Temple University Employees With Musculoskeletal Conditions Receive Physical Therapy to Treat Limitations Early (TEMPLE)
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|ClinicalTrials.gov Identifier: NCT02272257|
Recruitment Status : Unknown
Verified April 2017 by Temple University.
Recruitment status was: Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Diseases||Behavioral: Early Direct Access Physical Therapy Behavioral: Physician management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|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.|
|Actual Study Start Date :||April 7, 2015|
|Estimated Primary Completion Date :||April 28, 2018|
|Estimated Study Completion Date :||April 28, 2018|
Experimental: Early Direct Access Physical Therapy
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.
Behavioral: Early Direct Access Physical Therapy
Physical Therapy management including Manual therapy, Exercise, and education including cognitive behavioral therapy.
Other Name: Physiotherapy management
Active Comparator: Physician management
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.
Behavioral: Physician management
Physician management including advice, medication, and referral to physical therapy or other provider.
- Total Episode Cost and codes billed affecting cost [ Time Frame: 1 year post study enrollment ]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)
- PROMIS, 10 item-Physical Function Questionnaire [ Time Frame: 1 month post enrollement ]Self report questionnaire to assess function, quality of life
- Patient-Specific Functional Scale (PSFS) [ Time Frame: 1 month post enrollment ]Self report questionnaire (not region specific)
- Pain Catastrophizing Score (PCS) [ Time Frame: 1 month post enrollment ]Self-report standardized questionnaire, Theorized mediator
- Pain Self-efficacy questionnaire (PSEQ) [ Time Frame: 1 month post enrollment ]Self-report standardized questionnaire, Theorized mediator
- Patient Satisfaction [ Time Frame: 1 month post enrollment ]Self report rating from 0-10
- Patient Acceptable Symptom State (PASS) [ Time Frame: 1 month post enrollment ]Yes or No response to a written question if their current state is acceptable to patient.
- Harm [ Time Frame: 1 month post enrollment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272257
|United States, Pennsylvania|
|Temple University Employee Health|
|Philadelphia, Pennsylvania, United States, 19122|
|Principal Investigator:||Heidi A Ojha, DPT||Temple University|