Lay Health Worker-Led Symptom Intervention for Older Adults With Cancer

# Lay Health Worker-Led Symptom Intervention for Older Adults With Cancer *Published: 2026 Apr 27* print. Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial. Devlin LA(1), Babineau DC(2), Merhar SL(3)(4), DeMauro SB(5)(6), Kraft WK(7), Lorch SA(5)(6), Das A(2), McDonald SA(2), Rhodes E(2), Schmidt AF(8), Trochinski L(2), Crawford M(2), Sithisarn T(9), Leeman L(10), Kovatis KZ(11), Ambalavanan N(12), Smith RW(13), Telang S(14), Tioseco JA(15), McAllister JM(16), Wexelblatt SL(16), Muniyappa B(17), Williams PK(18), Adeniyi-Jones SC(19), Hill CD(20)(21), Wright T(22), Sokol GM(23), Johnson L(24), Hall RW(25), Duncan SD(26), Puopolo K(5)(6), Dummula K(27)(28), Anderson-Berry A(29), Davis JM(30), Poindexter B(31), Young LW(32); HEAL Evaluation of Limited Pharmacotherapies for Neonatal Opioid Withdrawal Syndrome (HELP for NOWS) Consortium. Collaborators: Bass C, Hendricks E, Paul D, Chambers J, Mackley A, Rice W, Grisby C, Russell D, Tully L, Beiersdorfer T, King C, Reid C, Archer SW, Bada H, Hanna M, Wilburn A, DeGraaff S, McKinney-Whitlock B, Hobbs C, Wilson C, Thomas AE, Rakow H, Mendoza J, Tudor B, Nallu L, Connolly M, Dymacek A, Herzing K, Goodman N, Bohon E, Shockley A, Smith E, Auman J, Mazur A, Barnes S, Thomas B, Turner E, Pickett J, Leblond D, Moore S, Fulmor C, Pullaro L, Murray EJ, Kundrat ML, Pallotto A, Pearson M, Peralta-Carcelen M, Carlo WA, Gentle S, Turner S, Benz R, Owen S, Williams V, Cheathem A, Keyes A, Foster K, Scott A, Jessie M, Morris S, Nason J, Miller A, Welch-Miles R, Hemmerle M, Oberle B, VanOrmer M, Newman S, Kendall E, Abraham K, Markee S, Yonke N, Maxwell J, Beauman S, Lacy C, Palmer A, Kuan E, Dhawan M, Gambacorta MC, Snyder J, Risch M, Rosewood H, Guillet R, Riccio J, Moreland M, Jones R, Kneusel M, Casey C, Ohls RK, Fung C, Rau CA, Coleman K, McGrath KM, Loertscher MC. Author information: (1)Norton Children's Neonatology, affiliated with the University of Louisville School of Medicine, Louisville, Kentucky. (2)Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina. (3)Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Good Samaritan Hospital, Cincinnati, Ohio. (4)St Elizabeth Healthcare Edgewood Hospital, Edgewood, Kentucky. (5)Division of Neonatology, Children's Hospital of Philadelphia, Pennsylvania. (6)Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia. (7)Department of Pharmacology, Physiology & Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania. (8)Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. (9)Department of Pediatrics, Golisano Children's at University of Kentucky, Lexington. (10)Department of Family and Community Medicine, The University of New Mexico School of Medicine, Albuquerque. (11)Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, Delaware. (12)Division of Neonatology, Department of Pediatrics, The University of Alabama at Birmingham. (13)Department of Pediatrics, University of Louisville School of Medicine/Norton Women's and Children's Hospital, Louisville, Kentucky. (14)Department of Pediatrics, University of Louisville School of Medicine/Norton Children's Hospital, Louisville, Kentucky. (15)Children's Hospital of Philadelphia Newborn Care, AtlantiCare Regional Medical Center, Pomona, New Jersey. (16)Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. (17)Department of Pediatrics, Division of General Pediatrics, University of Utah School of Medicine, Salt Lake City. (18)Section of Neonatology, Department of Pediatrics, Oklahoma Children's Hospital, OU Health, University of Oklahoma Health Center, Oklahoma City. (19)Department of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University/Nemours Children's Health, Philadelphia, Pennsylvania. (20)Kettering Health, Kettering, Ohio. (21)Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. (22)Department of Pediatrics, University of South Florida, Tampa. (23)Department of Pediatrics, Indiana University School of Medicine, Indianapolis. (24)University of Rochester School of Medicine & Dentistry, Rochester, New York. (25)Department of Pediatrics/Neonatology, University of Arkansas for Medical Sciences, Little Rock. (26)Department of Pediatrics, University of Louisville School of Medicine/University of Louisville Hospital, Louisville, Kentucky. (27)Department of Pediatrics, University of Kansas Medical Center, Kansas City. (28)Children's Mercy Hospital, Kansas City, Missouri. (29)Department of Pediatrics, University of Nebraska Medical Center, Omaha. (30)Department of Pediatrics and Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts. (31)Division of Neonatology, Emory University School of Medicine, Atlanta, Georgia. (32)Larner College of Medicine at the University of Vermont, Burlington. Comment in doi: 10.1001/jama.2026.6412. Comment in doi: 10.1001/jama.2026.0759. ## IMPORTANCE Infants with neonatal opioid withdrawal syndrome (NOWS) who receive pharmacologic treatment are traditionally treated with a scheduled opioid taper. An alternate approach, symptom-based dosing, may better align treatment with withdrawal severity. ## OBJECTIVE To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach. DESIGN, SETTING, AND PARTICIPANTS In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid. Opioid dosing was guided by study-approved, site-specific algorithms. Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025. Sample size analyses were conducted between August 1, 2024, and September 23, 2024. INTERVENTION: Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing. MAIN OUTCOME AND MEASURE: Time from birth to medical readiness for discharge. ## RESULTS Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort). The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]). There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups. For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing. In the Finnegan cohort (n = 243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]). The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups). CONCLUSIONS AND RELEVANCE Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC. ## TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT05980260. DOI: 10.1001/jama.2026.5782 PMCID: PMC13110413 DOI: 10.1001/jama.2026.2851