HealthyNCT07258030
Decision Algorithm for Vital Sign Assessment in the Outpatient Physical Therapy Setting
An observational study of Healthy, run by Youngstown State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- E-Delphi
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Ward, PT contact
United States1 site, 1 recruiting
- Recruiting
Youngstown State University
Youngstown, Ohio, 44555
Edmund Ickert, PhD, 330-941-1326, ecickert@ysu.edu
Rachel Ward, PT, reward@student.ysu.edu
About this study
Official title: 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:
Read more
- Which clinical characteristics indicate that vital signs should be assessed during outpatient physical therapy?
- 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.
Read the 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:
- Generate a comprehensive list of factors that indicate when vital signs should or should not be assessed.
- 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.
- Conditions
- Healthy
- Being tested
- E-Delphi
- Keywords
- delphi, vital sign, assessment, algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-DelphiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: E-Delphi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 9 weeks after initiation of Round 1 (end of Round 3).
Secondary outcomes (2)
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).
Measured: 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).
Measured: Approximately 9 weeks after initiation of Round 1 (end of Round 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start21 Nov 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmund Ickert, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258030
- Sponsor's protocol ID
- 2026-90
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36800594Severin 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.
PubMed 34279665Serdar 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.
PubMed 33380887Niederberger 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.
PubMed 33072683Nasa 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.
PubMed 34322364Gallotti 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.
PubMed 37762773Faletra 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.
PubMed 35927658Severin 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.
PubMed 30883642Albarrati 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.
PubMed 29596007
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision Algorithm for Vital Sign Assessment in the Outpatient Physical Therapy Setting: An e-Delphi Study
- ClinicalTrials.gov ID
- NCT07258030
- Acronym / sponsor ID
- 2026-90
- Conditions
- Healthy
- Keywords
- delphi, vital sign, assessment, algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 21 Nov 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which clinical characteristics indicate that vital signs should be assessed during outpatient physical therapy?
- 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.
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:
- Generate a comprehensive list of factors that indicate when vital signs should or should not be assessed.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Therapists in an Outpatient Setting | – | Other: E-DelphiExpert 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-DelphiDescription: 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. | Other | Physical Therapists in an Outpatient Setting |
Primary outcome
Consensus on Criteria for Vital Sign Assessment
Time frame: 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
2 secondary outcomes
Level of Agreement Among Experts
Time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).
Stability of Responses Between Rounds
Time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 36800594Shang Z. Use of Delphi in health sciences research: A narrative review. Medicine (Baltimore). 2023 Feb 17;102(7):e32829. doi: 10.1097/MD.0000000000032829.
- Background: PubMed 34279665Severin 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.
- Background: PubMed 33380887Serdar 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.
- Background: PubMed 33072683Niederberger 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.
- Background: PubMed 34322364Nasa 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.
- Background: PubMed 37762773Gallotti 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.
- Background: PubMed 35927658Faletra 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.
- Background: PubMed 30883642Severin 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.
- Background: PubMed 29596007Albarrati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Ward, PT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Youngstown State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edmund Ickert, PhD (330-941-1326, ecickert@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus on Criteria for Vital Sign Assessment (time frame: Approximately 9 weeks after initiation of Round 1 (end of Round 3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258030, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.