NCT02522923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3.4 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

July 29, 2015

Last Update Submit

October 10, 2017

Conditions

Musculoskeletal Diseases

Keywords

Physical Therapy ModalitiesPrimary CareHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • Physical function on the 10-item short form PROMIS global health measure

    6 weeks

Secondary Outcomes (9)

  • 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

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Physical Therapist

EXPERIMENTAL

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

Other: Physical Therapist

Primary Care Provider

ACTIVE COMPARATOR

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

Other: Primary Care Provider

Interventions

Physical TherapistOTHER

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

Physical Therapist
Primary Care ProviderOTHER

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

Primary Care Provider

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Temple University Employee Health

Philadelphia, Pennsylvania, 19122, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related 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. doi: 10.2519/jospt.2005.35.10.674.

    PMID: 16294989RESULT

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Physical TherapistsPhysicians, Primary Care

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and ServicesPhysicians

Study Officials

  • Heidi A Ojha, D.P.T.

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi A Ojha, D.P.T.

CONTACT

650-804-0350hojha@temple.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 13, 2015

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

US(2)