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Physical Therapy EvaluationPT-PENCIL ToolNCT05964205

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

An observational study of Physical Therapy Evaluation, run by Brittany Lapin at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Therapy Evaluation
What is being tested?
Electronic clinical decision support tool
How many people
9,704 participants
Where
1 siteUnited States
Study dates
18 Jul 2023to 1 Jan 2027
How long will I take part?
30 Days
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
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Individuals under the age of 18.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Read the 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.

Being tested
Electronic clinical decision support tool

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic clinical decision support toolOther

    Electronic clinical decision support tool

Study groups in NCT05964205
Study groupRoleWhat they receive
PT-PENCIL cohortpatients discharged from the hospital while the PT-PENCIL was active
Receives: Other: Electronic clinical decision support tool
Control cohortpatients discharged from the hospital while the PT-PENCIL was not active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of evaluation on discharge home vs facility

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

    Measured: Day of hospital discharge

  2. Reach

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

    Measured: Measured over the 24-week trial period

  3. Adoption

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

    Measured: Measured over the 24-week trial period

  4. 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: Measured at baseline and conclusion of 24-week trial

  5. 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: Measured at baseline and conclusion of 24-week trial

  6. 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: Measured at baseline and conclusion of 24-week trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start18 Jul 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jan 2027 (estimated)

Resources

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
Other
Enrolment
9,704 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964205
Sponsor's protocol ID
23-626
Acronym
PT-PENCIL Tool
Status last verified
Oct 2026
First submitted
18 Jul 2023
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ackerly DC, Grabowski DC. Post-acute care reform--beyond the ACA. N Engl J Med. 2014 Feb 20;370(8):689-91. doi: 10.1056/NEJMp1315350. No abstract available.

    PubMed 24552314
  • Robinson SM, Ni Bhuachalla B, Ni Mhaille B, Cotter PE, O'Connor M, O'Keeffe ST. Home, please: A conjoint analysis of patient preferences after a bad hip fracture. Geriatr Gerontol Int. 2015 Oct;15(10):1165-70. doi: 10.1111/ggi.12415. Epub 2014 Nov 19.

    PubMed 25407779
  • Augustine MR, Davenport C, Ornstein KA, Cuan M, Saenger P, Lubetsky S, Federman A, DeCherrie LV, Leff B, Siu AL. Implementation of Post-Acute Rehabilitation at Home: A Skilled Nursing Facility-Substitutive Model. J Am Geriatr Soc. 2020 Jul;68(7):1584-1593. doi: 10.1111/jgs.16474. Epub 2020 Apr 28.

    PubMed 32343401
  • McWilliams JM, Gilstrap LG, Stevenson DG, Chernew ME, Huskamp HA, Grabowski DC. Changes in Postacute Care in the Medicare Shared Savings Program. JAMA Intern Med. 2017 Apr 1;177(4):518-526. doi: 10.1001/jamainternmed.2016.9115.

    PubMed 28192556
  • Barnett ML, Mehrotra A, Grabowski DC. Postacute Care - The Piggy Bank for Savings in Alternative Payment Models? N Engl J Med. 2019 Jul 25;381(4):302-303. doi: 10.1056/NEJMp1901896. No abstract available.

    PubMed 31340092
  • Chandra A, Dalton MA, Holmes J. Large increases in spending on postacute care in Medicare point to the potential for cost savings in these settings. Health Aff (Millwood). 2013 May;32(5):864-72. doi: 10.1377/hlthaff.2012.1262.

    PubMed 23650319
  • Liu Z, Han L, Leo-Summers L, Gahbauer EA, Allore HG, Gill TM. The subsequent course of disability in older persons discharged to a skilled nursing facility after an acute hospitalization. Exp Gerontol. 2017 Oct 15;97:73-79. doi: 10.1016/j.exger.2017.08.004. Epub 2017 Aug 4.

    PubMed 28782593
  • Wald HL, Ramaswamy R, Perskin MH, Roberts L, Bogaisky M, Suen W, Mikhailovich A; Quality and Performance Measurement Committee of the American Geriatrics Society. The Case for Mobility Assessment in Hospitalized Older Adults: American Geriatrics Society White Paper Executive Summary. J Am Geriatr Soc. 2019 Jan;67(1):11-16. doi: 10.1111/jgs.15595. Epub 2018 Oct 1.

    PubMed 30276809
  • Robinson TN, Wallace JI, Wu DS, Wiktor A, Pointer LF, Pfister SM, Sharp TJ, Buckley MJ, Moss M. Accumulated frailty characteristics predict postoperative discharge institutionalization in the geriatric patient. J Am Coll Surg. 2011 Jul;213(1):37-42; discussion 42-4. doi: 10.1016/j.jamcollsurg.2011.01.056. Epub 2011 Mar 23.

    PubMed 21435921
  • Jenq GY, Tinetti ME. Post-acute care: who belongs where? JAMA Intern Med. 2015 Feb;175(2):296-7. doi: 10.1001/jamainternmed.2014.4298. No abstract available.

    PubMed 25437105
  • Chang FH, Ni P, Jette AM. Does activity limitation predict discharge destination for postacute care patients? Am J Phys Med Rehabil. 2014 Sep;93(9):782-90. doi: 10.1097/PHM.0000000000000097.

    PubMed 24800717
  • Hoyer EH, Young DL, Friedman LA, Brotman DJ, Klein LM, Friedman M, Needham DM. Routine Inpatient Mobility Assessment and Hospital Discharge Planning. JAMA Intern Med. 2019 Jan 1;179(1):118-120. doi: 10.1001/jamainternmed.2018.5145.

    PubMed 30476953
  • Gustavson AM, Toonstra A, Johnson JK, Ensrud KE. Reframing Hospital to Home Discharge from "Should We?" to "How Can We?": COVID-19 and Beyond. J Am Geriatr Soc. 2021 Mar;69(3):608-609. doi: 10.1111/jgs.17036. Epub 2021 Feb 6. No abstract available.

    PubMed 33470419
  • Young DL, Moonie S, Bungum T. Cross-Sectional Examination of Patient and Therapist Factors Affecting Participation in Physical Therapy in Acute Care Hospital Settings. Phys Ther. 2017 Jan 1;97(1):3-12. doi: 10.2522/ptj.20150591.

    PubMed 27340196
  • Johnson JK, Lapin B, Green K, Stilphen M. Frequency of Physical Therapist Intervention Is Associated With Mobility Status and Disposition at Hospital Discharge for Patients With COVID-19. Phys Ther. 2021 Jan 4;101(1):pzaa181. doi: 10.1093/ptj/pzaa181.

    PubMed 32986836

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Therapy Evaluation, run by Brittany Lapin 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of evaluation on discharge home vs facility (time frame: Day of hospital discharge). The study lists 6 primary outcomes in all. 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 NCT05964205, which also lists 39 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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