Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization

Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization- an Implementation Study

The aim of this study is to assess whether the ETMI method can be implemented among primary care practitioners in the central district of Maccabi Health Services and examine whether it provides a medical and economic advantage.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: the Enhanced Transtheoretical Model Intervention (ETMI)

Detailed Description

An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.

• Study Type: Observational
• Enrollment (Actual): 1463

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel, 40700
    • Ariel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment.

Description

Inclusion Criteria:

• primary care practitioners and their patients, who suffer from back pain and receive treatment.
• patients who suffer from back pain and receive treatment with or without leg radiation

Exclusion Criteria:

• no

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Central District; The ETMI method will be implemented in this group	Other: the Enhanced Transtheoretical Model Intervention (ETMI); ETMI consists of a physical and functional examination, a discussion about the role of physical activity matched to the patient stage of change, and guided through motivational interviewing techniques, exposure to fast walking, and goal setting. The patient receives a postcard outlining the main messages about physical activity and four simple stretches. The ETMI method consists of four parts: Creating a therapeutic alliance (communication skills and reassurance); Clear messages to the patient: Mandatory 3 sentences: (1." physical activity is the only thing that will help your back pain over time." 2. "It's easy to reduce your pain now - but the important thing is to prevent the next episode"," 3. "Your body must be strong and flexible."); Exposure to brisk walking (brisk walking in the corridor, hand by hand with the therapist) and graded activity.; Postcard with reminder messages on how to self manage the back.
North District; control
Hasharon District; control
South District; control
Jerusalem and Hasfhela District; control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ETMI Code	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar Computerized Adaptive Test (LCAT)	LCAT is a computerized adaptive test, meaning that the administration selects items from the item bank one at a time based on an administrative algorithm. The final calculated functional score ranges on a linear scale of 0-100, higher measures representing higher function. Additionally, the system predicts a risk-adjusted functional score at discharge. The adjusting is on: functional score at admission, age, sex, chronicity as number of days from onset of the treated condition, number of related surgeries, exercise history and use of medication to treat LBP.MCID for the LCAT is 3-9 points depending on the first score. LCAT has been tested for validity by comparing it to the Oswestry Low Back Pain Disability Questionnaire and has a high level of reliability in the English version (α = 0.92).Several studies have been published using the LCAT's Hebrew version.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic variables and therapeutic results	Number of primary care clinician appointments	baseline
Numeric Pain Rate Scale (NPRS)	The patient is asked to rate his pain intensity in the last 24 hours on a scale of 0-10 (10=severest pain)	baseline
Fear Avoidance Belief Questionnaire (FABQ)	It is a modification to the original version, allowing for the assessment using an Item Response Theory-based measures replacing the summative methods. The later version consists of three items, scoring 0-100, with 100 representing higher fear-avoidance, and 44 being a cut-off point between high and low values	baseline
Economic variables and therapeutic results	Number of orthopedic clinician appointments	baseline
Economic variables and therapeutic results	Number of physiotherapy appointments	baseline
Economic variables and therapeutic results	Anti-inflammatory drug dosage	baseline
Economic variables and therapeutic results	Number of imaging tests	baseline
Economic variables and therapeutic results	Number of surgeries and procedures	baseline

Collaborators and Investigators

• Sponsor: Ariel University
• Collaborators: Maccabi Healthcare Services, Israel
• Investigators: Principal Investigator: Ron Feldman, PhD Candidate, Ariel University

Publications and helpful links

General Publications

• Ben-Ami N, Chodick G, Mirovsky Y, Pincus T, Shapiro Y. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial. J Orthop Sports Phys Ther. 2017 Feb;47(2):57-66. doi: 10.2519/jospt.2017.7057.
• Canaway A, Pincus T, Underwood M, Shapiro Y, Chodick G, Ben-Ami N. Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel. BMJ Open. 2018 Apr 10;8(4):e019928. doi: 10.1136/bmjopen-2017-019928.
• Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Low Back Pain; Public Health; implementation study; Enhanced Transtheoretical Model Intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ArielURF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.
• IPD Sharing Time Frame: one year following completion of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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