跳至主要内容
临床试验/NCT07258030
NCT07258030招募中不适用

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

Youngstown State University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Consensus on Criteria for Vital Sign Assessment

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Consensus on Criteria for Vital Sign Assessment

时间窗: 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

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edmund Ickert

Primary Investigator

Youngstown State University

研究点 (1)

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