scholarly journals Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_2) ◽  
pp. S62-S72
Author(s):  
Steven Z George ◽  
Cynthia J Coffman ◽  
Kelli D Allen ◽  
Trevor A Lentz ◽  
Ashley Choate ◽  
...  
Keyword(s):  
Back Pain ◽  
Randomized Trial ◽  
Short Form ◽  
Integrated Management ◽  
Cluster Randomized Trial ◽  
Care Utilization ◽  
Measurement Information ◽  
Care Pathways ◽  
Patient Reported ◽  
Cluster Randomized

Abstract Background Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. Design The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. Summary AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

scholarly journals Effect of Peer-Based Low Back Pain Information and Reassurance at the Workplace on Sick Leave: A Cluster Randomized Trial

2013 ◽  
Vol 23 (2) ◽  
pp. 209-219 ◽  
Author(s):  
Magnus Odeen ◽  
Camilla Ihlebæk ◽  
Aage Indahl ◽  
Marjon E. A. Wormgoor ◽  
Stein A. Lie ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Sick Leave ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Low Back ◽  
Cluster Randomized

Adolescent Stress Treatment Study: A Cluster Randomized Trial

2018 ◽  
Vol 28 (7) ◽  
pp. 795-811 ◽  
Author(s):  
Stephanie Lynch ◽  
Conni DeBlieck ◽  
Linda C. Summers ◽  
Anita Reinhardt ◽  
Wanda Borges
Keyword(s):  
High School ◽  
High School Students ◽  
Randomized Trial ◽  
Stress Reduction ◽  
Short Form ◽  
Cluster Randomized Trial ◽  
School Students ◽  
Stress Treatment ◽  
Adolescent Stress ◽  
Cluster Randomized

High school students experience a variety of stressors. Mental health issues are critical to their health. The “Adolescent Stress Treatment (AST) Study: A Cluster Randomized Trial” compared the efficacy of two stress reduction devices, the EnergyPod™ and the SleepWing™. The EnergyPod™ is a device that provides a semiprivate acoustical and visual environment for rest, stress reduction, and sleep. The SleepWing™ is a smaller device offering similar benefits. High school students were offered the opportunity to participate in the AST study when they exhibited signs of agitation. The students completed the Profile of Mood States–Short Form (POMS-SF) pre- and postintervention. Total Mood Disturbance (TMD) was measured from the POMS-SF and significant improvement postintervention ( p < .001), regardless of intervention used. POMS-SF subscales were all significantly improved no matter which device was used. All participants in the study dramatically improved their mood after being in either therapeutic device.

Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.

2021 ◽  
Vol 39 (36_suppl) ◽  
pp. 349527-349527
Author(s):  
Ethan Basch ◽  
Deborah Schrag ◽  
Jennifer Jansen ◽  
Sydney Henson ◽  
Angela M. Stover ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Symptom Monitoring ◽  
Community Oncology ◽  
Electronic Alerts ◽  
Patient Reported ◽  
Cluster Randomized

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

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