Clinical trial NCT02522923: Back-on-Track Studying Early Quality Care
Official title: Comparison of Two Different Initial Entry Portals of Care for Patients Seeking Care for Musculoskeletal Pain: A Multisite Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Physical Therapy Modalities
Primary Care
Health Services Research
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
First posted: 2015-08-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical function on the 10-item short form PROMIS global health measure
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical function on the Patient Specific Functional Scale
timeFrame: 6 weeks
measure: Overall Improvement on the Global Rating of Change
timeFrame: 6 weeks
measure: Patient Satisfaction on a Likert scale
timeFrame: 6 weeks
measure: Acceptability of Symptom State on the PASS
timeFrame: 6 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 weeks
measure: Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage
timeFrame: 6 weeks
measure: Number of Limited or Light Duty Days to Measure Work Status
timeFrame: 6 weeks
measure: Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization
timeFrame: 6 months
measure: Presenteeism as Measured by Participation at Work on Likert Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Employee Health
state: Pennsylvania
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Temple University
name: Heidi A Ojha, D.P.T.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.