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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819009
• Other study ID #: ArielURF
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2023
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1463
• Est. completion date: January 2, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Israel	Ariel University	Ariel

Sponsors (2)

Lead Sponsor	Collaborator
Ariel University	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic variables and therapeutic results	Number of primary care clinician appointments	baseline
Other	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
Other	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
Other	Economic variables and therapeutic results	Number of orthopedic clinician appointments	baseline
Other	Economic variables and therapeutic results	Number of physiotherapy appointments	baseline
Other	Economic variables and therapeutic results	Anti-inflammatory drug dosage	baseline
Other	Economic variables and therapeutic results	Number of imaging tests	baseline
Other	Economic variables and therapeutic results	Number of surgeries and procedures	baseline
Primary	ETMI Code		baseline
Secondary	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 (a = 0.92).Several studies have been published using the LCAT's Hebrew version.	baseline