Úrsula Guillén1, Amy Mackley2, Naomi Laventhal3, Stephanie Kukora3, Lori Christ4, Matthew Derrick5, Jennifer Batza5, Sarvin Ghavam6, Haresh Kirpalani4. 1. Division of Neonatology, Christiana Care Health System, Newark, DE. Electronic address: uguillen@christianacare.org. 2. Division of Neonatology, Christiana Care Health System, Newark, DE. 3. Division of Neonatal-Perinatal Medicine, University of Michigan, Ann Arbor, MI. 4. Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA. 5. Division of Neonatology, NorthShore University Health System, Evanston, IL. 6. Division of Neonatology, Virtua Voorhees Hospital, Voorhees Township, NJ.
Abstract
OBJECTIVE: To assess decisional conflict and knowledge about prematurity among mothers facing extreme premature delivery when the counseling clinicians were randomized to counsel using a validated decision aid compared with usual counseling. STUDY DESIGN: In this randomized trial, clinicians at 5 level III neonatal intensive care units in the US were randomized to supplement counseling using the decision aid or to counsel mothers in their usual manner. We enrolled mothers with threatened premature delivery at 220/7 to 256/7 weeks of gestation within 7 days of their counseling. The primary outcome was the Decisional Conflict Scale (DCS) score. One hundred mothers per group were enrolled to detect a clinically relevant effect size of 0.4 in the Decisional Conflict Scale. Secondary outcomes included knowledge about prematurity; scores on the Preparedness for Decision Making scale; and acceptability. RESULTS:Ninety-two clinicians were randomized and 316 mothers were counseled. Of these, 201 (64%) mothers were enrolled. The median gestational age was 24.1 weeks (IQR 23.7-24.9). In both groups, DCS scores were low (16.3 ± 18.2 vs 16.8 ± 17, P = .97) and Preparedness for Decision Making scores were high (73.4 ± 28.3 vs 70.5 ± 31.1, P = .33). There was a significantly greater knowledge score in the decision aid group (66.2 ± 18.5 vs 57.2 ± 18.8, P = .005). Most clinicians and parents found the decision aid useful. CONCLUSIONS: For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information. A structured decision aid may improve comprehension of complex information. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01713894.
RCT Entities:
OBJECTIVE: To assess decisional conflict and knowledge about prematurity among mothers facing extreme premature delivery when the counseling clinicians were randomized to counsel using a validated decision aid compared with usual counseling. STUDY DESIGN: In this randomized trial, clinicians at 5 level III neonatal intensive care units in the US were randomized to supplement counseling using the decision aid or to counsel mothers in their usual manner. We enrolled mothers with threatened premature delivery at 220/7 to 256/7 weeks of gestation within 7 days of their counseling. The primary outcome was the Decisional Conflict Scale (DCS) score. One hundred mothers per group were enrolled to detect a clinically relevant effect size of 0.4 in the Decisional Conflict Scale. Secondary outcomes included knowledge about prematurity; scores on the Preparedness for Decision Making scale; and acceptability. RESULTS: Ninety-two clinicians were randomized and 316 mothers were counseled. Of these, 201 (64%) mothers were enrolled. The median gestational age was 24.1 weeks (IQR 23.7-24.9). In both groups, DCS scores were low (16.3 ± 18.2 vs 16.8 ± 17, P = .97) and Preparedness for Decision Making scores were high (73.4 ± 28.3 vs 70.5 ± 31.1, P = .33). There was a significantly greater knowledge score in the decision aid group (66.2 ± 18.5 vs 57.2 ± 18.8, P = .005). Most clinicians and parents found the decision aid useful. CONCLUSIONS: For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information. A structured decision aid may improve comprehension of complex information. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01713894.
Authors: Joseph W Kaempf; Mark Tomlinson; Cindy Arduza; Shelly Anderson; Betty Campbell; Linda A Ferguson; Mara Zabari; Valerie T Stewart Journal: Pediatrics Date: 2006-01 Impact factor: 7.124
Authors: Barry D Weiss; Mary Z Mays; William Martz; Kelley Merriam Castro; Darren A DeWalt; Michael P Pignone; Joy Mockbee; Frank A Hale Journal: Ann Fam Med Date: 2005 Nov-Dec Impact factor: 5.166
Authors: Glyn Elwyn; Annette O'Connor; Dawn Stacey; Robert Volk; Adrian Edwards; Angela Coulter; Richard Thomson; Alexandra Barratt; Michael Barry; Steven Bernstein; Phyllis Butow; Aileen Clarke; Vikki Entwistle; Deb Feldman-Stewart; Margaret Holmes-Rovner; Hilary Llewellyn-Thomas; Nora Moumjid; Al Mulley; Cornelia Ruland; Karen Sepucha; Alan Sykes; Tim Whelan Journal: BMJ Date: 2006-08-14
Authors: J Colin Partridge; Alma M Martinez; Hiroshi Nishida; Nem-Yun Boo; Keng Wee Tan; Chap-Yung Yeung; Jen-Her Lu; Victor Y H Yu Journal: Pediatrics Date: 2005-08 Impact factor: 7.124
Authors: Timothy Whelan; Carol Sawka; Mark Levine; Amiram Gafni; Leonard Reyno; Andrew Willan; Jim Julian; Susan Dent; Hakam Abu-Zahra; Edmond Chouinard; Richard Tozer; Kathleen Pritchard; Ilona Bodendorfer Journal: J Natl Cancer Inst Date: 2003-04-16 Impact factor: 13.506
Authors: J A F Zupancic; H Kirpalani; J Barrett; S Stewart; A Gafni; D Streiner; M L Beecroft; P Smith Journal: Arch Dis Child Fetal Neonatal Ed Date: 2002-09 Impact factor: 5.747
Authors: Margaret H Barlet; Peter A Ubel; Kevin P Weinfurt; Hannah C Glass; Kathryn I Pollak; Debra H Brandon; Monica E Lemmon Journal: J Pediatr Date: 2022-02-26 Impact factor: 6.314
Authors: Janet Jull; Sascha Köpke; Maureen Smith; Meg Carley; Jeanette Finderup; Anne C Rahn; Laura Boland; Sandra Dunn; Andrew A Dwyer; Jürgen Kasper; Simone Maria Kienlin; France Légaré; Krystina B Lewis; Anne Lyddiatt; Claudia Rutherford; Junqiang Zhao; Tamara Rader; Ian D Graham; Dawn Stacey Journal: Cochrane Database Syst Rev Date: 2021-11-08
Authors: R Geurtzen; J F M van den Heuvel; J J Huisman; E M Lutke Holzik; M N Bekker; M Hogeveen Journal: J Perinatol Date: 2021-07-20 Impact factor: 2.521
Authors: André Kidszun; Daniel Matheisl; Susanne Tippmann; Julia Inthorn; Seyed Hamidreza Mahmoudpour; Norbert W Paul; Eva Mildenberger Journal: JAMA Pediatr Date: 2020-07-01 Impact factor: 16.193
Authors: Mariana A Carvalho; Lina Bejjani; Rossana P V Francisco; Elizabeth G Patino; Alexandre Vivanti; Fernanda S Batista; Marcelo Zugaib; Frédéric J Mercier; Lisandra S Bernardes; Alexandra Benachi Journal: PLoS One Date: 2021-02-03 Impact factor: 3.240