Back-on-Track Studying Early Quality Care

NCT ID: NCT02522923

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-01-31

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.

Conditions

Musculoskeletal Diseases

Keywords

Physical Therapy Modalities; Primary Care; Health Services Research

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Physical Therapist

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

Group Type: EXPERIMENTAL

Physical Therapist

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Primary Care Provider

Intervention Type: OTHER

The participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi A Ojha, D.P.T.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University Employee Health

Philadelphia, Pennsylvania, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Central Contacts

Heidi A Ojha, D.P.T.

Role: CONTACT

Phone: 650-804-0350

Email: hojha@temple.edu

Facility Contacts

Heidi A Ojha, DPT

Role: primary

Mark Denys, MHA, BS, RN

Role: backup

Daniel Rhon

Role: primary

References

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.

Reference Type: RESULT

PMID: 16294989 (View on PubMed)

Other Identifiers

23131

Identifier Type: -

Identifier Source: org_study_id