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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: PT face to face management of Chronic Low Back Pain; Other: NP face to face management of Chronic Low Back Pain; Other: Interprofessional Videoconferencing for Chronic Low Back Pain

• Registration Number: NCT02225535
• Lead Sponsor: University of Saskatchewan

Brief Summary

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:

1. in-person PT assessment, where the PT travels from an urban center

2. 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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-26
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PT in-person	PT face to face management of Chronic Low Back Pain	Urban PT travels to rural area to manage patient's back pain in-person.
Usual Care (NP)	NP face to face management of Chronic Low Back Pain	Rural NP with client in-person, usual care
PT/NP Telehealth	Interprofessional Videoconferencing for Chronic Low Back Pain	Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada