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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7J4W3
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care (NP); Rural NP with client in-person, usual care	Other: NP face to face management of Chronic Low Back Pain; usual NP management of chronic low back disorder
Active Comparator: PT in-person; 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; Includes manual therapy, education, exercise
Active Comparator: PT/NP Telehealth; Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient	Other: Interprofessional Videoconferencing for Chronic Low Back Pain; Includes manual therapy, education, exercise.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers and facilitators to use of Telehealth	questionnaire	2 weeks

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Health Research Foundation; Ralston Brothers Grant (Kelsey Trail Health Region)
• Investigators: Principal Investigator: Brenna Bath, PhD, School of Physical Therapy, University of Saskatchewan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; telehealth; rural health; interprofessional care; videoconferencing; access to physical therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Bio13-241