Back-on-Track Studying Early Quality Care (on-Track)

Comparison of Two Different Initial Entry Portals of Care for Patients Seeking Care for Musculoskeletal Pain: A Multisite Randomized Controlled Trial

This study is a randomized controlled trial conducted at two clinical sites. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Target enrollment is 150 subjects.

Study Overview

• Status: Unknown
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Other: Physical Therapist; Other: Primary Care Provider

Detailed Description

Physical therapists have an important role as initial contact providers for individuals with musculoskeletal disorders. Health care expenditures are on the rise each year in the U.S. and a large proportion is due to musculoskeletal disorders. Despite the rise in spending, there has not been an improvement in outcomes for individuals with musculoskeletal disorders. Furthermore, increased medical spending and utilization could expose patients to iatrogenic harm. Comparative effectiveness studies of different portals of entry would help to determine the most effective pathways for individuals with musculoskeletal disorders to seek care. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Subjects will be enrolled from two sites (Temple University, Philadelphia, PA and Brooke Army Medical Center, San Antonio, TX). Patient self-reported outcomes measures will be collected at baseline and 6 weeks. At 6 months, healthcare utilization will be assessed. The investigators plan to enroll a target sample size of 75 subjects per site (150 total). Descriptive statistics will be computed to characterize the 2 treatment groups with ANCOVA being used to assess differences between treatment groups at 6 weeks, adjusting for baseline values, evaluating the assumption of parallel slopes. The investigators will further investigate sources of systematic differences in response to treatment using methods such as generalized estimating equations and linear mixed effects models. This research will be the first multi-site study to compare effectiveness of these two pathways for individuals with musculoskeletal pain in the U.S. With a growing older adult population, the percentage of individuals who have musculoskeletal pain in the U.S. will only increase over time. This research study is timely and could meet the need for identifying the most effective pathway for individuals with musculoskeletal pain to seek care.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University Employee Health
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A patient at Temple University Employee Health, OR, Brooke Army Medical Center.
2. Able to speak English sufficiently to understand informed consent
3. A patient with a musculoskeletal condition as their primary complaint
4. Greater than 18 years old
5. Within 90 days (3 months) of either initial musculoskeletal onset or repeat acute recurrence of a previous episode

Exclusion Criteria:

1. Patients have already sought care from provider for their presenting condition for this current episode
2. Patients have an insurance plan that requires them to see an outside provider prior to seeing the study providers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Therapist; Participants randomized to this arm will receive care from a physical therapist first.	Other: Physical Therapist; The participant will receive an evaluation and intervention from a physical therapist. The patient will be referred onward to other providers as needed.
Active Comparator: Primary Care Provider; Participants randomized to this arm will receive care from a primary care provider first.	Other: Primary Care Provider; The participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical function on the 10-item short form PROMIS global health measure	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 weeks
Physical function on the Patient Specific Functional Scale	6 weeks
Overall Improvement on the Global Rating of Change	6 weeks
Patient Satisfaction on a Likert scale	6 weeks
Acceptability of Symptom State on the PASS	6 weeks
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage	6 weeks
Number of Limited or Light Duty Days to Measure Work Status	6 weeks
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization	6 months
Presenteeism as Measured by Participation at Work on Likert Scale	6 weeks

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Brooke Army Medical Center
• Investigators: Principal Investigator: Heidi A Ojha, D.P.T., Temple University

Publications and helpful links

General Publications

• Moore JH, McMillian DJ, Rosenthal MD, Weishaar MD. Risk determination for patients with direct access to physical therapy in military health care facilities. J Orthop Sports Phys Ther. 2005 Oct;35(10):674-8. doi: 10.2519/jospt.2005.35.10.674.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Primary Care; Health Services Research; Physical Therapy Modalities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 23131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No