Improving Veteran Access to Integrated Management of Back Pain

Low Back Pain Clinical Trial

— AIM-BACK  

Official title:

Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04411420
• Other study ID #: Pro00101938
• Secondary ID: UH3AT009790
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1815
• Est. completion date: January 2025
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Clinic eligibility:

• Volunteer and return signed clinic participation agreement

• Availability of clinical personnel willing to deliver the treatment interventions (in either arm).

• Staff and location need to be distinct from other enrolled clinics.

• Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.

Participant Survey Eligibility Criteria:

Inclusion Criteria:

1. Age >= 18

2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic

3. Provider determines LBP is appropriate for conservative management

4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider

Exclusion Criteria:

1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)

2. No documented phone number in the electronic health record.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Veterans Family

Intervention

Behavioral:
• Pain modulation with physical pain treatment
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
• Telephone delivered self-management counseling for increasing physical activity
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
• Telephone delivered behavioral treatment for participants with high risk for continued disability
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
• Patient preference treatment protocol
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
• Nonpharmacological guideline adherent treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
• Facilitated referrals to existing VA or non-VA pain management resources
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

Locations

Country	Name	City	State
United States	Durham VA	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Durham VA Medical Center, National Center for Complementary and Integrative Health (NCCIH), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2. — View Citation

George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348. — View Citation

Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Reported Outcomes--Catastrophizing	Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.	Baseline, three, six, and twelve months
Other	Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)	The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate a series of alcohol use questions on a scale of 0-4 with zero representing a better outcome	Baseline, three, six, and twelve months
Other	Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool	The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome	Baseline, three, six, and twelve months
Other	Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)	Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.	Baseline, three, six, and twelve months
Other	Change in Patient Reported Outcomes--Depressed Mood	The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week.	Baseline, three, six, and twelve months
Other	Change in Patient Reported Outcomes--Quality of Life	The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EUROQUOL asks the participant a series of questions related to quality of life on a scale of 0-5.	Baseline, three, six, and twelve months
Primary	Change in Pain Interference Measure	The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.	Baseline, three months post baseline
Primary	Change in Physical Function Measure	The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with one representing a better outcome. With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.	Baseline, three months post baseline
Secondary	Change in Sleep Disturbance	The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome	Baseline, three months post baseline
Secondary	Change in Patient reported Outcomes--PROMIS Sleep Disturbance	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome	Baseline, three, six, and twelve months
Secondary	Change in Opioid Use--Chronic User	opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months	Baseline, twelve months post baseline
Secondary	Change in Opioid Use--Morphine Dose	opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months	Baseline, twelve months post baseline
Secondary	Change in Patient Reported Outcomes--PROMIS Pain Interference	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with one representing a better outcome	Baseline, three, six, and twelve months
Secondary	Change in Patient Reported Outcomes--PROMIS Physical Function	The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.	Baseline, three, six, and twelve months

External Links

•   Updated Statistical Analysis Plan Preprint