ABSTRACT
BACKGROUND: Pain after orthopaedic trauma is complex, and many patients who have experienced orthopaedic trauma are at increased risk for prolonged opioid utilization after the injury. Patient-centered interventions capable of delivering enhanced education and opioid-sparing pain management approaches must be implemented and evaluated in trauma care settings to improve pain outcomes and minimize opioid-related risks. QUESTIONS/PURPOSES: Does personalized pain education and management delivered by coaches (1) improve pain-related outcomes, (2) reduce opioid consumption, and (3) improve patient-reported outcome measures (Patient-Reported Outcomes Measurement Information System [PROMIS] scores) compared to written discharge instructions on pain management and opioid safety? METHODS: This clinical trial aimed to examine the effect of a personalized pain education and management intervention, delivered by paraprofessional coaches, on pain-related outcomes and opioid consumption compared with usual care (written discharge instructions on pain management and opioid safety). Between February 2021 and September 2022, 212 patients were randomized to the intervention (49% [104]) or control group (51% [108]). A total of 31% (32 of 104) and 47% (51 of 108) in those groups, respectively, were lost before the minimum study follow-up of 12 weeks or had incomplete datasets, leaving 69% (72 of 104) and 53% (57 of 108) for analysis in the intervention and control group, respectively. Patients randomized to the intervention worked with the paraprofessional coaches throughout hospitalization after their orthopaedic injury and at their 2-, 6-, and 12-week visits with the surgical team after discharge to implement mindfulness-based practices and nonpharmacological interventions. Most participants in the final sample of 129 identified as Black (73% [94 of 129]) and women (56% [72 of 129]), the mean Injury Severity score was 8 ± 4, and one-third of participants were at medium to high risk for an opioid-use disorder based on the Opioid Risk Tool. Participants completed surveys during hospitalization and at the 2-, 6-, and 12-week follow-up visits. Surveys included average pain intensity scores over the past 24 hours measured on the pain numeric rating scale from 0 to 10 and PROMIS measures (physical functioning, pain interference, sleep disturbance). Opioid utilization, measured as daily morphine milligram equivalents, was collected from the electronic health record, and demographic and clinical characteristics were collected from self-report surveys. Groups were compared in terms of mean pain scores at at the 12-week follow-up, daily morphine milligram equivalents both during inpatient and at discharge, and mean PROMIS scores at 12 weeks of follow-up. Additionally, differences in the proportion of participants in each group achieving minimum clinically important differences (MCID) on pain and PROMIS scores were examined. For pain scores, an MCID of 2 points on the pain numeric rating scale assessing past 24-hour pain intensity was utilized. RESULTS: We found no difference between the intervention and control in terms of mean pain score at 12 weeks nor in the proportions of patients who achieved the MCID of 2 points for 24-hour average pain scores (85% [61 of 72] versus 72% [41 of 57], respectively, OR 2.2 [95% confidence interval (CI) 0.9 to 5.3]; p = 0.08). No differences were noted in daily morphine milligram equivalents utilized between the intervention and control groups during hospitalization, at discharge, or in prescription refills. Similarly, we observed no differences in the proportions of patients in the intervention and control groups who achieved the MCID on PROMIS Physical Function (81% [58 of 72] versus 63% [36 of 57], respectively, OR 2.2 [95% CI 0.9 to 5.2]; p = 0.06). We saw no differences in the proportions of patients who achieved the MCID on PROMIS Sleep Disturbance between the intervention and control groups (58% [42 of 72] versus 47% [27 of 57], respectively, OR 1.4 [95% CI 0.7 to 3.0]; p = 0.31). The proportion of patients who achieved the MCID on PROMIS Pain Interference scores did not differ between the intervention and the control groups (39% [28 of 72] versus 37% [21 of 57], respectively, OR 1.1 [95% CI 0.5 to 2.1]; p = 0.95). CONCLUSION: In this trial, we observed no differences between the intervention and control groups in terms of pain outcomes, opioid medication utilization, or patient-reported outcomes after orthopaedic trauma. However, future targeted research with diverse samples of patients at increased risk for poor postoperative outcomes is warranted to ascertain a potentially meaningful patient perceived effect on pain outcomes after working with coaches. Other investigators interested in this interventional approach may consider the coach program as a framework at their institutions to increase access to evidence-based nonpharmacological interventions among patients who are at increased risk for poor postoperative pain outcomes. Smaller, more focused programs connecting patients to coaches to learn about nonpharmacological pain management interventions may deliver a larger impact on patient's recovery and outcomes. LEVEL OF EVIDENCE: Level I, therapeutic study.
ABSTRACT
BACKGROUND: Patients with sickle cell disease (SCD) experience significant medical and psychological stressors that affect their mental health, well-being, and disease outcomes. Digital cognitive behavioral therapy (CBT) has been used in other patient populations and has demonstrated clinical benefits. Although evidence-based, nonpharmacological interventions for pain management are widely used in other populations, these treatments have not been well studied in SCD. Currently, there are no adequately powered large-scale clinical trials to evaluate the effectiveness and dissemination potential of behavioral pain management for adults with SCD. Furthermore, some important details regarding behavioral therapies in SCD remain unclear-in particular, what works best for whom and when. OBJECTIVE: Our primary goal is to compare the effectiveness of two smartphone-delivered programs for reducing SCD pain symptoms: digital CBT versus pain and SCD education (Education). Our secondary goal is to assess whether baseline depression symptoms moderate the effect of interventions on pain outcomes. We hypothesize that digital CBT will confer greater benefits on pain outcomes and depressive symptoms at 6 months and a greater reduction in health care use (eg, opioid prescriptions or refills or acute care visits) over 12 months. METHODS: The CaRISMA (Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications) study is a multisite comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute. CaRISMA is conducted at six clinical academic sites, in partnership with four community-based organizations. CaRISMA will evaluate the effectiveness of two 12-week health coach-supported digital health programs with a total of 350 participants in two groups: CBT (n=175) and Education (n=175). Participants will complete a series of questionnaires at baseline and at 3, 6, and 12 months. The primary outcome will be the change in pain interference between the study arms. We will also evaluate changes in pain intensity, depressive symptoms, other patient-reported outcomes, and health care use as secondary outcomes. We have 80% power to detect a difference of 0.37 SDs between study arms on 6-month changes in the outcomes with 15% expected attrition at 6 months. An exploratory analysis will examine whether baseline depression symptoms moderate the effect of the intervention on pain interference. RESULTS: This study will be conducted from March 2021 through February 2022, with results expected to be available in February 2023. CONCLUSIONS: Patients with SCD experience significant disease burden, psychosocial stress, and impairment of their quality of life. CaRISMA proposes to leverage digital technology and overcome barriers to the routine use of behavioral treatments for pain and depressive symptoms in the treatment of adults with SCD. The study will provide data on the comparative effectiveness of digital CBT and Education approaches and evaluate the potential for implementing evidence-based behavioral interventions to manage SCD pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04419168; https://clinicaltrials.gov/ct2/show/NCT04419168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29014.
