Analysis of a Stepped-Wedge Implementation of the PT-PENCIL Tool

NCT05964205 | Active Not Recruiting

• 1 other identifier: 23-626
• Study Type: observational
• Target: 9,704
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the need to evolve, the fact that physical therapists are a constrained resource prompts the need for care prioritization that is optimally targeted. It is currently unclear which patients need physical therapist intervention in the hospital, and how much physical therapy is necessary, in order to achieve a functional status that is adequate to discharge home. We have developed a patient-level clinical decision support tool to guide optimal treatment frequency. This tool-the Physical Therapy Frequency Clinical Decision Support Tool, or "PT-PENCIL"-is based on a statistical model that predicts discharge home relative to the frequency of physical therapist treatment. The primary goals of this study are to assess the implementation strategy for the PT-PENCIL and analyze its effect on improving the proportion of patients who discharge home.

Conditions

Physical Therapy Evaluation

Outcome Measures

Primary Outcomes (6)

• Effectiveness of evaluation on discharge home vs facility

  Whether or not the patient was discharged home (vs. a facility)

  Day of hospital discharge

• Reach

  The number of patients for whom the PT-PENCIL algorithm ran in the EHR

  Measured over the 24-week trial period

• Adoption

  The number of therapists who acknowledge the PT-PENCIL best practice advisory

  Measured over the 24-week trial period

• Acceptability of PT-Pencil

  The rating of acceptability amongst physical therapists completing the Acceptability of the Intervention Measure (AIM) higher scores indicates greater acceptability. The scale ranges from 1-5.

  Measured at baseline and conclusion of 24-week trial

• Appropriateness of PT-Pencil

  The rating of appropriateness amongst physical therapists completing the Intervention Appropriateness Measure (IAM) higher scores indicates greater appropriateness. The scale ranges from 1-5.

  Measured at baseline and conclusion of 24-week trial

• Feasibility Rate of PT-Pencil

  The rating of feasibility amongst physical therapists completing the Feasibility of the Intervention Measure (FIM) higher scores indicates greater feasibility. The scale ranges from 1-5.

  Measured at baseline and conclusion of 24-week trial

Study Arms (2)

PT-PENCIL cohort

patients discharged from the hospital while the PT-PENCIL was active

Other: Electronic clinical decision support tool

Control cohort

patients discharged from the hospital while the PT-PENCIL was not active

Interventions

Electronic clinical decision support tool OTHER

Electronic clinical decision support tool

PT-PENCIL cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Physical Therapists at CCF Main, Fairview, \& Hillcrest hospitals who are being trained on the use and implementation of the PT-PENCIL tool for general clinical care. Patients (SOC data) who are seen by physical therapists at CCF Main, Fairview, \& Hillcrest hospitals during the study time period, who may or may not (dependent on the pilot stepped-wedge design, see protocol) have the PT-PENCIL tool utilized in their care.

You may qualify if:

• Admitted for at least one overnight
• Total ICU LOS \< 48 hours
• Primary medical service is any of: cardiology, vascular medicine, cardiac surgery, thoracic surgery, vascular surgery, dermatology, endocrinology, hepatology, internal medicine, obstetrics/gynecology, pulmonology, nephrology, urology, colorectal surgery, general surgery, neurology, neurosurgery

You may not qualify if:

• \- Individuals under the age of 18.

Sponsors & Collaborators

• Brittany Lapin: lead
• Learning Health Systems Rehabilitation Research Network: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

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  BACKGROUND

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  BACKGROUND

Study Officials

• Brittany Lapin, PhD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Joshua Johnson, DPT

  Cleveland Clinic Foundation/Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: July 18, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)