Implementation of the STarT Back Screening Tool

Implementing the STarT Back Model of Stratifying Care for Patients With Low Back Pain Seeking Care in an Emergency Department: a Prospective Longitudinal Cohort Study

The STarT Back Screening Tool (SBST) has been used in different healthcare settings in order to stratify the management of patients with low back pain. However, to date, no study has investigated the feasibility of implementing the SBST in emergency departments. The objective of this study will be to test the implementation of the SBST in the stratification of patients seeking care in emergency departments.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: STarT Back Screening Tool Approach

Detailed Description

The Start Back Screening Tool (SBST) aims to identify and stratify primary care patients by using modifiable prognostic indicators that are relevant in clinical decision making. The objective of this study will be to test the feasibility of the implementation of the SBST in the stratification of patients seeking care in emergency departments. Study design: A prospective longitudinal cohort study with a 6-month follow-up. Intervention: At 6-weeks after baseline consultation, patients will be targeted to the specific treatment according to their subclassification in the SBST tool: education about pain neurophysiology and physical therapy. This is the first study that will provide results about logistic processes of the implementation of the SBST in the emergency sector, present feasibility data for the conduction of a large randomized controlled trial of subgroups of low back pain.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• We will include patients with back pain seeking care in emergency departments

Exclusion Criteria:

• We will exclude patients with serious spinal pathologies (such as cancer, fractures, inflammatory and infectious diseases) as well as pregnant patients and patients with nerve root compromise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: STarT Back Screening Tool Approach; After baseline consultation, all patients will receive usual care from their medical doctors as well as an educational booklet and weekly videos containing information on the prognosis of back pain and how patients could deal with their problems. Six weeks after baseline consultation all patients will be screened by the STarT Back Screening Tool (SBST) and will receive a stratified care according to their SBST classification.

Other: STarT Back Screening Tool Approach; Patients classified as low risk of persistent pain will be educated about their condition and how to manage their back pain by targeting modifiable prognostic factors. Patients classified as medium risk will receive evidence-based physical therapy. Patients classified as high risk will receive evidence-based physical therapy as well as individualized psychological intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Adoption at 6 weeks (i.e. at the implementation of treatment after stratification)
Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Adequacy at 3 months.
Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Fidelity at 3 months.
Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Feasibility at 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measured by a 0-10 Pain Numerical Rating Scale	Pain intensity will be measured by an 11-point (0-10) Pain Numerical Rating Scale (Pain NRS). Higher scores indicates higher pain intensity.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Disability measured by the 0-24 Roland Morris Disability Questionnaire	Disability will be measured by the 24-item Roland Morris Disability Questionnaire. Higher scores indicates higher disability.	6 weeks and 3 and 6 months after first consultation at the emergency department.
Risk of persistent disability measured by the 0-9 Start Back Screening Tool.	Risk of persistent disability will be measured using the 0-9 point Start Back Screening Tool. The higher the score the higher is the risk of persistent disability.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Global Impression of Recovery measured by the -5 to + 5 Global Perceived Effect Scale.	Global Impression of Recovery will be measured using the 11-item Global Perceived Effect Scale. Positive values represents recovery and negative values represents deterioration of symptoms.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Recovery from pain	Recovery from pain will be measured using a yes/no question (i.e. Were you completely free of back pain over the last month?)	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Depressive symptoms over the last week.	Depression will be measured by a single question on how depressed patients were over the last week (measured on a 0-10 likert scale)	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Recurrence of low back pain symptoms	Patients who recovered will be asked if they have experience a recurrence of symptoms	6 weeks and 3 and 6 months after first consultation at the emergency department.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Out of pocket costs associated with low back pain	Out of pocket costs will be measured using a 9-dimension cost diary	6 weeks and 3 and 6 months after first consultation at the emergency department.

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Principal Investigator: Luciola Costa, PhD, Universidade Cidade de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; emergency; feasibility; implementation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Unicid20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We can share our dataset upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No