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

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.