Clinical trial NCT02225535: Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
telehealth
videoconferencing
access to physical therapy
interprofessional care
rural health
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
name: Ralston Brothers Grant (Kelsey Trail Health Region)
First posted: 2014-08-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short term impact of patient/provider satisfaction
timeFrame: up to 2 weeks after assessment
measure: Short term outcome of patient experience with Telehealth
timeFrame: up to 2 weeks
measure: Medium term outcome of patient and provider satisfaction
timeFrame: 3 months
measure: Short term impact of patient function
timeFrame: up to 2 weeks after assessment
measure: Short term impact on pain
timeFrame: up to 2 weeks after assessment
measure: Short term impact on quality of life
timeFrame: up to 2 weeks after assessment
measure: Medium term impact on pain
timeFrame: 3 months
measure: Medium term impact on quality of life
timeFrame: 3 months
measure: Medium impact on patient function
timeFrame: 3 months
Secondary outcomes:
measure: Cost effectiveness of each of 3 arms of study
timeFrame: 6 months
measure: Long term outcome on patient/provider satisfaction
timeFrame: 6 months
measure: Long term impact on quality of life
timeFrame: 6 months
measure: Long term impact on function
timeFrame: 6 months
measure: Long term impact on pain
timeFrame: 6 months
Other outcomes:
measure: Barriers and facilitators to use of Telehealth
timeFrame: 2 weeks
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: School of Physical Therapy, University of Saskatchewan
name: Brenna Bath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bath B, Lovo Grona S, Milosavljevic S, Sari N, Imeah B, O'Connell ME. Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 9;5(4):e212. doi: 10.2196/resprot.5914.