Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03110211 |
| Other study ID # |
Pro00081069 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 14, 2017 |
| Est. completion date |
January 1, 2019 |
Study information
| Verified date |
July 2018 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose and Objective: To determine the effectiveness of a physical therapist first versus a
primary care physician first for patients entering a primary care setting with a
musculoskeletal complaint on the outcomes of costs/charges, utilization and healthcare
satisfaction.
Study activities and population group: This will be a randomized clinical trial enrolling
patients who are seeking care to the Duke Outpatient Clinic with a musculoskeletal complaint.
Patients, adults aged 18 years or greater, that agree to be part of the study will be
randomized to see a physical therapist first or primary care physician first. All aspects of
the evaluation and treatment by both providers will be standard care for musculoskeletal
conditions.
Data analysis and risk/safety issues: Descriptive data including means and standard
deviations and counts and proportions of baseline scores will be conducted. Differences in
total costs/charges, opioid prescriptions, emergency department visits will be calculated and
tested across groups. Participants may not personally be helped by taking part in this study.
Participants may experience improvements in pain, function, or other symptoms from physical
therapy program in this study. There is a minimal risk of loss of confidentiality. If a
patient chooses not to participate, there will be no effect on their medical treatment and
the study team will cease contact.
Description:
The purpose of this study is to conduct a randomized clinical trial to examine the
effectiveness an initial evaluation by a physical therapist compared to a primary care
provider for patients with a musculoskeletal (MSK) complaint entering a primary care setting.
Background & Significance: MSK Conditions in Primary Care are Prevalent: More than 50% of the
US population reported MSK conditions in 2011. The increase number of people over the age of
65 years will continue to increase the number of people with MSK conditions and increase
demands on the health care system. The US healthcare system is already facing numerous
challenges and care inefficiencies. Care for MSK conditions in primary care is an important
area for care redesign to reduce inefficiencies. About 85% of people with MSK conditions have
at least one visit with a primary care provider (PCP) and average six visits a year.
Although, clinical guidelines recommend physical therapy as front-line care for MSK
conditions, referrals to physical therapy for evaluation and management are disproportionate
to the number in need. Uptake of these clinical guidelines is slow; yet advanced imaging and
prescriptions for opioids for MSK pain is common. There was a 142% increase in the number of
prescription medications filled by people with MSK conditions from 2009-2011. Overuse of
opioids and advanced imaging and underuse of physical therapy can be deviated with novel care
models that include physical therapists (PT) as frontline providers to where downstream
healthcare utilization and costs are reduced and patients' needs are more directly met.
Coordinated care models can impact outcomes for prevalent conditions in primary care but data
on MSK conditions is lacking: The high prevalence of depression among patients seeking
primary care led to new models of integrated care. Co-location, for example, has proven
successful for PCP and mental-health services, where it has almost doubled the rate of
guideline based care, facilitating collaboration and referral due to proximity of specialized
services. The current standard for primary care and patient-centered medical homes (PCMH) is
for patients with MSK-related pain or complaints to be seen and evaluated by a PCP and then
be recommended for advanced diagnostic imaging, opioids, or referral to PT at an offsite
location (sometimes considered the medical neighborhood). Referral to an offsite location may
negatively impact care continuity, provider communication and collaboration, and result in
lower patient satisfaction from de-fragmented care and overuse of unnecessary services and
prescription medication. Our approach to integrated and co-located PT could significantly
decrease healthcare costs, improve patient satisfaction with care, decrease "no-show" PT
rates and decrease physician burnout (by improving collaboration and satisfaction). In turn,
changing mainstream MSK care.
Design & Procedures: This is a one-year randomized clinical trial of a novel health system
redesign to study the immediate effect of a physical therapist first versus a primary care
provider first for MSK conditions within a single primary care setting, the Duke Outpatient
Clinic (DOC), at Duke University.
Randomization: This study will have two levels of randomization. Our biostatistician will
generate the randomization schedule using a computerized random number generator with equal
allocation to both groups for both levels of randomization. The investigators will use
Redcap's Randomization Module to implement randomization scheme after consent to randomize
appointments via phone. The first level consists of randomization to a Physical Therapist or
Primary Care Physician as front line provider, both are considered standard of care
approaches. The research coordinator will coordinate all randomization who will be blinded to
the primary outcomes data collection. The second level of randomization will occur in the
Primary Care Physician arm of the study. In this arm, if the Primary Care Physician decides
physical therapy is medically necessary then the participant will be randomized to either be
evaluated by an onsite Physical Therapist or receive a referral to be evaluated by an offsite
Physical Therapist at a location of their choosing which is the current model of care at the
DOC. This second level of randomization is so that the investigators can determine if
physical therapy outcomes provided onsite are better when compared to offsite.
For participants that meet eligibility and following informed consent by the research
coordinator, measures about demographics and health status will be completed. Patients
assigned to the physical therapist first group will receive an evaluation by a licensed
physical therapist onsite at the Duke Outpatient Clinic and be provided with a treatment plan
of care for their MSK complaint(s). This evaluation and treatment plan of care will follow
standard care currently implemented in clinical practice. Patients may return to the DOC for
follow-up treatments if the physical therapist deems this treatment to be medically
necessary. Patients assigned to the primary care provider group will receive an initial
evaluation from a licensed primary care provider onsite. The evaluation by the primary care
provider will follow standard care for evaluating MSK complaints in primary care. During the
evaluation, the primary care provider may decide to refer to physical therapy or not for the
patients with a MSK complaint. If the primary care provider refers to physical therapy the
patient will be randomly assigned to either see the physical therapist onsite at the DOC or
be assigned a referral to an offsite physical therapy clinic of the patients choosing with
the assistance of the research coordinator. If the primary care provider decides that
physical therapy is not medically necessary, the patient will follow the usual plan of care
and treatment recommendations provided by their primary care provider. Following the visit,
with either the physical therapist or primary care provider, the research coordinator will
ask the patient to complete a short patient satisfaction survey about the initial visit. At
approximately 3-months later the research coordinator will contact all enrolled patients by
phone to collect health status questions and satisfaction with healthcare. Also, at 3-months
outcomes related to total and MSK costs/charges will be collected by Duke University Health
System Finance, outcomes of opioid prescriptions and emergency department visits during the
3-month period will be collected by electronic health record / administrative data (DEDUCE)
and appointments to physical therapy that were referred offsite will be collect by
administrative data from the Department of Physical Therapy / Occupational Therapy. The
investigators will also collect, by electronic health record, usual care measures of
functional status. The study will end following the 3-month follow-up phone call and outcomes
and data are collected.
Study Interventions: All aspects related to physical therapy care are based on standard care
provided by physical therapists for MSK complaints. Current practice at the Duke Outpatient
Clinic consists of an onsite physical therapist to provide examinations, onsite exercise and
home based exercise programs, and pain control education. Our planned study will consist of
two interventions, both of which are standard care, however the investigators are modifying
the order of when a patient may be seen by a physical therapist for a MSK complaint within
the primary care setting. Our two interventions are physical therapist first or primary care
provider first. The primary care provider first model may utilize the onsite physical
therapist to provide physical therapy care by referral, known as the co-located primary care
provider to physical therapist model, or utilize physical therapy by offsite referral.
Physical Therapist First. This model builds upon our current clinical model of a physical
therapist co-located within the Duke Outpatient Clinic. This physical therapist has their own
assigned treatment room, are known to the front desk scheduling staff for scheduling
follow-up appointments, attend staff meetings and events and are considered a provider within
the DOC system. Full support for their co-location is provided by the administration of the
DOC and the Department of Physical and Occupational Therapy. The utilization of physical
therapy services is considered standard care; however, the timing of services is unique given
their co-location. This allows prompt access to not only physical therapy evaluation (billing
for services occurs) but consultation with primary care provider (contact note for
consultation in patients' medical records). For the current study, the investigators will
utilize this already co-located physical therapist to be a front-line provider for
musculoskeletal complaints of patients seeking care at the DOC. The physical therapist
evaluation will be standard care for all patients seeking care to a physical therapist. It
will not be modified in any way for the purposes of the study. If, at any time during
evaluation the physical therapist determines that the patient would benefit from an
additional primary care provider assessment, the patient will be scheduled for a primary care
provider assessment, which may happen immediately following the physical therapist
evaluation. In our experience these referrals from the physical therapist to primary care
provider can occur within the same day, which adds considerable value to the efficiency of
the integrated physical therapy model for those patients in need of additional primary care
provider assessment.
Primary Care Provider First. In this model, patients would have an initial assessment from
the primary care provider, which is considered standard care. If the primary care provider
deems that the patient should be referred for physical therapy for medically necessary
treatment, the research coordinator will randomly assign physical therapy referral to the
onsite physical therapist at the Duke Outpatient Clinic or to an offsite location. The
research coordinator will assist with scheduling and track referrals and all outcome data for
patients referred offsite. In some cases, the primary care provider will not refer to
physical therapy. In this case, the patients will follow the care recommendations provided by
the primary care provider.
Data Analysis & Statistical Considerations: The investigators will calculate differences in
total and MSK specific costs and charges between the physical therapist first group and the
primary care provider group using standard T-tests or tests of medians depending on the
distribution of data (parametric vs. non-parametric). The investigators will also calculate
differences in the number of opioid prescriptions and emergency department visits between the
two groups using chi-square categorical data analysis. The investigators will calculate
changes in already routinely collected disease specific measures stored in electronic health
record. Physical therapy missed appointments, patient and provider satisfaction will be
reported as descriptive data. The investigators will also explore differences in outcomes of
cost/charges, opioid prescriptions, emergency department visits and missed appointments
between onsite provided physical therapy to offsite physical therapy.
