Back-on-Track Studying Early Quality Care

Temple University

Status: Unknown

Conditions: Musculoskeletal Diseases

Treatments: Other: Physical Therapist; Other: Primary Care Provider

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02522923

23131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Physical Therapist

Experimental group

Description:

Participants randomized to this arm will receive care from a physical therapist first.

Treatment:

Other: Physical Therapist

Primary Care Provider

Active Comparator group

Description:

Participants randomized to this arm will receive care from a primary care provider first.

Treatment:

Other: Primary Care Provider