Cynthia R. Long

Evidence on recruitment strategies for Veterans Health Administration (VA) pragmatic clinical trials (PCTs) is scarce. This study compares multiple approaches and evaluates engagement, efficiency, and representativeness in the integrated care setting of VA. We examined recruitment and screening processes used in the Veterans Response to Dosage in Chiropractic Therapy (VERDICT) PCT. Veterans with chronic low back pain were recruited and enrolled in 4 US VA facilities from February 2021 to May 2024. We used 3 recruitment strategies: existing referrals for chiropractic services, electronic health record (EHR) prescreen, and self-referral. Pre-enrollment contacts occurred through postal mail, email, and in-person or virtual baseline visits. We used 5 sequential screening steps leading to final eligibility determination: (1) identify and notify, (2) phone screen, (3) consent, (4) eligibility questions, and (5) chiropractic consultation. We screened 3667 veterans: 91% were identified through existing referrals, 7% through EHR prescreen, and 2% through self-referral; 62% received postal-only recruitment materials, 38% received a combination of postal + email materials, and 83% had a virtual baseline visit. Over 39 months, 766 individuals were enrolled and randomized. Due to limited VA chiropractic clinic capacity, 19% of eligible veterans were not enrolled. Across all steps of the screening process, 45% were not interested, and 35% were ineligible. Using existing referrals was the most efficient strategy, with a median time from notification to randomization of 23 days. Those emailed invitations had a median response time of 16 days, compared with 30 days for postal-only invitations. The existing referrals strategy was the most effective for recruiting racial and ethnic minorities (33%). EHR prescreen resulted in the highest proportion of female veterans (79%). This study is among the few to compare multiple recruitment strategies in a VA PCT while assessing engagement, efficiency, and representativeness. VERDICT shows that PCTs can overcome recruitment challenges through adaptable, multifaceted approaches. By addressing systemic barriers and implementing email and virtual strategies, we improved recruitment engagement and diversity. These methods can inform recruitment for trials in other VA-based and real-world settings. Clinical trial registration number: NCT04087291. Participant enrollment began on February 22, 2021, and ended on May 10, 2024. Registered on August 27, 2019.

Background: Veteran Response to Dosage in Chiropractic Therapy (VERDICT) was a pragmatic randomized trial testing chiropractic dosage effects in 766 veterans with chronic low back pain (CLBP) of ≥ 3 months. This cross-sectional analysis compares baseline characteristics of younger (18-to-64 years) and older veterans (≥ 65 years). Methods: Data were collected from February 22, 2021 to May 21, 2025 via electronic health records and REDCap questionnaires. Descriptive statistics and tests of group differences were performed using SAS. Results: VERDICT enrolled 188 older veterans (25%; mean 72 years) and 578 younger veterans (75%; mean 44 years). More female (24.7% vs. 10.6%, p < .001), Black (18.9% vs. 12.2%), and Hispanic (11.8% vs. 3.7%, p = .001) veterans comprised the younger cohort. Employment differed (p < .001) with older veterans retired (78.2% vs. 14.2%) and younger veterans employed (59% vs. 16.5%). About 14% lived rurally and period of military service was similar. Pain profiles were similar between younger and older veterans for > 5 years duration (78.4% vs. 73.4%), high-impact chronic pain (64.5% vs. 62.2%), mean pain interference [63.8(4.8) vs. 63.2(5.0)], and mean back-related disability (primary outcome) [11.9(5.2) vs. 13.3(4.9)]. Younger veterans scored significantly higher than older veterans for depression (44.8% vs. 31.4%, p = .001), anxiety (41.5% vs. 20.7%, p < .001), post-traumatic stress (38.4% vs. 17.6%, p < .001), sleep disturbance (57.1% vs. 34.6%, p < .001), and high-risk alcohol use (25.4% vs. 18.1%, p = .05). Previous chiropractic use was similar (younger 75.4% vs. older 80.3%). Medications in past 3 months differed with younger veterans reporting cannabis (25.8% vs. 12.8%, p < .001) and muscle relaxants (31.7% vs. 17.6%, p < .001) and more older veterans reporting acetaminophen (63.3% vs. 49.3%, p < .001) and gabapentin (34% vs. 20.1%, p < .001). NSAIDs use was highest among both younger (62.8%) and older (56.9%) veterans. While two-thirds had tried exercise in the past 3 months, only 16% reported exercising for their pain condition, with older veterans more likely to report providers encouraging physical activity. Conclusions: Similar pain profiles were reported among older and younger veterans seeking chiropractic care for CLBP within a clinical trial. However, potentially important age differences were noted in demographics, mental health and substance use, and CLBP treatments. Trial registration: ClinicalTrials.gov: NCT04087291. Date of Registration: 9/12/2019. Enrollment Duration: 2/22/2021 (first participant enrolled) through 5/10/2024 (last participant enrolled).

Objective We evaluate change in low back pain (LBP) intensity and interference as the mechanism by which chiropractic care affects other biopsychosocial factors in US active-duty military members. Design We conducted secondary, exploratory mediation analysis of pragmatic, multisite, clinical trial (NCT01692275) post results using natural effect modeling. Mediators were the 6-week values of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 pain interference and intensity. Outcomes were 12-week values of other PROMIS-29 biopsychosocial subdomains. Models evaluated overall and individual factor contribution and were adjusted for baseline age, sex, LBP duration, LBP intensity and mediator and outcome values. Setting Three US military treatment facilities. Participants 750 US active-duty military members with LBP. Interventions Trial participants received 6 weeks of treatment with chiropractic care plus usual medical care or usual medical care alone. Results In multiple mediator models, pain interference and pain intensity explained much of the effect of chiropractic care on physical function (proportion mediated=0.77, 95% CI 0.43 to 2.0), fatigue (0.62, 95% CI 0.30 to 1.0), sleep disturbance (0.49, 95% CI 0.31 to 1.5) and social roles (0.81, 95% CI 0.50 to 2.0). Mental health was not evaluable due to the low prevalence of symptoms reported. The combined models of pain interference and pain intensity did not have a higher proportion mediated than the individual pain intensity models except for fatigue outcome models. Conclusion Pain intensity appeared to be the mechanism by which much of the change in biopsychosocial factors occurred and should be considered a key clinical indicator for improvement in biopsychosocial health when chiropractic care is added to usual medical care for US active-duty military members.

The purpose of this study was to determine whether patient characteristics were associated with face-to-face (F2F) and telehealth visits for those receiving chiropractic care for musculoskeletal conditions in the US Veterans Health Administration (VHA) during the COVID-19 pandemic. A retrospective cross-sectional analysis of all patients (veterans, dependents, and spouses) who received chiropractic care nationwide at the VHA from March 1, 2020, to February 28, 2021, was performed. Patients were allocated into 1 of the following 3 groups: only telehealth visits, only F2F visits, and combined F2F and telehealth visits. Patient characteristics included age, sex, race, ethnicity, marital status, and Charlson Comorbidity Index. Multinomial logistic regression estimated associations of these variables with visit type. The total number of unique patients seen by chiropractors between March 2020 and February 2021 was 62 658. Key findings were that patients of non-White race and Hispanic or Latino ethnicity were more likely to attend telehealth-only visits (Black [odds ratio 1.20, 95% confidence interval {1.10-1.31}], other races [1.36 {1.16-1.59}], and Hispanic or Latino [1.35 {1.20-1.52}]) and combination telehealth and F2F care (Black [1.32 {1.25-1.40}], other races [1.37 {1.23-1.52}], and Hispanic or Latino [1.63 {1.51-1.76}]). Patients younger than 40 years of age were more likely to choose telehealth visits ([1.13 {1.02-1.26}], 66-75 years [1.17 {1.01-1.35}], and >75 years [1.26 {1.06-1.51}] vs those 40-55 years of age). Sex, visit frequency, and Charlson Comorbidity Index showed significant relationships as well, while marital status did not. During the COVID-19 pandemic, VHA patients with musculoskeletal complaints using chiropractic telehealth were more ethnically and racially diverse than those using F2F care alone.

Background: Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. Methods: This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. Results: We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22–79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1–7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. Conclusions: We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. Trial registration: ClinicalTrials.gov NCT03254719

Background: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. Methods: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. Results: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized approach to outcomes measures). The online data collection domain included 2 themes/4 subthemes: user concerns (little difficulty vs. form challenges, required computer skills); and technology issues (computer/internet access, junk mail). Clinical trial planning domain included 2 themes/5 subthemes: participant recruitment (altruistic service by veterans, awareness of chiropractic availability, financial compensation); and communication methods (preferences, potential barriers). Conclusions: This qualitative study highlighted veteran stakeholders’ perceptions of VA-based chiropractic services and offered important suggestions for conducting a full-scale, veteran-focused, randomized trial of multimodal chiropractic care for chronic LBP in this clinical setting. Trial registration: ClinicalTrials.gov NCT03254719

The purpose of this study was to describe the use of face-to-face and telehealth chiropractic care in the U.S. Veterans Health Administration (VHA) before and after the declaration of the COVID-19 pandemic. A cross-sectional study was performed of VHA administrative data, including monthly numbers of unique patients and visits for face-to-face and telehealth (synchronous video or telephone) chiropractic care from October 1, 2019, to March 31, 2021. During the pre-pandemic phase (October 2019 to February 2020), a mean of 28 930 (SD 289) total monthly visits were conducted face-to-face (99.9%). In March 2020, total monthly visits decreased to 17.0% of the pre-pandemic average, 25.0% being face-to-face, with over a 200-fold increase in telehealth visits (rising to 1331 visits) compared to the pre-pandemic average. April showed the lowest number of face-to-face visits at (4094). May-October 2020 showed that face-to-face visits increase on average by 70.7% per month, while telehealth visits averaged 17.3% per month. October-February 2020 had total monthly visits plateau at a mean of 22 250 (76.9% of the pre-pandemic average). Telehealth visits reduced to a mean of 1245 monthly visits over this 5-month period, a drop of -5.6% of the average of monthly visits. In March 2021, total monthly visits (31 221) exceeded the pre-pandemic average for the first time since January 2020; 4.0% remained in telehealth. Face-to-face visits decreased early in the pandemic but increased after May 2020. Chiropractic telehealth use rapidly increased during the early stage of the COVID-19 pandemic, and decreased later, but remained slightly higher than pre-pandemic levels.

The purpose of this study was to describe the diagnoses and chiropractic services performed by doctors of chiropractic operating within 3 military treatment facilities for patients with low back pain (LBP). This was a descriptive secondary analysis of a pragmatic clinical trial comparing usual medical care (UMC) plus chiropractic care to UMC alone for U.S. active-duty military personnel with LBP. Participants who were allocated to receive UMC plus 6 weeks of chiropractic care and who attended at least 1 chiropractic visit (n = 350; 1547 unique visits) were included in this analysis. International Classification of Diseases and Current Procedural Terminology codes were transcribed from chiropractic treatment paper forms. The number of participants receiving each diagnosis and service and the number of each service on unique visits was tabulated. Low back pain and co-occurring diagnoses were grouped into neuropathic, nociceptive, bone and/or joint, general pain, and nonallopathic lesions categories. Services were categorized as evaluation, active interventions, and passive interventions. The most reported pain diagnoses were lumbalgia (66.1%) and thoracic pain (6.6%). Most reported neuropathic pain diagnoses were sciatica (4.9%) and lumbosacral neuritis or radiculitis (2.9%). For the nociceptive pain, low back sprain and/or strain (15.8%) and lumbar facet syndrome (9.2%) were most common. Most reported diagnoses in the bone and/or joint category were intervertebral disc degeneration (8.6%) and spondylosis (6.0%). Tobacco use disorder (5.7%) was the most common in the other category. Chiropractic care was compromised of passive interventions (94%), with spinal manipulative therapy being the most common, active interventions (77%), with therapeutic exercise being most common, and a combination of passive and active interventions (72%). For the sample in this study, doctors of chiropractic within 3 military treatment facilities diagnosed, managed, and provided clinical evaluations for a range of LBP conditions. Although spinal manipulation was the most commonly used modality, chiropractic care included a multimodal approach, comprising of both active and passive interventions a majority of the time.