Back-on-Track Studying Early Quality Care (on-Track)
Primary Purpose
Musculoskeletal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapist
Primary Care Provider
Sponsored by
About this trial
This is an interventional health services research trial for Musculoskeletal Diseases focused on measuring Physical Therapy Modalities, Primary Care, Health Services Research
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Temple University Employee Health
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical Therapist
Primary Care Provider
Arm Description
Participants randomized to this arm will receive care from a physical therapist first.
Participants randomized to this arm will receive care from a primary care provider first.
Outcomes
Primary Outcome Measures
Physical function on the 10-item short form PROMIS global health measure
Secondary Outcome Measures
Physical function on the Patient Specific Functional Scale
Overall Improvement on the Global Rating of Change
Patient Satisfaction on a Likert scale
Acceptability of Symptom State on the PASS
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage
Number of Limited or Light Duty Days to Measure Work Status
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization
Presenteeism as Measured by Participation at Work on Likert Scale
Full Information
NCT ID
NCT02522923
First Posted
July 29, 2015
Last Updated
October 10, 2017
Sponsor
Temple University
Collaborators
Brooke Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02522923
Brief Title
Back-on-Track Studying Early Quality Care
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Brooke Army Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Physical Therapy Modalities, Primary Care, Health Services Research
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapist
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive care from a physical therapist first.
Arm Title
Primary Care Provider
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive care from a primary care provider first.
Intervention Type
Other
Intervention Name(s)
Physical Therapist
Intervention Description
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
Intervention Name(s)
Primary Care Provider
Intervention Description
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 Outcome Measure Information:
Title
Physical function on the 10-item short form PROMIS global health measure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Physical function on the Patient Specific Functional Scale
Time Frame
6 weeks
Title
Overall Improvement on the Global Rating of Change
Time Frame
6 weeks
Title
Patient Satisfaction on a Likert scale
Time Frame
6 weeks
Title
Acceptability of Symptom State on the PASS
Time Frame
6 weeks
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
6 weeks
Title
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage
Time Frame
6 weeks
Title
Number of Limited or Light Duty Days to Measure Work Status
Time Frame
6 weeks
Title
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization
Time Frame
6 months
Title
Presenteeism as Measured by Participation at Work on Likert Scale
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi A Ojha, D.P.T.
Phone
650-804-0350
Email
hojha@temple.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi A Ojha, D.P.T.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Employee Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi A Ojha, DPT
Phone
650-804-0350
Email
hojha@temple.edu
First Name & Middle Initial & Last Name & Degree
Mark Denys, MHA, BS, RN
Phone
215-204-7391
Email
Mark.Denys@tuhs.temple.edu
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rhon
Phone
210-916-6100
Email
daniel.i.rhon.mil@mail.mil
12. IPD Sharing Statement
Citations:
PubMed Identifier
16294989
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.
Results Reference
result
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Back-on-Track Studying Early Quality Care
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