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Temple University Employees With Musculoskeletal Conditions Receive Physical Therapy to Treat Limitations Early (TEMPLE)

Primary Purpose

Musculoskeletal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Direct Access Physical Therapy
Physician management
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Musculoskeletal Diseases focused on measuring Musculoskeletal Pain, Physical Therapists, Drug Prescriptions, Humans, Physical Therapy Modalities, Referral and Consultation, Workers' Compensation, United States, Primary Care, Health Services Research, Triage, Acute, Cost, Occupational Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Temple University Employees who speak English sufficiently to understand informed consent.
  • Has a primary complaint that is potentially of neuro-musculoskeletal origin. This is defined by a primary complaint of pain, numbness, or decreased function due to symptoms within regions of spine, shoulder, elbow, wrist/hand pain, pelvic/SI, hip, knee, or ankle pain, temporomandibular joint pain, or headaches. The complaint could be work related (workers compensation) or non-work related. This definition does not include abrasions, contusions, etc. that result in pain but do not affect the employee's function.
  • Age greater than or equal to 18 years old.
  • Employee's primary complaint began ≤3 months upon initial study screening. This could include a recent exacerbation (within ≤3 months onset) of a condition with a history of previous episodes. If the patient reports more than one complaint, all complaints will be addressed in the study with intervention that began within the ≤3 month timeframe.

Exclusion Criteria:

  • Met with another medical provider for advice for the condition prior to study enrollment (including physical therapist, chiropractor, physician, surgeon, physician-assistant, or nurse, etc.).
  • Medical history of surgery for a prior episode of complaint.
  • Any major psychiatric disease in their past medical history.
  • Red flags cannot be ruled out during the medical screening examination (e.g., cauda equina compression, inflammatory arthritis, malignancy, fracture, serious illness or comorbidity). Any musculoskeletal injuries that can be managed by a physical therapist will not be excluded (radiculopathy, potential ACL tear, peripheral nerve entrapments, etc.)

Sites / Locations

  • Temple University Employee Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Direct Access Physical Therapy

Physician management

Arm Description

All care will be administered by one or more physical therapists employed by Temple University. This arm will be early, direct access, physical therapy (immediately evaluation following contacting the front desk administrator or reporting a work injury). Intervention will include interventions matched to their stratified risk category incorporating biopsychosocially oriented education, therapeutic exercise, and manual therapy tailored to the patient's needs.

All usual care by physician will be administered by one or more employee health physicians employed by Temple University. Recommendations may or may not include referral to physical therapy.

Outcomes

Primary Outcome Measures

Total Episode Cost and codes billed affecting cost
Reimbursed amounts related to initial presenting condition of interest including physical therapy, diagnostics, and all medical interventions (Medication prescriptions, physical therapy visits, physician office visits, specialty visits, imaging ordered, injections performed, number of surgeries performed)

Secondary Outcome Measures

PROMIS, 10 item-Physical Function Questionnaire
Self report questionnaire to assess function, quality of life
Patient-Specific Functional Scale (PSFS)
Self report questionnaire (not region specific)
Pain Catastrophizing Score (PCS)
Self-report standardized questionnaire, Theorized mediator
Pain Self-efficacy questionnaire (PSEQ)
Self-report standardized questionnaire, Theorized mediator
Patient Satisfaction
Self report rating from 0-10
Patient Acceptable Symptom State (PASS)
Yes or No response to a written question if their current state is acceptable to patient.
Harm
complaints voiced to the Workers Compensation Director, adverse events reported in the chart (defined as an undesirable result of the PT evaluation, diagnosis, or prescribed intervention resulting in any short-term or permanent morbidity unexpected for patients with a like clinical presentation), and litigation claims filed.

Full Information

First Posted
October 20, 2014
Last Updated
October 10, 2017
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT02272257
Brief Title
Temple University Employees With Musculoskeletal Conditions Receive Physical Therapy to Treat Limitations Early
Acronym
TEMPLE
Official Title
Direct Access Physical Therapy Compared With Physician Portal of Entry for Temple University Employees With Recent Onset Musculoskeletal Conditions: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 7, 2015 (Actual)
Primary Completion Date
April 28, 2018 (Anticipated)
Study Completion Date
April 28, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether seeing a physical therapist first compared with seeing a physician first is more clinically and cost effective in an occupational setting for acute musculoskeletal conditions.
Detailed Description
Traditionally, when individuals sustain a musculoskeletal injury and require physical therapy intervention, a referral is obtained from a physician to prescribe therapy. Currently, for non-work related injuries, 48 out of the 50 United States are "direct access physical therapy states" meaning a consumer can be evaluated and treated by a physical therapist directly without physician referral. The number of direct access states is much less for work-related injuries, with only 17 of the 50 United States practice acts permitting direct access, and of these, most insurance companies still require a physician referral for reimbursement. A previous systematic review of the literature on this topic suggests that requiring a referral is associated with more drug prescriptions, more imaging ordered, and higher costs to the patient and health care system with no advantage in health outcomes. However, the cited studies were of low quality (i.e. below Level 1 evidence), so a high quality study with strict experimental controls is still necessary. This project proposes to conduct a blinded randomized controlled trial to determine if a "direct access physical therapy portal of entry" is more effective than a "physician portal of entry" in decreasing total episode cost and improving outcomes for individuals with a recent onset of musculoskeletal conditions. The project's definition of musculoskeletal pain is any "mechanical" spine or extremity pain from either a work condition (workers compensation) or a non-work related condition. The project investigators plan to recruit potential subjects directly from Temple University employees and supervisors. Subjects who consent to and pass a baseline screening will be randomized to one of two groups: direct access physical therapy management or Employee Health physician management. All PT and physician providers will be "study providers". Subjects randomized to direct access physical therapy will be evaluated and treated by a physical therapist. If the presentation requires further work up, the therapist will refer the patient for imaging or specialty consult. Subjects randomized to the Employee Health physician will receive a similar evaluation ordering relevant work up, and if appropriate, the physician will refer the patient to a physical therapist. Health outcomes for the two groups will be compared with a mixed-model repeated measures analysis at 1 month after enrollment. Total episode cost and medical utilization will be compared at one year after enrollment. If this direct access "Temple University model" is feasible and effective for managing compensated and non-compensated musculoskeletal conditions, it could serve as a paradigm for other universities to implement across the United States. Furthermore, this study would be the first data set in the literature that studied a physical therapy direct access model for evaluation and treatment of employees with "workers-compensation" conditions in the United States.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Musculoskeletal Pain, Physical Therapists, Drug Prescriptions, Humans, Physical Therapy Modalities, Referral and Consultation, Workers' Compensation, United States, Primary Care, Health Services Research, Triage, Acute, Cost, Occupational Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Direct Access Physical Therapy
Arm Type
Experimental
Arm Description
All care will be administered by one or more physical therapists employed by Temple University. This arm will be early, direct access, physical therapy (immediately evaluation following contacting the front desk administrator or reporting a work injury). Intervention will include interventions matched to their stratified risk category incorporating biopsychosocially oriented education, therapeutic exercise, and manual therapy tailored to the patient's needs.
Arm Title
Physician management
Arm Type
Active Comparator
Arm Description
All usual care by physician will be administered by one or more employee health physicians employed by Temple University. Recommendations may or may not include referral to physical therapy.
Intervention Type
Behavioral
Intervention Name(s)
Early Direct Access Physical Therapy
Other Intervention Name(s)
Physiotherapy management
Intervention Description
Physical Therapy management including Manual therapy, Exercise, and education including cognitive behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Physician management
Intervention Description
Physician management including advice, medication, and referral to physical therapy or other provider.
Primary Outcome Measure Information:
Title
Total Episode Cost and codes billed affecting cost
Description
Reimbursed amounts related to initial presenting condition of interest including physical therapy, diagnostics, and all medical interventions (Medication prescriptions, physical therapy visits, physician office visits, specialty visits, imaging ordered, injections performed, number of surgeries performed)
Time Frame
1 year post study enrollment
Secondary Outcome Measure Information:
Title
PROMIS, 10 item-Physical Function Questionnaire
Description
Self report questionnaire to assess function, quality of life
Time Frame
1 month post enrollement
Title
Patient-Specific Functional Scale (PSFS)
Description
Self report questionnaire (not region specific)
Time Frame
1 month post enrollment
Title
Pain Catastrophizing Score (PCS)
Description
Self-report standardized questionnaire, Theorized mediator
Time Frame
1 month post enrollment
Title
Pain Self-efficacy questionnaire (PSEQ)
Description
Self-report standardized questionnaire, Theorized mediator
Time Frame
1 month post enrollment
Title
Patient Satisfaction
Description
Self report rating from 0-10
Time Frame
1 month post enrollment
Title
Patient Acceptable Symptom State (PASS)
Description
Yes or No response to a written question if their current state is acceptable to patient.
Time Frame
1 month post enrollment
Title
Harm
Description
complaints voiced to the Workers Compensation Director, adverse events reported in the chart (defined as an undesirable result of the PT evaluation, diagnosis, or prescribed intervention resulting in any short-term or permanent morbidity unexpected for patients with a like clinical presentation), and litigation claims filed.
Time Frame
1 month post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Temple University Employees who speak English sufficiently to understand informed consent. Has a primary complaint that is potentially of neuro-musculoskeletal origin. This is defined by a primary complaint of pain, numbness, or decreased function due to symptoms within regions of spine, shoulder, elbow, wrist/hand pain, pelvic/SI, hip, knee, or ankle pain, temporomandibular joint pain, or headaches. The complaint could be work related (workers compensation) or non-work related. This definition does not include abrasions, contusions, etc. that result in pain but do not affect the employee's function. Age greater than or equal to 18 years old. Employee's primary complaint began ≤3 months upon initial study screening. This could include a recent exacerbation (within ≤3 months onset) of a condition with a history of previous episodes. If the patient reports more than one complaint, all complaints will be addressed in the study with intervention that began within the ≤3 month timeframe. Exclusion Criteria: Met with another medical provider for advice for the condition prior to study enrollment (including physical therapist, chiropractor, physician, surgeon, physician-assistant, or nurse, etc.). Medical history of surgery for a prior episode of complaint. Any major psychiatric disease in their past medical history. Red flags cannot be ruled out during the medical screening examination (e.g., cauda equina compression, inflammatory arthritis, malignancy, fracture, serious illness or comorbidity). Any musculoskeletal injuries that can be managed by a physical therapist will not be excluded (radiculopathy, potential ACL tear, peripheral nerve entrapments, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi A Ojha, DPT
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Employee Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22614792
Citation
Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.
Results Reference
result
PubMed Identifier
24029295
Citation
Ojha HA, Snyder RS, Davenport TE. Direct access compared with referred physical therapy episodes of care: a systematic review. Phys Ther. 2014 Jan;94(1):14-30. doi: 10.2522/ptj.20130096. Epub 2013 Sep 12.
Results Reference
result
PubMed Identifier
15507794
Citation
Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De Souza LH. Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2350-6. doi: 10.1097/01.brs.0000143619.34308.b4.
Results Reference
result
PubMed Identifier
10652686
Citation
Zigenfus GC, Yin J, Giang GM, Fogarty WT. Effectiveness of early physical therapy in the treatment of acute low back musculoskeletal disorders. J Occup Environ Med. 2000 Jan;42(1):35-9. doi: 10.1097/00043764-200001000-00010.
Results Reference
result
PubMed Identifier
32281269
Citation
Ojha HA, Fritz JM, Malitsky AL, Wu J, Weiner MG, Brandi JA, Rhon DI, Mobo BHP, Fleming KM, Beidleman RR, Wright WG. Comparison of Physical Therapy and Physician Pathways for Employees with Recent Onset Musculoskeletal Pain: A Randomized Controlled Trial. PM R. 2020 Nov;12(11):1071-1080. doi: 10.1002/pmrj.12382. Epub 2020 May 23.
Results Reference
derived
Links:
URL
http://www.directaccesssummit.com/studies/1.pdf
Description
Direct Access PT model in Nova Scotia for occupational soft tissue injuries

Learn more about this trial

Temple University Employees With Musculoskeletal Conditions Receive Physical Therapy to Treat Limitations Early

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