Recruiting

Vital Sign Assessment

Sponsor:

Youngstown State University

Code:

NCT07258030

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

E-Delphi

Study Details

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. 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.

Conditions

Healthy

Study ID

NCT07258030

Start date

Nov 21, 2025

Status verified date

Nov, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Consensus on Criteria for Vital Sign Assessment [ Time Frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3). ]

Central Contacts and Locations

Central contacts

Locations

Youngstown State University

Recruiting

Youngstown, Ohio, United States, 44555

Contacts

More Information

Sponsor

Youngstown State University

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • delphi
  • vital sign
  • assessment
  • algorithm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Youngstown State University on 2025-12-02.