1. JAMA Netw Open. 2019 Jun 5;2(6):e195009. doi: 10.1001/jamanetworkopen.2019.5009.

Effects of a Patient Activation Tool on Decision Making Between Surgery and
Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial.

Minneci PC(1), Cooper JN(1), Leonhart K(1), Nacion K(1), Sulkowski J(1), Porter
K(2), Wei L(2), Deans KJ(1).

Author information: 
(1)Center for Surgical Outcomes Research, The Research Institute at Nationwide
Children's Hospital, Columbus, Ohio.
(2)Center for Biostatistics, Department of Biomedical Informatics, The Ohio State
University College of Medicine, Columbus.

Importance: Strategies to activate and engage patients and caregivers in shared
decision making in the acute care setting may result in improved outcomes.
Objective: To determine whether a patient activation tool (PAT) can improve
decision-making and patient-centered outcomes among pediatric patients and their 
caregivers who choose between surgery and nonoperative management for their
child's appendicitis.
Design, Setting, and Participants: This single-blind, randomized clinical trial
collected data from a single tertiary children's hospital from March 1, 2014,
through April 30, 2016, with 1-year follow-up completed on May 1, 2017. Two
hundred of 236 eligible children and adolescents aged 7 to 17 years with
uncomplicated appendicitis enrolled with their caregivers. After receiving the
randomized clinical intervention, caregivers chose surgery or nonoperative
management. Data were analyzed from March 1, 2014, through May 1, 2017.
Interventions: Randomization to a scripted standardized surgical consultation
that emphasized patient choice or a scripted standardized surgical consultation
plus the PAT (a tablet-based tool that presents each treatment, encourages
participation in medical decision making, and aims at alleviating decisional
uncertainty).
Main Outcomes and Measures: Decisional self-efficacy immediately after treatment 
decision, health care satisfaction at discharge, and disability days for the
child at 1-year follow-up.
Results: Among 200 participants (median age, 12 years [interquartile range (IQR),
9-15 years]; 120 [60.0%] male), 98 were randomized to the PAT and 102 to the
standardized consultation groups. The percentages choosing nonoperative
management were similar (standardized consultation group, 42 of 102 [41.2%]; PAT 
group, 31 of 98 [31.6%]; P = .19). Immediate decisional self-efficacy was similar
in the standardized consultation and PAT groups (median score, 100 [IQR,
97.7-100] vs 100 [IQR, 95.5-100]; P = .03), which was not significant at the
planned significance level of P = .02. Total scores on health care satisfaction
at discharge were similar (median, 99 [IQR, 94.7-100] vs 98 [IQR, 91.7-100];
P = .27). Disability days at 1-year follow-up were also similar (median, 6 [IQR, 
2-11] vs 5 [IQR, 2-15]; P = .67). No difference in the failure rate of
nonoperative management at 1 year (13 of 38 [34.2%] vs 11 of 30 [36.7%]; P > .99)
or in the rate of complicated appendicitis 30 days after discharge (7 of 68
[10.3%] vs 9 of 71 [12.7%]; P = .79) occurred.
Conclusions and Relevance: In this study, a technology-based PAT did not improve 
measures of decision making for pediatric patients and caregivers needing to make
an urgent treatment decision between surgery and nonoperative management for
appendicitis. However, the overall high scores in both groups suggest that
pediatric patients and caregivers can process information in the acute care
setting and effectively participate in an informed shared decision-making process
around the need for surgery.
Trial Registration: ClinicalTrials.gov identifier: NCT02110485.

DOI: 10.1001/jamanetworkopen.2019.5009 
PMCID: PMC6563561
PMID: 31173118