Back-on-Track Studying Early Quality Care

Musculoskeletal Diseases Clinical Trial

— on-Track  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02522923
• Other study ID #: 23131
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2015
• Last updated: October 10, 2017
• Start date: January 2019
• Est. completion date: January 2020

Study information

• Verified date: October 2017
• Source: Temple University
• Contact: Heidi A Ojha, D.P.T.
• Phone: 650-804-0350
• Email: hojha[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Temple University Employee Health	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function on the 10-item short form PROMIS global health measure		6 weeks
Secondary	Physical function on the Patient Specific Functional Scale		6 weeks
Secondary	Overall Improvement on the Global Rating of Change		6 weeks
Secondary	Patient Satisfaction on a Likert scale		6 weeks
Secondary	Acceptability of Symptom State on the PASS		6 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		6 weeks
Secondary	Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage		6 weeks
Secondary	Number of Limited or Light Duty Days to Measure Work Status		6 weeks
Secondary	Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization		6 months
Secondary	Presenteeism as Measured by Participation at Work on Likert Scale		6 weeks