Patient activation is the process of establishing a patient's willingness to take an active role in his or her care, ensuring a patient's confidence in his or her ability to manage his or her care, and providing a patient with the knowledge and skills necessary to make decisions and manage his or her own care. Previous adult studies have demonstrated that patient activation can improve healthy behaviors, increase the appropriate use of health care resources, improve patient preparedness for medical appointments, and improve the management and control of chronic illnesses such as diabetes. However, few studies have examined the effects of patient activation on decision-making and patient-centered outcomes in children, the acute care setting, or surgery. Emergency surgical interventions present stressful and difficult decisions for patients and caregivers. This is especially true in vulnerable populations such as children, in which caregivers are forced to take in large amounts of information and make quick decisions for someone other than themselves. Strategies to activate caregivers in the emergency setting through knowledge and engagement may result in improved decision-making with improved self-efficacy, confidence, and satisfaction.
To determine if a Patient Activation Tool (PAT) can activate pediatric patient-caregiver dyads to make confident, informed decisions related to the treatment of appendicitis, an acute surgical disease.
We performed a prospective, single-institution, single-blind, randomized controlled trial comparing an electronic and interactive PAT to standardized consultation. Our study population included 200 children aged 7 to 17 years with acute, uncomplicated appendicitis and their caregivers and ran from March 2014 through April 2016. Patients and their caregivers were randomized to either a scripted standardized surgical consultation alone or to a scripted standardized surgical consultation plus the PAT. A physician member of the research team administered both interventions. The scripted standardized consultation represented the best available and included an explanation of the risks and benefits of each treatment choice and of the importance of patient-caregiver preferences and values when making this treatment decision. The PAT is a tablet-based tool designed to present the risks and benefits of each treatment choice, activate the patient-caregiver dyad to participate in medical decision-making, and alleviate decisional uncertainty through a variety of media. Patients and caregivers were asked to choose either nonoperative management with antibiotics alone or surgery for the treatment of appendicitis. We followed all patients for 1 year. The primary outcomes were decision self-efficacy, health care satisfaction, and disability days. Specifically, we tested for superiority of the PAT compared with standardized surgical consultation on decisional self-efficacy and health care satisfaction and for noninferiority of the PAT on days of disability. Secondary outcomes included knowledge, decisional conflict, health-related quality of life, length of hospital stay, rate of readmission, and recurrence of appendicitis. We performed analyses considering each patient-caregiver dyad as a unit, using the caregiver's responses to all surveys. We compared dichotomous outcomes using Fisher exact tests and continuous outcomes using Wilcoxon rank sum tests. We performed subgroup comparisons based on the randomized intervention and treatment choice using Kruskal-Wallis tests for continuous variables and Fisher exact tests for categorical variables.
Ninety-eight patients were randomized to the PAT and 102 to the standardized consultation group. Decisional self-efficacy within 1 hour of making a treatment decision was higher in the standardized consultation group compared with the PAT group (median [interquartile range {IQR}], 100 [97.7-100] vs 100 [95.5-100]; = .03). The percentage of patients who chose each treatment was similar in both groups (standardized consultation: 41% antibiotics and 59% surgery; PAT: 32% antibiotics and 68% surgery; = .19). Total scores on health care satisfaction at discharge were similar between groups (median [IQR], 99 [94.7-100] vs 98 [91.7-100]; = .27). Disability days at 1 year were also similar (median [IQR], 6 [2-11] vs 5 [2-15]; = .67). We found no differences in rates of hospital readmission at 1 year (16.3% vs 18.1%; = .84) or emergency department/urgent care visits at 1 year (6.6% vs 7.2%; = 1.00). Among those patients who underwent surgery (primary choice plus failure of nonoperative management), we found no differences between the standardized consultation and PAT groups in rates of complicated appendicitis (10.3% vs 12.7%; = .79). Among those patients who chose nonoperative management we found no difference in the treatment failure rate of nonoperative management at 1 year between standardized consultation and PAT groups (34.2% vs 36.7%; = 1.00) nor in the rate of complicated appendicitis (5.3% vs 3.3%, = 1.00).
A technology-based tool did not improve measures of decision-making or patient activation for patients and families needing to make a medical treatment decision in an emergency care setting compared with a standardized consultation that emphasized patient choice. The very high median scores for decisional self-efficacy in each group indicate and the detected statistical differences may not be clinically meaningful. These results may reflect a ceiling effect of the survey instrument or that an intervention to improve decision-making in this setting may not be needed.
The PAT intervention did not improve our primary outcomes compared with standardized surgical consultation at our institution. This might have been in part due to the standardized consultation in the control group, which we designed to represent the best available standard of care, not usual care. In addition, the same physician staff members who administered the PAT administered the standardized consultation, which might have led to contamination. As such, the control group may not be an accurate reflection of usual practice across heterogeneous settings.
