 2026-90
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Which clinical characteristics indicate that vital signs should be assessed during outpatient physical therapy?
2. 2.Which clinical characteristics indicate that vital signs do not need to be assessed?

Conditions

Healthy

Keywords

delphi; vital sign; assessment; algorithm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Level of Agreement Among Experts

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

• Stability of Responses Between Rounds

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

Study Arms (1)

Physical Therapists in an Outpatient Setting

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.

Other: E-Delphi

Interventions

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.

Physical Therapists in an Outpatient Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 36800594 BACKGROUND

• 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.

  PMID: 34279665 BACKGROUND

• 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.

  PMID: 33380887 BACKGROUND

• 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.

  PMID: 33072683 BACKGROUND

• 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.

  PMID: 34322364 BACKGROUND

• 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.

  PMID: 37762773 BACKGROUND

• 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.

  PMID: 35927658 BACKGROUND

• 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.

  PMID: 30883642 BACKGROUND

• 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.

  PMID: 29596007 BACKGROUND

Central Study Contacts

Edmund Ickert, PhD

CONTACT

330-941-1326; ecickert@ysu.edu

Rachel Ward, PT

CONTACT

reward@student.ysu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start: November 21, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)