Decision Algorithm for Vital Sign Assessment in the Outpatient Physical Therapy Setting
ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYoungstown State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
E-Delphi
Other interventionDescription: 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Physical Therapists in an Outpatient Setting1 intervention
Trial outcomes
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
Time frame
Approximately 9 weeks after initiation of Round 1 (end of Round 3).Secondary outcomes
1
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).
Time frame
Approximately 9 weeks after initiation of Round 1 (end of Round 3).2
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).
Time frame
Approximately 9 weeks after initiation of Round 1 (end of Round 3).Sponsors and contacts
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Source ClinicalTrials.gov