TY - JOUR
AU - S. Z. George
AU - C. France
AU - C. J. Coffman
AU - K. D. Allen
AU - T. A. Lentz
AU - R. North
AU - A. Choate
AU - A. P. Goode
AU - C. B. Simon
AU - J. M. Grubber
AU - H. King
AU - C. E. Cook
AU - F. J. Keefe
AU - L. A. Ballengee
AU - J. Naylor
AU - J. L. Brothers
AU - C. Stanwyck
AU - T. Linton
AU - C. Tumminello
AU - S. N. Hastings
A1 - 
AB - PURPOSE: AIM-Back is an embedded pragmatic clinical trial (ePCT) with cluster randomization designed to increase access and compare the effectiveness of two different non-pharmacological care pathways for low back pain (LBP) delivered within the Veteran Administration Health Care System (VAHCS). This manuscript describes baseline characteristics of AIM-Back participants as well as the representativeness of those referred to the AIM-Back program by sex, age, race, and ethnicity, relative to Veterans with low back pain at participating clinics. PARTICIPANTS: To be eligible for AIM-Back, Veterans were referred to the randomized pathway at their clinic by trained primary care providers (Referral cohort). Veterans from the Referral cohort that participated in the study included: 1) an Electronic Health Record (EHR) sample of Veterans enrolled in the program (i.e., attended initial AIM-Back visit with no consent required) and a Survey sample of Veterans that were consented for further study. Descriptive statistics for age, race, ethnicity, sex, high-impact chronic pain (HICP), a comorbidity measure, post-traumatic stress diagnosis (PTSD) and opioid exposure were reported for the Referral cohort and by sample; mean baseline PROMIS pain interference, physical function and sleep disturbance scores were reported by sample. Additional measures of pain, mental health and social risk were reported on the Survey sample. Participation to prevalence ratios (PPRs) were calculated for sex, age, race, and ethnicity by clinic to describe representativeness of the Referral cohort. FINDINGS TO DATE: Across 17 randomized primary care clinics, the Referral cohort included 2767 unique Veterans with n=1817 in the EHR sample, n=996 in the Survey sample and n=799 of the EHR sample (44%) were also in the Survey sample. High rates of HICP were observed in the EHR and Survey samples (>59%). Mean scores (SD) based on self-reported PROMIS Pain Interference (63.2 (6.8), 63.1 (6.6)) and PROMIS Physical Function (37.1 (5.3), 38.1 (5.8)) indicated moderate impairment in the EHR sample and Survey sample respectively. Approximately 10% of the EHR sample had documented opioid use in the year leading up to the AIM-Back referral. At most clinics, older Veterans (>=65 years) were underrepresented in the Referral cohort compared to those with LBP visits at clinics (PPRs < 0.8). FUTURE PLANS: The AIM-Back trial will conduct analysis to examine the comparative effectiveness of the two care pathways and identify individual characteristics that may improve responses to each pathway. The trial is expected to complete 12-month follow-up data collection by December 2024, with subsequent analyses and publications providing insights into optimizing non-pharmacological care for Veterans with LBP. TRIAL REGISTRATION: NCT04411420 (clinicaltrials.gov).
AD - Duke Clinical Research Institute and Department of Orthopaedic Surgery, Duke University, Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VAHCS, HSR; Department of Biostatistics and Bioinformatics, Duke University School of Medicine.; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VAHCS, HSR, Durham NC; University of North Carolina-Chapel Hill, Chapel Hill NC.; Center for the Study of Aging and Human Development, Duke University School of Medicine, Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR, Durham NC.; Duke Clinical Research Institute and Department of Orthopaedic Surgery, Durham NC.; Duke Clinical Research Institute, Center for Aging and Department of Orthopaedic Surgery, Duke University, Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR, Durham NC; Cooperative Studies Program Coordinating Center - VA Boston Health Care System.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR and Department of Population Health Sciences and Division of General Internal Medicine at Duke University, Durham NC.; Department of Psychiatry and Behavioral Sciences, Duke University, Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR; Department of Population Health Sciences, Duke University, Durham NC.; Durham VAHCS, MIRECC and Duke University, Durham NC.; Duke Clinical Research Institute, Durham NC.; Department of Rehabilitation Services, Duke University, Durham NC.; Center of Innovation to Accelerate Discovery and Practice Transformation at Durham VAHCS, HSR; Duke University School of Medicine, Division of Geriatrics; Department of Population Health Sciences, Duke University School of Medicine, Durham NC.
AN - 39649618
BT - medRxiv
C5 - Healthcare Disparities
DA - Nov 26
DO - 10.1101/2024.11.23.24317833
DP - NLM
ET - 20241126
JF - medRxiv
LA - eng
N2 - PURPOSE: AIM-Back is an embedded pragmatic clinical trial (ePCT) with cluster randomization designed to increase access and compare the effectiveness of two different non-pharmacological care pathways for low back pain (LBP) delivered within the Veteran Administration Health Care System (VAHCS). This manuscript describes baseline characteristics of AIM-Back participants as well as the representativeness of those referred to the AIM-Back program by sex, age, race, and ethnicity, relative to Veterans with low back pain at participating clinics. PARTICIPANTS: To be eligible for AIM-Back, Veterans were referred to the randomized pathway at their clinic by trained primary care providers (Referral cohort). Veterans from the Referral cohort that participated in the study included: 1) an Electronic Health Record (EHR) sample of Veterans enrolled in the program (i.e., attended initial AIM-Back visit with no consent required) and a Survey sample of Veterans that were consented for further study. Descriptive statistics for age, race, ethnicity, sex, high-impact chronic pain (HICP), a comorbidity measure, post-traumatic stress diagnosis (PTSD) and opioid exposure were reported for the Referral cohort and by sample; mean baseline PROMIS pain interference, physical function and sleep disturbance scores were reported by sample. Additional measures of pain, mental health and social risk were reported on the Survey sample. Participation to prevalence ratios (PPRs) were calculated for sex, age, race, and ethnicity by clinic to describe representativeness of the Referral cohort. FINDINGS TO DATE: Across 17 randomized primary care clinics, the Referral cohort included 2767 unique Veterans with n=1817 in the EHR sample, n=996 in the Survey sample and n=799 of the EHR sample (44%) were also in the Survey sample. High rates of HICP were observed in the EHR and Survey samples (>59%). Mean scores (SD) based on self-reported PROMIS Pain Interference (63.2 (6.8), 63.1 (6.6)) and PROMIS Physical Function (37.1 (5.3), 38.1 (5.8)) indicated moderate impairment in the EHR sample and Survey sample respectively. Approximately 10% of the EHR sample had documented opioid use in the year leading up to the AIM-Back referral. At most clinics, older Veterans (>=65 years) were underrepresented in the Referral cohort compared to those with LBP visits at clinics (PPRs < 0.8). FUTURE PLANS: The AIM-Back trial will conduct analysis to examine the comparative effectiveness of the two care pathways and identify individual characteristics that may improve responses to each pathway. The trial is expected to complete 12-month follow-up data collection by December 2024, with subsequent analyses and publications providing insights into optimizing non-pharmacological care for Veterans with LBP. TRIAL REGISTRATION: NCT04411420 (clinicaltrials.gov).
PY - 2024
ST - Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States
T1 - Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States
T2 - medRxiv
TI - Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States
U1 - Healthcare Disparities
U3 - 10.1101/2024.11.23.24317833
Y1 - 2024
ER -