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

Peter C Minneci, Jennifer N Cooper, Karen Leonhart, Kristine Nacion, Jason Sulkowski, Kyle Porter, Lai Wei, Katherine J Deans, Peter C Minneci, Jennifer N Cooper, Karen Leonhart, Kristine Nacion, Jason Sulkowski, Kyle Porter, Lai Wei, Katherine J Deans

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Minneci reported receiving funding awards from the Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study and outside the submitted work. Dr Cooper reported salary support from PCORI awards during the conduct of the study. Ms Leonhart reported salary support from PCORI awards during the conduct of the study. Dr Deans reported receiving funding awards from PCORI during the conduct of the study and outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Flow Diagram
Figure.. CONSORT Flow Diagram

References

    1. Barry MJ, Edgman-Levitan S. Shared decision making: pinnacle of patient-centered care. N Engl J Med. 2012;366(9):-. doi:10.1056/NEJMp1109283
    1. US Department of Defense. Patient activation reference guide: module 1: the patient activation continuum. 2012. . Accessed May 1, 2019.
    1. Greene J, Hibbard JH, Tusler M. How Much Do Health Literacy and Patient Activation Contribute to Older Adults’ Ability to Manage Their Health? Washington, DC: AARP Public Policy Institute; 2005.
    1. Hibbard JH, Cunningham PJ. How engaged are consumers in their health and health care, and why does it matter? Res Brief. 2008;8(8):1-9.
    1. Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007;30(1):21-29. doi:10.1097/00004479-200701000-00005
    1. Rask KJ, Ziemer DC, Kohler SA, Hawley JN, Arinde FJ, Barnes CS. Patient activation is associated with healthy behaviors and ease in managing diabetes in an indigent population. Diabetes Educ. 2009;35(4):622-630. doi:10.1177/0145721709335004
    1. Remmers C, Hibbard J, Mosen DM, Wagenfield M, Hoye RE, Jones C. Is patient activation associated with future health outcomes and healthcare utilization among patients with diabetes? J Ambul Care Manage. 2009;32(4):320-327. doi:10.1097/JAC.0b013e3181ba6e77
    1. Skolasky RL, Green AF, Scharfstein D, Boult C, Reider L, Wegener ST. Psychometric properties of the patient activation measure among multimorbid older adults. Health Serv Res. 2011;46(2):457-478. doi:10.1111/j.1475-6773.2010.01210.x
    1. Chappuy H, Taupin P, Dimet J, Claessens YE, Tréluyer JM, Chéron G; Groupe Francophone de Réanimation & Urgences Pédiatriques . Do parents understand the medical information provided in paediatric emergency departments? a prospective multicenter study. Acta Paediatr. 2012;101(10):1089-1094. doi:10.1111/j.1651-2227.2012.02763.x
    1. Horowitz L, Kassam-Adams N, Bergstein J. Mental health aspects of emergency medical services for children: summary of a consensus conference. J Pediatr Psychol. 2001;26(8):491-502. doi:10.1093/jpepsy/26.8.491
    1. Kassam-Adams N, Fleisher CL, Winston FK. Acute stress disorder and posttraumatic stress disorder in parents of injured children. J Trauma Stress. 2009;22(4):294-302. doi:10.1002/jts.20424
    1. Katan M, Christ-Crain M. The stress hormone copeptin: a new prognostic biomarker in acute illness. Swiss Med Wkly. 2010;140:w13101.
    1. Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK. The impact of disease severity on the informed consent process in clinical research. Am J Med. 1996;100(3):261-268. doi:10.1016/S0002-9343(97)89483-1
    1. Smithline HA, Mader TJ, Crenshaw BJ. Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? Acad Emerg Med. 1999;6(8):776-780. doi:10.1111/j.1553-2712.1999.tb01205.x
    1. Wray J, Lee K, Dearmun N, Franck L. Parental anxiety and stress during children’s hospitalisation: the StayClose study. J Child Health Care. 2011;15(3):163-174. doi:10.1177/1367493511408632
    1. Minneci PC, Mahida JB, Lodwick DL, et al. Effectiveness of patient choice in nonoperative versus surgical management of pediatric uncomplicated acute appendicitis. JAMA Surg. 2016;151(5):408-415. doi:10.1001/jamasurg.2015.4534
    1. Minneci PC, Sulkowski JP, Nacion KM, et al. . Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014;219(2):272-279. doi:10.1016/j.jamcollsurg.2014.02.031
    1. Bunn H, O’Connor A. Validation of client decision-making instruments in the context of psychiatry. Can J Nurs Res. 1996;28(3):13-27.
    1. O’Connor A. User manual: Decision Self-efficacy Scale. Ottawa Hospital Research Institute. . Modified 2002. Accessed May 1, 2019.
    1. Cranney A, O’Connor AM, Jacobsen MJ, et al. . Development and pilot testing of a decision aid for postmenopausal women with osteoporosis. Patient Educ Couns. 2002;47(3):245-255. doi:10.1016/S0738-3991(01)00218-X
    1. Varni JW, Burwinkle TM, Dickinson P, et al. . Evaluation of the built environment at a children’s convalescent hospital: development of the Pediatric Quality of Life Inventory parent and staff satisfaction measures for pediatric health care facilities. J Dev Behav Pediatr. 2004;25(1):10-20. doi:10.1097/00004703-200402000-00002
    1. Varni JW, Quiggins DJL, Ayala GX. Development of the Pediatric Hematology/Oncology Parent Satisfaction Survey. Child Health Care. 2000;29(4):243-255. doi:10.1207/S15326888CHC2904_2
    1. Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O’Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010;78(1):130-133. doi:10.1016/j.pec.2009.05.012
    1. O’Connor A, Jacobsen MJ, Elmslie T, et al. . Simple vs complex patient decision aids: is more necessarily better? Med Decis Making. 2000;20(4):A496.
    1. Stacey D, O’Connor AM, DeGrasse C, Verma S. Development and evaluation of a breast cancer prevention decision aid for higher-risk women. Health Expect. 2003;6(1):3-18. doi:10.1046/j.1369-6513.2003.00195.x
    1. O’Connor A. User manual: Decisional Conflict. . Updated 2010. Accessed August 13, 2012.
    1. Pennarola BW, Rodday AM, Mayer DK, et al. ; HSCT-CHESS Study . Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012;69(2):194-214. doi:10.1177/1077558711431460
    1. O’Connor AM. User manual: Decision Regret Scale. . Updated 2003. Accessed August 13, 2012.
    1. Brehaut JC, O’Connor AM, Wood TJ, et al. . Validation of a Decision Regret Scale. Med Decis Making. 2003;23(4):281-292. doi:10.1177/0272989X03256005
    1. Varni JW. The PedQL: measurement model for the Pediatric Quality of Life Inventory. . Published 2012. Accessed August 15, 2012.
    1. Schurman JV, Cushing CC, Garey CL, Laituri CA, St Peter SD. Quality of life assessment between laparoscopic appendectomy at presentation and interval appendectomy for perforated appendicitis with abscess: analysis of a prospective randomized trial. J Pediatr Surg. 2011;46(6):1121-1125. doi:10.1016/j.jpedsurg.2011.03.038
    1. Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003;3(6):329-341. doi:10.1367/1539-4409(2003)003<0329:TPAAPP>;2
    1. Varni JW, Limbers CA, Burwinkle TM. Parent proxy-report of their children’s health-related quality of life: an analysis of 13,878 parents’ reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007;5:2. doi:10.1186/1477-7525-5-2
    1. Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 Generic Core Scales in healthy and patient populations. Med Care. 2001;39(8):800-812. doi:10.1097/00005650-200108000-00006
    1. Fraenkel L, Rabidou N, Wittink D, Fried T. Improving informed decision-making for patients with knee pain. J Rheumatol. 2007;34(9):1894-1898.
    1. Zlowodzki M, Bhandari M. Outcome measures and implications for sample-size calculations. J Bone Joint Surg Am. 2009;91(suppl 3):35-40. doi:10.2106/JBJS.H.01602
    1. Mason RJ, Moazzez A, Sohn H, Katkhouda N. Meta-analysis of randomized trials comparing antibiotic therapy with appendectomy for acute uncomplicated (no abscess or phlegmon) appendicitis. Surg Infect (Larchmt). 2012;13(2):74-84. doi:10.1089/sur.2011.058
    1. Wiens BL, Dmitrienko A. The fallback procedure for evaluating a single family of hypotheses. J Biopharm Stat. 2005;15(6):929-942. doi:10.1080/10543400500265660
    1. Tsong Y, Zhang J. Simultaneous test for superiority and noninferiority hypotheses in active-controlled clinical trials. J Biopharm Stat. 2007;17(2):247-257. doi:10.1080/10543400601177434
    1. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies; 2001.
    1. Abeş M, Petik B, Kazil S. Nonoperative treatment of acute appendicitis in children. J Pediatr Surg. 2007;42(8):1439-1442. doi:10.1016/j.jpedsurg.2007.03.049
    1. Armstrong J, Merritt N, Jones S, Scott L, Bütter A. Non-operative management of early, acute appendicitis in children: is it safe and effective? J Pediatr Surg. 2014;49(5):782-785. doi:10.1016/j.jpedsurg.2014.02.071
    1. Eriksson S, Granström L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995;82(2):166-169. doi:10.1002/bjs.1800820207
    1. Georgiou R, Eaton S, Stanton MP, Pierro A, Hall NJ. Efficacy and safety of nonoperative treatment for acute appendicitis: a meta-analysis. Pediatrics. 2017;139(3):e20163003. doi:10.1542/peds.2016-3003
    1. Gorter RR, van der Lee JH, Cense HA, et al. ; APAC Study Group . Initial antibiotic treatment for acute simple appendicitis in children is safe: short-term results from a multicenter, prospective cohort study. Surgery. 2015;157(5):916-923. doi:10.1016/j.surg.2015.01.008
    1. Hansson J, Körner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009;96(5):473-481. doi:10.1002/bjs.6482
    1. Harnoss JC, Zelienka I, Probst P, et al. . Antibiotics versus surgical therapy for uncomplicated appendicitis: systematic review and meta-analysis of controlled trials. Ann Surg. 2017;265(5):889-900. doi:10.1097/SLA.0000000000002039
    1. Hartwich J, Luks FI, Watson-Smith D, et al. . Nonoperative treatment of acute appendicitis in children: a feasibility study. J Pediatr Surg. 2016;51(1):111-116. doi:10.1016/j.jpedsurg.2015.10.024
    1. Huang L, Yin Y, Yang L, Wang C, Li Y, Zhou Z. Comparison of antibiotic therapy and appendectomy for acute uncomplicated appendicitis in children: a meta-analysis. JAMA Pediatr. 2017;171(5):426-434. doi:10.1001/jamapediatrics.2017.0057
    1. Kaneko K, Tsuda M. Ultrasound-based decision making in the treatment of acute appendicitis in children. J Pediatr Surg. 2004;39(9):1316-1320. doi:10.1016/j.jpedsurg.2004.05.011
    1. Koike Y, Uchida K, Matsushita K, et al. . Intraluminal appendiceal fluid is a predictive factor for recurrent appendicitis after initial successful non-operative management of uncomplicated appendicitis in pediatric patients. J Pediatr Surg. 2014;49(7):1116-1121. doi:10.1016/j.jpedsurg.2014.01.003
    1. Mahida JB, Lodwick DL, Nacion KM, et al. . High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016;51(6):908-911. doi:10.1016/j.jpedsurg.2016.02.056
    1. Salminen P, Paajanen H, Rautio T, et al. . Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: the APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348. doi:10.1001/jama.2015.6154
    1. Salminen P, Tuominen R, Paajanen H, et al. . Five-year follow-up of antibiotic therapy for uncomplicated acute appendicitis in the APPAC randomized clinical trial. JAMA. 2018;320(12):1259-1265. doi:10.1001/jama.2018.13201
    1. Steiner Z, Buklan G, Stackievicz R, Gutermacher M, Erez I. A role for conservative antibiotic treatment in early appendicitis in children. J Pediatr Surg. 2015;50(9):1566-1568. doi:10.1016/j.jpedsurg.2015.04.008
    1. Styrud J, Eriksson S, Nilsson I, et al. . Appendectomy versus antibiotic treatment in acute appendicitis: a prospective multicenter randomized controlled trial. World J Surg. 2006;30(6):1033-1037. doi:10.1007/s00268-005-0304-6
    1. Svensson JF, Patkova B, Almström M, et al. . Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015;261(1):67-71. doi:10.1097/SLA.0000000000000835
    1. Tanaka Y, Uchida H, Kawashima H, et al. . Long-term outcomes of operative versus nonoperative treatment for uncomplicated appendicitis. J Pediatr Surg. 2015;50(11):1893-1897. doi:10.1016/j.jpedsurg.2015.07.008
    1. Turhan AN, Kapan S, Kütükçü E, Yiğitbaş H, Hatipoğlu S, Aygün E. Comparison of operative and non operative management of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2009;15(5):459-462.
    1. Vons C, Barry C, Maitre S, et al. . Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011;377(9777):1573-1579. doi:10.1016/S0140-6736(11)60410-8
    1. Hasday SJ, Chhabra KR, Dimick JB. Antibiotics vs surgery for acute appendicitis: toward a patient-centered treatment approach. JAMA Surg. 2016;151(2):107-108. doi:10.1001/jamasurg.2015.4065
    1. Livingston EH. Antibiotic treatment for uncomplicated appendicitis really works: results from 5 years of observation in the APPAC trial. JAMA. 2018;320(12):1245-1246. doi:10.1001/jama.2018.13368
    1. Telem DA. Shared decision making in uncomplicated appendicitis: it is time to include nonoperative management. JAMA. 2016;315(8):811-812. doi:10.1001/jama.2016.0168
    1. Stacey D, Bennett CL, Barry MJ, et al. . Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011;(10):CD001431.
    1. Anderson LA, Sharpe PA. Improving patient and provider communication: a synthesis and review of communication interventions. Patient Educ Couns. 1991;17(2):99-134. doi:10.1016/0738-3991(91)90014-V
    1. Harrington J, Noble LM, Newman SP. Improving patients’ communication with doctors: a systematic review of intervention studies. Patient Educ Couns. 2004;52(1):7-16. doi:10.1016/S0738-3991(03)00017-X
    1. Haywood K, Marshall S, Fitzpatrick R. Patient participation in the consultation process: a structured review of intervention strategies. Patient Educ Couns. 2006;63(1-2):12-23. doi:10.1016/j.pec.2005.10.005
    1. Post DM, Cegala DJ, Miser WF. The other half of the whole: teaching patients to communicate with physicians. Fam Med. 2002;34(5):344-352.
    1. Hibbard JH, Greene J, Becker ER, et al. . Racial/ethnic disparities and consumer activation in health. Health Aff (Millwood). 2008;27(5):1442-1453. doi:10.1377/hlthaff.27.5.1442

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit