Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth

Study Overview
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Brief Summary
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The purpose of this project is to compare usual care for chronic low back disorders in a rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy (PT) into a rural health care team: in-person PT assessment, where the PT travels from an urban center interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth. The project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. The hypothesis is that an interprofessional Telehealth assessment with be as effective as an in-person PT assessment, but more effective than usual care.

Detailed Description
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The study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person PT and, 3. usual-care provided by a NP. Due to the interprofessional nature of the intervention, the NP involved in the telehealth-based intervention group may alter their usual care practice; therefore, the control group participants will be drawn from the practices of 2 NPs not involved in the Telehealth intervention providing services out of a different clinic. Each PT and the NP alone will complete a standardized online diagnostic classification tool.Participants will be randomly assigned to one of the three groups.

Official Title
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Advancing Interprofessional Primary Health Care Services in Rural Settings for People With Chronic Low Back Disorders: Investigation of a Physiotherapist and Nurse Practitioner Intervention Delivered Through Telehealth

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: NP face to face management of Chronic Low Back Pain
* Other: PT face to face management of Chronic Low Back Pain
* Other: Interprofessional Videoconferencing for Chronic Low Back Pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult 18-80 low back pain and/or related leg pain affecting function, >3 months duration Exclusion Criteria: clients within a third party payer insurance coverage system clients with primarily neck or thoracic pain clients with language or comprehension difficulties that would limit completion of paperwork

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care (NP)<br>Rural NP with client in-person, usual care | Other: NP face to face management of Chronic Low Back Pain<br>* usual NP management of chronic low back disorder<br>|
| Active Comparator: PT in-person<br>Urban PT travels to rural area to manage patient's back pain in-person. | Other: PT face to face management of Chronic Low Back Pain<br>* Includes manual therapy, education, exercise<br>|
| Active Comparator: PT/NP Telehealth<br>Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient | Other: Interprofessional Videoconferencing for Chronic Low Back Pain<br>* Includes manual therapy, education, exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term impact of patient/provider satisfaction | questionnaire | up to 2 weeks after assessment | 
| Short term outcome of patient experience with Telehealth | qualitative questionnaire | up to 2 weeks | 
| Medium term outcome of patient and provider satisfaction | questionnaire | 3 months | 
| Short term impact of patient function | Modified Oswestry Disability questionnaire | up to 2 weeks after assessment | 
| Short term impact on pain | Numeric Pain Rating Scale - questionnaire | up to 2 weeks after assessment | 
| Short term impact on quality of life | Euro-Qol health survey instrument (EQ-5D) | up to 2 weeks after assessment | 
| Medium term impact on pain | Numeric Pain Rating Scale - questionnaire | 3 months | 
| Medium term impact on quality of life | Euro-Qol health survey instrument (EQ-5D) | 3 months | 
| Medium impact on patient function | Modified Oswestry Disability Index questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness of each of 3 arms of study | patient diaries | 6 months | 
| Long term outcome on patient/provider satisfaction | questionnaire | 6 months | 
| Long term impact on quality of life | Euro-Qol health survey instrument (EQ-5D) | 6 months | 
| Long term impact on function | Modified Oswestry Disability Index questionnaire | 6 months | 
| Long term impact on pain | Numeric Pain Rating Scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, telehealth, videoconferencing, access to physical therapy, interprofessional care, rural health