Improving Veteran Access to Integrated Management of Back Pain (AIM-BACK)

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

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

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.

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.

The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.

The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.

The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

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.

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

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.

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

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

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine 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

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

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

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine 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

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine 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.

Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.

The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, nine 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

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, nine 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

Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.

The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, nine 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.

The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, nine 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.

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: Age >= 18 Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic Provider determines LBP is appropriate for conservative management Referred to integrated ICP pathway or CCP pathway by participating clinic provider Exclusion Criteria: Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults) No documented phone number in the electronic health record.

Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.

The data and other resources referenced will be available one year after the date of publication for the primary analyses, which is in alignment with the VA Office of Research and Development.

We plan on using a de-identified dataset is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case by case basis. Requirements include: data will be used for research purposes and not to identify subjects data must be secured using appropriate computer technology data must be destroyed or returned after any analysis are complete authors of any manuscript resulting from this data must acknowledge the source of the data analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap coauthors must be given a chance for review and approval of a draft manuscript prior to submission