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

March 25, 2026 updated by: Brittany Lapin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction and Aims Most patients prefer to discharge from the hospital to their own home, but 11% of all hospitalized patients-and 22.4% of patients with Medicare-require discharge to a post-acute care facility. Hospital systems are increasingly incentivized to facilitate discharge home since a post-acute care facility stay is costly. Post-acute care is most often necessitated by a patient's functional decline during hospitalization. Physical therapists, whose primary treatment objective is generally to improve functional independence, could therefore play a crucial role in promoting improvements in functional status sufficient to enable a greater number of discharges to home.

In current practice, however, physical therapists in acute care hospitals do not generally address patients' function-related deficits. They do not generally have the opportunity to do so, since the Inpatient Prospective Payment System incentivizes short hospital stays. Nor have they needed to, since post-acute care facilities have become the primary setting for patients to regain functional independence. In this environment, physical therapists-a constrained resource in most hospitals primarily play a consultative role in which they evaluate functional status during a single visit in order to provide a recommendation for appropriate post-acute rehabilitation needs. With greater focus on ensuring value across the care continuum, healthcare systems are now striving to maintain short hospital stays, but also limit post-acute care utilization. This will require patients to achieve greater functional independence as quickly as possible within their hospital stay. Thus, the role of physical therapists in acute care hospitals must evolve.

Intervention

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 development and implementation strategy for the PT-PENCIL and analyze its effect on improving the proportion of patients who discharge home.

The PT-PENCIL will include two solutions integrated into the electronic health record (Epic). For both, Epic will use the underlying statistical model to identify patients for whom daily physical therapy may be indicated in order to facilitate a discharge to home. For such patients, an Epic best practice advisory (BPA) alert will appear on the screen, which will prompt therapists to consider a visit on the next day.

The second Epic-integrated solution is an indicator column on the patient lists maintained by therapists, which will identify patients who would benefit from daily PT (a green dot), those who would not (a red dot), and those for whom the PT-PENCIL did not run in Epic.

PT-PENCIL will be implemented into clinical care by means of a pilot hybrid type 2 design, informed by the PRISM (Practical, Robust Implementation and Sustainability Model) and RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) frameworks. We will accomplish the following primary specific aims:

Aim 1: Analyze the effect of using the PT-PENCIL on the proportion of patients discharged home.

Aim 2: Assess the reach, adoption, acceptability, appropriateness, and feasibility of the PT-PENCIL.

Study Type

Observational

Enrollment (Estimated)

9704

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion

- Individuals under the age of 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PT-PENCIL cohort
patients discharged from the hospital while the PT-PENCIL was active
Other: Electronic clinical decision support tool
Electronic clinical decision support tool
Control cohort
patients discharged from the hospital while the PT-PENCIL was not active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of evaluation on discharge home vs facility
Time Frame: Day of hospital discharge
Whether or not the patient was discharged home (vs. a facility)
Day of hospital discharge
Reach
Time Frame: Measured over the 24-week trial period
The number of patients for whom the PT-PENCIL algorithm ran in the EHR
Measured over the 24-week trial period
Adoption
Time Frame: Measured over the 24-week trial period
The number of therapists who acknowledge the PT-PENCIL best practice advisory
Measured over the 24-week trial period
Acceptability of PT-Pencil
Time Frame: Measured at baseline and conclusion of 24-week trial
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
Time Frame: Measured at baseline and conclusion of 24-week trial
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
Time Frame: Measured at baseline and conclusion of 24-week trial
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brittany Lapin

Collaborators

Learning Health Systems Rehabilitation Research Network

Investigators

  • Principal Investigator: Brittany Lapin, PhD, MPH, The Cleveland Clinic
  • Principal Investigator: Joshua Johnson, DPT, Cleveland Clinic Foundation/Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 23-626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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