'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention

Douglas J Opel, Jeffrey D Robinson, Heather Spielvogle, Christine Spina, Kathleen Garrett, Amanda F Dempsey, Cathryn Perreira, Miriam Dickinson, Chuan Zhou, Barbara Pahud, James A Taylor, Sean T O'Leary, Douglas J Opel, Jeffrey D Robinson, Heather Spielvogle, Christine Spina, Kathleen Garrett, Amanda F Dempsey, Cathryn Perreira, Miriam Dickinson, Chuan Zhou, Barbara Pahud, James A Taylor, Sean T O'Leary

Abstract

Introduction: A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.

Methods and analysis: We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.

Ethics and dissemination: This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.

Trial registration number: NCT03885232.

Keywords: community child health; paediatrics; public health.

Conflict of interest statement

Competing interests: AD and BP serve on advisory boards for Merck, Pfizer and Sanofi Pasteur, and have provided consulting services to Pfizer. BP’s institution receives research funding from GSK and Pfizer.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Difficulty by motivation matrix. PIVOT with MI, Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing; VHP, vaccine-hesitant parent.

References

    1. Centers for Disease Control and Prevention A CDC framework for preventing infectious diseases: sustaining the essentials and Innovating for the future, 2011.
    1. World Health Organization Ten threats to global health in 2019. Available: [Accessed 9 Oct 2019].
    1. Glanz JM, McClure DL, O'Leary ST, et al. . Parental decline of pneumococcal vaccination and risk of pneumococcal related disease in children. Vaccine 2011;29:994–9. 10.1016/j.vaccine.2010.11.085
    1. Glanz JM, McClure DL, Magid DJ, et al. . Parental refusal of varicella vaccination and the associated risk of varicella infection in children. Arch Pediatr Adolesc Med 2010;164:66–70. 10.1001/archpediatrics.2009.244
    1. Glanz JM, McClure DL, Magid DJ, et al. . Parental refusal of pertussis vaccination is associated with an increased risk of pertussis infection in children. Pediatrics 2009;123:1446–51. 10.1542/peds.2008-2150
    1. Glanz JM, Newcomer SR, Narwaney KJ, et al. . A population-based cohort study of undervaccination in 8 managed care organizations across the United States. JAMA Pediatr 2013;167:274–81. 10.1001/jamapediatrics.2013.502
    1. Assessing the state of vaccine confidence in the United States: recommendations from the National vaccine Advisory Committee: Approved by the National vaccine Advisory Committee on June 9, 2015 [corrected]. Public Health Rep 2015;130:573–95. 10.1177/003335491513000606
    1. Hammer LD, Curry ES, Harlor AD, et al. . Increasing immunization coverage. Pediatrics 2010;125:1295–304. 10.1542/peds.2010-0743
    1. Omer SB, Salmon DA, Orenstein WA, et al. . Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. N Engl J Med 2009;360:1981–8. 10.1056/NEJMsa0806477
    1. Benin AL, Wisler-Scher DJ, Colson E, et al. . Qualitative analysis of mothers' decision-making about vaccines for infants: the importance of trust. Pediatrics 2006;117:1532–41. 10.1542/peds.2005-1728
    1. Gust D, Brown C, Sheedy K, et al. . Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. Am J Health Behav 2005;29:81–92. 10.5993/AJHB.29.1.7
    1. Smith PJ, Kennedy AM, Wooten K, et al. . Association between health care providers' influence on parents who have concerns about vaccine safety and vaccination coverage. Pediatrics 2006;118:e1287–92. 10.1542/peds.2006-0923
    1. Gust DA, Darling N, Kennedy A, et al. . Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics 2008;122:718–25. 10.1542/peds.2007-0538
    1. Fredrickson DD, Davis TC, Arnould CL, et al. . Childhood immunization refusal: provider and parent perceptions. Fam Med 2004;36:431–9.
    1. McCauley MM, Kennedy A, Basket M, et al. . Exploring the choice to refuse or delay vaccines: a national survey of parents of 6- through 23-month-olds. Acad Pediatr 2012;12:375–83. 10.1016/j.acap.2012.06.007
    1. Daley MF, Crane LA, Chandramouli V, et al. . Influenza among healthy young children: changes in parental attitudes and predictors of immunization during the 2003 to 2004 influenza season. Pediatrics 2006;117:e268–77. 10.1542/peds.2005-1752
    1. Flood EM, Rousculp MD, Ryan KJ, et al. . Parents' decision-making regarding vaccinating their children against influenza: a web-based survey. Clin Ther 2010;32:1448–67. 10.1016/j.clinthera.2010.06.020
    1. Gnanasekaran SK, Finkelstein JA, Hohman K, et al. . Parental perspectives on influenza vaccination among children with asthma. Public Health Rep 2006;121:181–8. 10.1177/003335490612100213
    1. Nowalk MP, Lin CJ, Zimmerman RK, et al. . Changes in parents' perceptions of infant influenza vaccination over two years. J Natl Med Assoc 2007;99:636–41.
    1. Brewer NT, Gottlieb SL, Reiter PL, et al. . Longitudinal predictors of human papillomavirus vaccine initiation among adolescent girls in a high-risk geographic area. Sex Transm Dis 2011;38:197–204. 10.1097/OLQ.0b013e3181f12dbf
    1. Guerry SL, De Rosa CJ, Markowitz LE, et al. . Human papillomavirus vaccine initiation among adolescent girls in high-risk communities. Vaccine 2011;29:2235–41. 10.1016/j.vaccine.2011.01.052
    1. Smith PJ, Stokley S, Bednarczyk RA, et al. . HPV vaccination coverage of teen girls: the influence of health care providers. Vaccine 2016;34:1604–10. 10.1016/j.vaccine.2016.01.061
    1. Freeman VA, Freed GL. Parental knowledge, attitudes, and demand regarding a vaccine to prevent varicella. Am J Prev Med 1999;17:153–5. 10.1016/S0749-3797(99)00063-X
    1. Rosenthal SL, Kottenhahn RK, Biro FM, et al. . Hepatitis B vaccine acceptance among adolescents and their parents. J Adolesc Health 1995;17:248–54. 10.1016/1054-139X(95)00164-N
    1. Ylitalo KR, Lee H, Mehta NK. Health care provider recommendation, human papillomavirus vaccination, and race/ethnicity in the US national immunization survey. Am J Public Health 2013;103:164–9. 10.2105/AJPH.2011.300600
    1. Opel DJ, Heritage J, Taylor JA, et al. . The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics 2013;132:1037–46. 10.1542/peds.2013-2037
    1. Opel DJ, Mangione-Smith R, Robinson JD, et al. . The influence of provider communication behaviors on parental vaccine acceptance and visit experience. Am J Public Health 2015;105:1998–2004. 10.2105/AJPH.2014.302425
    1. Brewer NT, Hall ME, Malo TL, et al. . Announcements versus conversations to improve HPV vaccination coverage: a randomized trial. Pediatrics 2017;139. 10.1542/peds.2016-1764. [Epub ahead of print: 05 Dec 2016].
    1. Henrikson NB, Opel DJ, Grothaus L, et al. . Physician communication training and parental vaccine Hesitancy: a randomized trial. Pediatrics 2015;136:70–9. 10.1542/peds.2014-3199
    1. Miller WR. Motivational interviewing: research, practice, and puzzles. Addict Behav 1996;21:835–42. 10.1016/0306-4603(96)00044-5
    1. Motivational Interview Motivational interviewing. Available: [Accessed 01 Feb 2013].
    1. Berg CJ, Thomas JL, An LC, et al. . Change in smoking, diet, and walking for exercise in blacks. Health Educ Behav 2012;39:191–7. 10.1177/1090198111432252
    1. Brand VS, Bray KK, MacNeill S, et al. . Impact of single-session motivational interviewing on clinical outcomes following periodontal maintenance therapy. Int J Dent Hyg 2013;11:134–41. 10.1111/idh.12012
    1. Cooper L. Combined motivational interviewing and cognitive-behavioral therapy with older adult drug and alcohol abusers. Health Soc Work 2012;37:173–9. 10.1093/hsw/hls023
    1. Leask J, Kinnersley P, Jackson C, et al. . Communicating with parents about vaccination: a framework for health professionals. BMC Pediatr 2012;12:154. 10.1186/1471-2431-12-154
    1. McCain J. To heal the body, get into the patient's head: motivational interviewing: to improve adherence. Biotechnol Healthc 2012;9:10–12.
    1. Thomas ML, Elliott JE, Rao SM, et al. . A randomized, clinical trial of education or motivational-interviewing-based coaching compared to usual care to improve cancer pain management. Oncol Nurs Forum 2012;39:39–49. 10.1188/12.ONF.39-49
    1. Boutin-Foster C, Scott E, Rodriguez A, et al. . The trial using motivational interviewing and positive affect and Self-Affirmation in African-Americans with hypertension (triumph): from theory to clinical trial implementation. Contemp Clin Trials 2013;35:8–14. 10.1016/j.cct.2013.02.002
    1. Gabbay RA, Añel-Tiangco RM, Dellasega C, et al. . Diabetes nurse case management and motivational interviewing for change (dynamic): results of a 2-year randomized controlled pragmatic trial. J Diabetes 2013;5:349–57. 10.1111/1753-0407.12030
    1. Gance-Cleveland B. Motivational interviewing for adolescent obesity. Am J Nurs 2013;113:11. 10.1097/01.NAJ.0000425726.07495.ff
    1. Hides L, Carroll S, Scott R, et al. . Quik fix: a randomized controlled trial of an enhanced brief motivational interviewing intervention for alcohol/cannabis and psychological distress in young people. Psychother Psychosom 2013;82:122–4. 10.1159/000341921
    1. Klimas J, Field C-A, Cullen W, et al. . Psychosocial interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users: cochrane review. Syst Rev 2013;2:3. 10.1186/2046-4053-2-3
    1. Nirenberg T, Baird J, Longabaugh R, et al. . Motivational counseling reduces future police charges in court referred youth. Accid Anal Prev 2013;53:89–99. 10.1016/j.aap.2013.01.006
    1. Rongkavilit C, Naar-King S, Wang B, et al. . Motivational interviewing targeting risk behaviors for youth living with HIV in Thailand. AIDS Behav 2013;17:2063–74. 10.1007/s10461-013-0407-2
    1. Schoonheim-Klein M, Gresnigt C, van der Velden U. Influence of dental education in motivational interviewing on the efficacy of interventions for smoking cessation. Eur J Dent Educ 2013;17:e28–33. 10.1111/j.1600-0579.2012.00755.x
    1. Ski CF, Thompson DR. Motivational interviewing as a brief intervention to improve cardiovascular health. Eur J Cardiovasc Nurs 2013;12:226–9. 10.1177/1474515112472271
    1. Tse MMY, Vong SKS, Tang SK. Motivational interviewing and exercise programme for community-dwelling older persons with chronic pain: a randomised controlled study. J Clin Nurs 2013;22:1843–56. 10.1111/j.1365-2702.2012.04317.x
    1. Dempsey AF, Pyrznawoski J, Lockhart S, et al. . Effect of a health care professional communication training intervention on adolescent human papillomavirus vaccination: a cluster randomized clinical trial. JAMA Pediatr 2018;172:e180016. 10.1001/jamapediatrics.2018.0016
    1. Resnicow K, Teixeira PJ, Williams GC. Efficient allocation of public health and behavior change resources: the “difficulty by motivation” matrix. Am J Public Health 2017;107:55–7. 10.2105/AJPH.2016.303526
    1. Seither R, Calhoun K, Mellerson J, et al. . Vaccination coverage among children in kindergarten - United States, 2015-16 School Year. MMWR Morb Mortal Wkly Rep 2016;65:1057–64. 10.15585/mmwr.mm6539a3
    1. Sadaf A, Richards JL, Glanz J, et al. . A systematic review of interventions for reducing parental vaccine refusal and vaccine hesitancy. Vaccine 2013;31:4293–304. 10.1016/j.vaccine.2013.07.013
    1. Leask J. Target the fence-sitters. Nature 2011;473:443–5. 10.1038/473443a
    1. Opel DJ, Mangione-Smith R, Taylor JA, et al. . Development of a survey to identify vaccine-hesitant parents: the parent attitudes about childhood vaccines survey. Hum Vaccin 2011;7:419–25. 10.4161/hv.7.4.14120
    1. Opel DJ, Taylor JA, Mangione-Smith R, et al. . Validity and reliability of a survey to identify vaccine-hesitant parents. Vaccine 2011;29:6598–605. 10.1016/j.vaccine.2011.06.115
    1. Opel DJ, Taylor JA, Zhou C, et al. . The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr 2013;167:1065–71. 10.1001/jamapediatrics.2013.2483
    1. Glynn RJ, Brookhart MA, Stedman M, et al. . Design of cluster-randomized trials of quality improvement interventions aimed at medical care providers. Med Care 2007;45:S38–43. 10.1097/MLR.0b013e318070c0a0
    1. Raab GM, Butcher I. Balance in cluster randomized trials. Stat Med 2001;20:351–65. 10.1002/1097-0258(20010215)20:3<351::AID-SIM797>;2-C
    1. Kraschnewski JL, Keyserling TC, Bangdiwala SI, et al. . Optimized probability sampling of study sites to improve generalizability in a multisite intervention trial. Prev Chronic Dis 2010;7:A10.
    1. Chaudhary MA, Moulton LH. A SAS macro for constrained randomization of group-randomized designs. Comput Methods Programs Biomed 2006;83:205–10. 10.1016/j.cmpb.2006.04.011
    1. Dickinson LM, Beaty B, Fox C, et al. . Pragmatic cluster randomized trials using covariate constrained randomization: a method for practice-based research networks (PBRNs). J Am Board Fam Med 2015;28:663–72. 10.3122/jabfm.2015.05.150001
    1. Committee on Infectious Diseases, American Academy of Pediatrics Recommended childhood and adolescent immunization schedule--United States, 2014. Pediatrics 2014;133:357–63. 10.1542/peds.2013-3965
    1. Davis DA, Thomson MA, Oxman AD, et al. . Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA 1995;274:700–5. 10.1001/jama.274.9.700
    1. Grimshaw JM, Shirran L, Thomas R, et al. . Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001;39:II2–45.
    1. Bauchner H, Simpson L, Chessare J. Changing physician behaviour. Arch Dis Child 2001;84:459–62. 10.1136/adc.84.6.459
    1. Merriam SB, Cafrrarella RS. Learing in adulthood. San Francisco, CA: Jossey-Bass, 2008.
    1. Bero LA, Grilli R, Grimshaw JM, et al. . Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane effective practice and organization of care review group. BMJ 1998;317:465–8. 10.1136/bmj.317.7156.465
    1. Grimshaw JM, Eccles MP, Walker AE, et al. . Changing physicians' behavior: what works and thoughts on getting more things to work. J Contin Educ Health Prof 2002;22:237–43. 10.1002/chp.1340220408
    1. O'Brien MA, Rogers S, Jamtvedt G, et al. . Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2007;308:CD000409 10.1002/14651858.CD000409.pub2
    1. Rao JK, Anderson LA, Inui TS, et al. . Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care 2007;45:340–9. 10.1097/01.mlr.0000254516.04961.d5
    1. Ivers N, Jamtvedt G, Flottorp S, et al. . Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012;154:CD000259. 10.1002/14651858.CD000259.pub3
    1. Dearing JW. Applying diffusion of innovation theory to intervention development. Res Soc Work Pract 2009;19:503–18. 10.1177/1049731509335569
    1. Davidson EM, Liu JJ, Bhopal R, et al. . Behavior change interventions to improve the health of racial and ethnic minority populations: a tool kit of adaptation approaches. Milbank Q 2013;91:811–51. 10.1111/1468-0009.12034
    1. Netto G, Bhopal R, Lederle N, et al. . How can health promotion interventions be adapted for minority ethnic communities? five principles for guiding the development of behavioural interventions. Health Promot Int 2010;25:248–57. 10.1093/heapro/daq012
    1. Luman ET, Barker LE, Shaw KM, et al. . Timeliness of childhood vaccinations in the United States: days undervaccinated and number of vaccines delayed. JAMA 2005;293:1204–11. 10.1001/jama.293.10.1204
    1. Centers for Disease Control and Prevention (CDC) Progress in immunization information systems - United States, 2012. MMWR Morb Mortal Wkly Rep 2013;62:1005–8.
    1. Jackson ML, Henrikson NB, Grossman DC. Evaluating Washington state's immunization information system as a research tool. Acad Pediatr 2014;14:71–6. 10.1016/j.acap.2013.10.002
    1. Heritage J, Maynard DW. Communication in medical care : interaction between primary care physicians and patients. 1 edn New York: Cambridge University Pres, 2006.
    1. Rubin HR, Gandek B, Rogers WH, et al. . Patients' ratings of outpatient visits in different practice settings. results from the medical outcomes study. JAMA 1993;270:835–40.
    1. Wissow LS, Roter D, Bauman LJ, et al. . Patient-provider communication during the emergency department care of children with asthma. The National cooperative inner-city asthma study, National Institute of allergy and infectious diseases, NIH, Bethesda, MD. Med Care 1998;36:1439–50. 10.1097/00005650-199810000-00002
    1. Bean-Mayberry BA, Chang C-CH, McNeil MA, et al. . Patient satisfaction in women's clinics versus traditional primary care clinics in the Veterans administration. J Gen Intern Med 2003;18:175–81. 10.1046/j.1525-1497.2003.20512.x
    1. Tom JO, Mangione-Smith R, Solomon C, et al. . Integrated personal health record use: association with parent-reported care experiences. Pediatrics 2012;130:e183–90. 10.1542/peds.2011-1786
    1. American Institutes of Research on behalf of the Robert Wood Johnson Foundation How to report results of the CAHPS clinician & group survey, 2010. Available: [Accessed 7 Nov 2013].
    1. Hays RD. The outpatient satisfaction questionnaire (OSQ-37): executive summary. Santa Monica, CA: RAND, 1995.
    1. Stewart MA. What is a successful doctor-patient interview? A study of interactions and outcomes. Soc Sci Med 1984;19:167–75. 10.1016/0277-9536(84)90284-3
    1. Yancy WS, Macpherson DS, Hanusa BH, et al. . Patient satisfaction in resident and attending ambulatory care clinics. J Gen Intern Med 2001;16:755–62. 10.1111/j.1525-1497.2001.91005.x
    1. Little RJA. A test of missing completely at random for multivariate data with missing values. J Am Stat Assoc 1988;83:1198–202. 10.1080/01621459.1988.10478722

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