- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726802
Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury
November 27, 2017 updated by: Kathryn M. O'Bright (Finn), Reynolds Army Community Hospital
Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury: A Randomized Controlled Trial
This study aims to compare the self-report functional outcome measures, medical readiness and healthcare utilization (overall cost of imaging, prescription medications for pain, and follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical therapist versus primary care provider.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
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Fort Sill, Oklahoma, United States, 73053
- Reynolds Army Community Hospitral
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults over age 18
- Musculoskeletal injury or complaint < 3 months since onset
- Active duty service member, reachable by phone/e-mail within 3 months of initial encounter
Exclusion Criteria:
- Subject currently has a permanent profile for any reason OR subject has a temporary profile for a body part in the same half of the body as the current complaint OR solider is pending physical examination board (PEB) or undergoing/pending medical examination board (MEB)
- Individuals undergoing PEB/MEB are made aware that the end-state of the process includes a certain percentage of government monetary compensation based on their physical or mental disability, i.e, higher disability equates to greater pay. Because of this, individuals may be motivated to demonstrate worse outcomes as it may result in a higher disability "rating". For this reason, these individuals will be excluded from the study.
- Subject has been treated previously for the same condition within the past 3 months
- Subject has history of surgery for the same body part within the past 24 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Therapy route of entry
The subject will see a physical therapist as their initial encounter into the healthcare system
|
Subjects with acute (< 3 months onset) will be randomized to see either a physical therapist or a primary care provider as their initial entry into the healthcare system
|
|
Active Comparator: Primary Care Provider rout of entry
The subject will see a primary care provider as their initial encounter into the healthcare system
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Subjects with acute (< 3 months onset) will be randomized to see either a physical therapist or a primary care provider as their initial entry into the healthcare system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient Specific Functional Scale
Time Frame: 3 months
|
3 months
|
|
PROMIS physical function scale
Time Frame: 3 months
|
3 months
|
|
Global Rating of Change (GROC)
Time Frame: 3 months
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3 months
|
|
Defense and Veterans Pain Rating Scale
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Report Medical Readiness Questionnaire
Time Frame: 3 months
|
This questionnaire consists of 6 questions that ask the patient to rate their ability to perform various soldier/deployment-related tasks.
This will provide way of measuring the soldier's perceived status of medical readiness before and after episodes of medical care.
|
3 months
|
|
Medical Profile Status
Time Frame: 3 months
|
The medical profile is the Army's assessment of a soldier's overall medical readiness, i.e.: deployability.
A profile for musculoskeletal injury can be temporary (T) or permanent (P) and deployable (2) or non-deployable (3).
The profile is used to limit the soldier's activities to accommodate their injury or complaint.
Evaluating the medical profile status in this study will serve as a way to measure the subjects' medical readiness.
|
3 months
|
|
Overall Healthcare Consumption
Time Frame: 12 months
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overall healthcare consumption as measured by the dollar-value of each medical encounter following the initial encounter
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12 months
|
|
Patient Satisfaction
Time Frame: 3 months
|
Likert Scale 0-10, how satisfied is the patient with the care they received.
|
3 months
|
|
Report of adverse events
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
January 11, 2016
First Submitted That Met QC Criteria
April 1, 2016
First Posted (Estimate)
April 4, 2016
Study Record Updates
Last Update Posted (Actual)
November 29, 2017
Last Update Submitted That Met QC Criteria
November 27, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 413803-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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