Clinical trial NCT05964205: Analysis of a Stepped-Wedge Implementation of the PT-PENCIL Tool
Official title: Analysis of a Stepped-Wedge Implementation of the PT-PENCIL Tool
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Physical Therapy Evaluation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Learning Health Systems Rehabilitation Research Network
First posted: 2023-07-27
Enrollment: 9704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of evaluation on discharge home vs facility
timeFrame: Day of hospital discharge
measure: Reach
timeFrame: Measured over the 24-week trial period
measure: Adoption
timeFrame: Measured over the 24-week trial period
measure: Acceptability of PT-Pencil
timeFrame: Measured at baseline and conclusion of 24-week trial
measure: Appropriateness of PT-Pencil
timeFrame: Measured at baseline and conclusion of 24-week trial
measure: Feasibility Rate of PT-Pencil
timeFrame: Measured at baseline and conclusion of 24-week trial
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Brittany Lapin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Foundation/Duke University
name: Joshua Johnson, DPT
role: PRINCIPAL_INVESTIGATOR
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