Physical Therapy Direct AccessNCT02726802
Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury
A study testing physical therapy vs. primary care interventions in people with Physical Therapy Direct Access and Physical Therapy Primary Care, run by Reynolds Army Community Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy Direct Access, Physical Therapy Primary Care
- What is being tested?
- physical therapy vs. primary care interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Reynolds Army Community Hospitral
Fort Sill, Oklahoma, 73053
About this study
Official title: 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.
- Being tested
- physical therapy vs. primary care interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy vs. primary care interventionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy route of entry | Experimental | The subject will see a physical therapist as their initial encounter into the healthcare system Receives: Other: physical therapy vs. primary care interventions |
| Primary Care Provider rout of entry | Active comparator | The subject will see a primary care provider as their initial encounter into the healthcare system Receives: Other: physical therapy vs. primary care interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Specific Functional Scale
Measured: 3 months
PROMIS physical function scale
Measured: 3 months
Global Rating of Change (GROC)
Measured: 3 months
Defense and Veterans Pain Rating Scale
Measured: 3 months
Secondary outcomes (5)
Self-Report Medical Readiness Questionnaire
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.
Measured: 3 months
Medical Profile Status
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.
Measured: 3 months
Overall Healthcare Consumption
overall healthcare consumption as measured by the dollar-value of each medical encounter following the initial encounter
Measured: 12 months
Patient Satisfaction
Likert Scale 0-10, how satisfied is the patient with the care they received.
Measured: 3 months
Report of adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Therapy Direct AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reynolds Army Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Brooke Army Medical Center, Temple University
- Responsible party
- Principal investigator, Kathryn M. O'Bright (Finn), Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726802
- Sponsor's protocol ID
- 413803-1
- Status last verified
- Nov 2017
- First submitted
- 11 Jan 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02726802
- Acronym / sponsor ID
- 413803-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Reynolds Army Community HospitalUS federal agency
- Collaborators
- Brooke Army Medical Center, Temple University
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy route of entry | Experimental | Other: physical therapy vs. primary care interventionsThe subject will see a physical therapist as their initial encounter into the healthcare system |
| Primary Care Provider rout of entry | Active comparator | Other: physical therapy vs. primary care interventionsThe subject will see a primary care provider as their initial encounter into the healthcare system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy vs. primary care interventionsSubjects 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 | Other | Physical Therapy route of entry, Primary Care Provider rout of entry |
Primary outcome
Patient Specific Functional Scale
Time frame: 3 months
PROMIS physical function scale
Time frame: 3 months
Global Rating of Change (GROC)
Time frame: 3 months
Defense and Veterans Pain Rating Scale
Time frame: 3 months
5 secondary outcomes
Self-Report Medical Readiness Questionnaire
Time frame: 3 months
Medical Profile Status
Time frame: 3 months
Overall Healthcare Consumption
Time frame: 12 months
Patient Satisfaction
Time frame: 3 months
Report of adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy vs. primary care interventions in people with Physical Therapy Direct Access and Physical Therapy Primary Care, run by Reynolds Army Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Specific Functional Scale (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.