Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Randomized Controlled Trial (TARGET Trial), 4 U.S. cities, 2016-2019 (ICPSR 38145)

Version Date: Oct 7, 2021

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Principal Investigator(s):
Anthony Delitto, University of Pittsburgh; Robert Saper, Cleveland Clinic

https://doi.org/10.3886/ICPSR38145.v1

Version V1

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Summary

The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial was a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute lower back pain (LBP) and identified as high risk for persistent disabling symptoms. Chronic lower back pain (LBP) is defined as a response of "more than three months" to question 1, and a response of "half the days or more than half the days" in the past 6 months to question 2. See Appendix 1 for the LBP Questionnaire in the Protocol report.

Study sites included primary care clinics within each of four geographical regions in the United States, with clinics randomized to either GBC or GBC+PIPT. Acute LBP patients at all clinics were risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes were the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes were LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records.

Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1,860 high-risk patients in the cluster-randomized controlled trial cohort. A prospective observational cohort of approximately 6,900 low and medium-risk acute LBP patients was enrolled concurrently.

This data collection contains a single data file with 223 variables and 9,730 cases. The number of respondents at each of the study locations were:

  • Boston Medical Center: 997 respondents
  • Intermountain Health (Salt Lake City): 2,094 respondents
  • Johns Hopkins University (Baltimore): 1,615 respondents
  • University of Pittsburg Medical Center: 5,024 respondents

Citation

Delitto, Anthony, and Saper, Robert. Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Randomized Controlled Trial (TARGET Trial), 4 U.S. cities, 2016-2019. Inter-university Consortium for Political and Social Research [distributor], 2021-10-07. https://doi.org/10.3886/ICPSR38145.v1

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Funding

Patient-Centered Outcomes Research Institute (PCS-1402-10867)

Subject Terms

Geographic Coverage

Smallest Geographic Unit

City

Restrictions

Access to the data in this collection is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2016-01-01 -- 2019-12-31

Date of Collection

2016-01-01 -- 2019-12-31

Data Collection Notes

  1. Originally, the study plan included a fifth site, Charleston, SC (Medical University of South Carolina), that was not able to successfully implement the data collection. Therefore, data are provided for only four sites: (Boston Medical Center in Boston, University of Pittsburgh Medical Center in Pittsburgh, Intermountain Health in Salt Lake City, and Johns Hopkins Medical Center in Baltimore).

  2. The Oswestry Disability Index is copyrighted. It has been removed by the principal investigators from the two accompanying reports (Protocol and Research Plan) in this data collection.

  3. This collection includes a SAS syntax file with code to help data users understand computed variables within the dataset and to replicate the principal investigators' findings. This syntax file is only available to users who apply for the data through an approved Restricted Data Use Agreement.

  4. Medical Subject Heading (MeSH) terms that apply to this study include: behavioral medicine, health services accessibility, International Classification of Diseases (ICD-10), low back pain, pain management, pain measurement, patient care, spine, tobacco use.

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Study Purpose

This study sought to assess whether the stratified approach using Psychologically Informed Physical Therapy (PIPT) matched to acute lower back pain (LBP) patients at high risk for poor outcomes

  1. is effective in the US;
  2. has the potential to prevent patients from transitioning to chronic LBP; and
  3. reduces patient exposure to unnecessary, expensive, and potentially harmful tests (e.g., MRIs), medications (e.g., opioids), and procedures (e.g., epidural steroid injections).

The research will provide guidance to patients, primary care providers, clinics, hospital systems, insurers, payers, and professional organizations responsible for clinical practice guidelines and dissemination regarding the following health decision:

Should prompt referral to evidence-based psychologically informed physical therapy be strongly recommended for high risk patients presenting with acute LBP?

Study Design

Screening questionnaires used clinic-based tablets or verbally administered questionnaires to determine eligibility with the 2-item Chronic Lower Back Pain (LBP) Questionnaire, the 9-item STarT Back to stratify risk (low, medium, high) for persistent disabling symptoms, and baseline assessment of LBP-related functional disability with the 10-item Oswestry Disability Index, version 2.1a.

Research staff mailed letters at 30 days and 150 days after the index primary care physician (PCP) visit with a brief reminder at 90 days to inform patients that the specific PCP clinics were participating in the TARGET Trial, a research study about back pain. Within those mailings, patients were provided a telephone number and email address to opt out of further contact. Six-month outcome assessments were administered by the University Center for Social and Urban Research (UCSUR) at the University of Pittsburgh for the University of Pittsburgh Medical Center, Boston Medical Center, and Johns Hopkins Medical sites; outcome assessors were blinded to intervention group. Intermountain Health obtained their own patient-reported outcome data following the same procedures. For all sites, 6-month data were collected by one of three methods:

  1. trained interviewers using a computer-assisted telephone interview (CATI) version of the questionnaires;
  2. web-based responses via a link sent in email; and
  3. return-mail responses to questionnaires mailed at 6 months to the participant's home address.

LBP-related processes of care and utilization of health care services at the index visit and over 12 months included

  1. referrals to specialists (e.g., orthopedists, neurosurgeons, physiatrists, anesthesiologists) and other health care providers (e.g., stratified approach to physical therapy (PIPT), physical therapists, chiropractors),
  2. referrals for diagnostic tests (e.g., MRIs),
  3. medication prescriptions including opioids, and
  4. invasive procedures such as epidural steroid injections and back surgery.

These data were extracted from electronic medical records at each health care system.

Sample

Primary care clinics were identified at the 4 sites. Patients were screened at the clinics for acute low back pain and followed for 12 months. Patients are nested within clinics.

Time Method

Cross-sectional

Universe

The target population for this study was adult patients 18 years or older who presented to primary care physicians (i.e., internal medicine, family practice, and geriatric medicine physicians) with a primary complaint of acute low back pain (LBP) and a confirmatory primary encounter or odering diagnosis of back pain reflected in the Electronic Medical Record based on the International Classification of Diseases, Ninth Revision (ICD-9) or the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

Unit(s) of Observation

Individual

Data Type(s)

Mode of Data Collection

Description of Variables

The dataset focuses on the following major areas and question topics:

  • 40 variables to list individual ICD-10 codes
  • 20 variables repeated over five (5) time frames since the index visit providing the number of prescriptions (7), referrals (11), and imaging orders (2)
  • 20 variables asking who the patient saw or what services were received up to 12 months after the index visit (dichotomous: None / 1 or more)
  • 9 item STarT Back Item scale (dichotomous: Disagree / Agree)
  • 10 item Oswestry Disability Index at index visit and at 6 month visit (6 response options)
  • 6 variables for demographics (age, sex, race, ethnicity, height, weight)
  • 3 variables for smoking / tobacco use status

    • Presence of Common Scales

    • 10-item Oswestry Disability Index
    • 9-item Subgroups for Targeted Treatment (STarT) Back Screening Tool for Risk Stratification
    • 2-item Chronic Low Back Pain Questionnaire

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    Original Release Date

    2021-10-07

    Version History

    2021-10-07 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:

    • Checked for undocumented or out-of-range codes.
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    Weight

    None

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    Notes

    • The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.

    • One or more files in this data collection have special restrictions. Restricted data files are not available for direct download from the website; click on the Restricted Data button to learn more.