Clinical trial NCT04411420: Improving Veteran Access to Integrated Management of Back Pain
Official title: Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Veterans Family
Keywords: clinical pathway
veterans
low back pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Durham VA Medical Center
name: University of North Carolina, Chapel Hill
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-06-02
Enrollment: 1815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics.

We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Interference Measure
timeFrame: Baseline, three months post baseline
measure: Change in Physical Function Measure
timeFrame: Baseline, three months post baseline
Secondary outcomes:
measure: Change in Sleep Disturbance
timeFrame: Baseline, three months post baseline
measure: Change in Patient reported Outcomes--PROMIS Sleep Disturbance
timeFrame: Baseline, three, six, and twelve months
measure: Change in Opioid Use--Chronic User
timeFrame: Baseline, twelve months post baseline
measure: Change in Opioid Use--Morphine Dose
timeFrame: Baseline, twelve months post baseline
measure: Change in Patient Reported Outcomes--PROMIS Pain Interference
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--PROMIS Physical Function
timeFrame: Baseline, three, six, and twelve months
Other outcomes:
measure: Change in Patient Reported Outcomes--Catastrophizing
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--Depressed Mood
timeFrame: Baseline, three, six, and twelve months
measure: Change in Patient Reported Outcomes--Quality of Life
timeFrame: Baseline, three, six, and twelve months
Locations:
city: Durham
country: United States
facility: Durham VA
state: North Carolina
Study officials:
affiliation: Duke University / Durham VA
name: Susan N Hastings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Steven Z George, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.