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NCT Number: NCT04819009

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ariel University

Ariel, 40700, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the Enhanced Transtheoretical Model Intervention (ETMI)

Other

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.

Primary outcomes

  1. ETMI Code

    Time frame: baseline

Secondary outcomes

  1. Lumbar Computerized Adaptive Test (LCAT)

    Time frame: baseline

    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.

Other outcomes

  1. Economic variables and therapeutic results

    Time frame: baseline

    Number of primary care clinician appointments

  2. Numeric Pain Rate Scale (NPRS)

    Time frame: baseline

    The patient is asked to rate his pain intensity in the last 24 hours on a scale of 0-10 (10=severest pain)

  3. Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: baseline

    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

  4. Economic variables and therapeutic results

    Time frame: baseline

    Number of orthopedic clinician appointments

  5. Economic variables and therapeutic results

    Time frame: baseline

    Number of physiotherapy appointments

  6. Economic variables and therapeutic results

    Time frame: baseline

    Anti-inflammatory drug dosage

  7. Economic variables and therapeutic results

    Time frame: baseline

    Number of imaging tests

  8. Economic variables and therapeutic results

    Time frame: baseline

    Number of surgeries and procedures

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 26, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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