NCT03110211

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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

March 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

March 31, 2017

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Total patient costs accrued for musculoskeletal care during the 3 month study period

    Total costs accrued for musculoskeletal care will be aggregated and abstracted by revenue code by the Duke University Health System Department of Finance

    3 months

  • Total patient charges submitted for musculoskeletal care during the 3 month study period

    Total charges submitted for musculoskeletal care will be aggregated and abstracted by revenue code by the Duke University Health System Department of Finance

    3 months

Secondary Outcomes (7)

  • Patient Satisfaction with Healthcare

    3 months

  • Opioid prescriptions

    3 months

  • Emergency Room Visits

    3 months

  • Imaging received

    3 months

  • Physical Therapy Missed Appointments

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Physical Therapist Evaluation

EXPERIMENTAL

Patients are randomized to have an initial appointment with a physical therapist for a musculoskeletal complaint. The intervention is an initial evaluation and treatment recommendations by a physical therapist.

Procedure: Physical Therapist Evaluation

Primary Care Physician Evaluation

EXPERIMENTAL

Patients are randomized to have an initial appointment with a primary care physician for a musculoskeletal complaint. The intervention is an initial evaluation and treatment recommendations by a primary care physician.

Procedure: Primary Care Physician

Interventions

Participants assigned to this group will receive an initial evaluation and treatment recommendations by a physical therapist.

Also known as: PT First
Physical Therapist Evaluation

Participants assigned to this group will receive an initial evaluation and treatment recommendations by a primary care physician.

Also known as: PCP First
Primary Care Physician Evaluation

Eligibility Criteria

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

You may qualify if:

  • Patients seeking care to the Duke Outpatient Clinic for a musculoskeletal complaint
  • Patients speak English

You may not qualify if:

  • Physical Therapist determines inappropriate for study due to medical reasons
  • Patient does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Outpatient Clinic

Durham, North Carolina, 27704, United States

Location

Related Publications (8)

  • Storheim K, Zwart JA. Musculoskeletal disorders and the Global Burden of Disease study. Ann Rheum Dis. 2014 Jun;73(6):949-50. doi: 10.1136/annrheumdis-2014-205327. No abstract available.

    PMID: 24790065BACKGROUND
  • Goode AP, Freburger JK, Carey TS. The influence of rural versus urban residence on utilization and receipt of care for chronic low back pain. J Rural Health. 2013 Spring;29(2):205-14. doi: 10.1111/j.1748-0361.2012.00436.x. Epub 2012 Sep 27.

    PMID: 23551651BACKGROUND
  • Carey TS, Freburger JK. Exercise and the Prevention of Low Back Pain: Ready for Implementation. JAMA Intern Med. 2016 Feb;176(2):208-9. doi: 10.1001/jamainternmed.2015.7636. No abstract available.

    PMID: 26752108BACKGROUND
  • Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.

    PMID: 19204216BACKGROUND
  • Carey TS, Freburger JK, Holmes GM, Castel L, Darter J, Agans R, Kalsbeek W, Jackman A. A long way to go: practice patterns and evidence in chronic low back pain care. Spine (Phila Pa 1976). 2009 Apr 1;34(7):718-24. doi: 10.1097/BRS.0b013e31819792b0.

    PMID: 19282797BACKGROUND
  • Katon W. Health reform, research pave way for collaborative care for mental illness. Interview by Bridge M. Kuehn. JAMA. 2013 Jun 19;309(23):2425-6. doi: 10.1001/jama.2013.6494. No abstract available.

    PMID: 23780435BACKGROUND
  • Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012 Aug;169(8):790-804. doi: 10.1176/appi.ajp.2012.11111616.

    PMID: 22772364BACKGROUND
  • Carvalho E, Bettger JP, Bowlby L, Carvalho M, Dore D, Corcoran MW, Harris AA, Bond J, Goode AP. Integration of musculoskeletal physical therapy care in the patient-centred medical home (IMPaC): protocol for a single-site randomised clinical trial. BMJ Open. 2018 Aug 8;8(8):e022953. doi: 10.1136/bmjopen-2018-022953.

MeSH Terms

Conditions

Collagen Diseases

Interventions

Physicians, Primary Care

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Adam P Goode, DPT, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 12, 2017

Study Start

August 14, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 15, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations