General Study Questions
Patients with acute or chronic low back pain can participate in the study. Our hope is that we obtain a mixed sample of both acute and chronic cases.
No. All data collection for research purposes will occur within the electronic medical record, OR through a follow up patient survey from Duke. Sites that agree to participate will collect information during clinical visits and enter it in the record.
You will not need to get local IRB approval to participate in the study, as no one at the site will be engaged in research. Providers in your facility will be implementing a new care pathway but all research activities will be conducted by Duke and the Durham VA and covered under those IRBs, respectively. Local providers will have the opportunity to voluntarily participate in surveys and/or interviews but they are not required, and your team will not track any data beyond that which is required for usual clinical care.
The goal for each participating site is to recruit 105 patients
Participation in AIM-Back provides many benefits to health care providers and/or Veterans, including:
- Alignment of low back pain care with VA national priorities for best practice
- Streamlined access to non-pharmacological treatments
- Opportunities for professional development in state-of-the-art pain management
- Increased consistency for Veterans seeking care for low back pain
The template will be the clinic/encounter documentation in CPRS
Eligibility Questions
We are looking for clinics that have seen 800-5,000 unique patients for low back pain in the preceding year and do not share providers with other clinics in the network (e.g. if two clinics share PT staff or PCPs, only one of the two would be eligible).
Yes, PCP-based referral models are eligible
Yes, the list of eligible diagnoses and ICD10 codes was made to be very inclusive.
We would need to check the numbers and other eligibility criteria, but it is possible.
Yes, but with pragmatic trials we want to limit our exclusion criteria. Therefore, we tried to make our inclusion and exclusion criteria clinically relevant. If systemic involvement or more intense diagnostic workup is required, then it may not be appropriate to include the patient in the trial. Participant eligible for conservative care are generally eligible for AIM-Back. Eligibility criteria include the following:
o Inclusion Criteria (must meet all)
o Age >= 18
o Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
o Provider determines LBP is appropriate for conservative management
o Referred to integrated ICP pathway or CCP pathway by participating clinic provider
o Exclusion Criteria (if meet any)
o Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
o No documented phone number in the electronic health record.
Participation in another trial or study does not make your site ineligible for participation in AIM-Back. However, we would need to confirm whether or not participation in the other trial or study would affect your site’s ability to recruit for AIM-Back. Please reach out to us for more information.
To reduce the chance that patients at a clinic in one arm of AIM-Back would not receive care designed for the other arm of AIM-Back, clinics participating in AIM-Back cannot share staff (e.g., physical therapist that splits time between clinics). In this case, only one of the clinics would be eligible for participation.
Randomization/Analysis Questions
AIM-Back is considered a QI program so there won’t be any restrictions on other types of care that Veterans may receive either before, during, or after their participation in AIM-Back. We will track all of the types of services mentioned using ICD codes for VA-delivered care and also a survey for CIH modalities that may have been received outside of VA, so that we can control for any baseline differences between groups, and conduct sensitivity analyses if we observe differential rates of participation after starting an AIM-Back back pain care pathway.
Geographic location is not one of the variables that will impact randomization. The five variables impacting matching and randomization include: average pain score, average age of LBP patients, number of providers, average level of opioid exposure, and clinic location (main medical center vs. community clinic). Pathway assignment is purely based on chance unless the clinic is located at the main medical center, therefore it is possible for multiple clinics within one VA site to be assigned to the same pathway.
We are anticipating dropout and will work individually with the sites to create a system to track and follow up with patients. Tracking information will be shared with sites through periodic site reports.
Verbal informed consent will be obtained via telephone during enrollment. At the beginning of the study, centrally located Durham VA study staff will generate an opt-out letter signed by the research team that will be mailed to all potentially eligible patients enrolled in participating VA primary care clinics. The letter will describe the study and include an “opt-out” phone number if they do not wish to be contacted further. We will also include opt-out information on printed clinical program brochures that providers give patients in clinic at the time of referral.
