Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians.

Delay or refusal of childhood vaccines is common and may be increasing. Pediatricians are parents' most trusted source for vaccine information, yet many struggle with how to communicate with parents who resist recommended vaccines. Evidence-based communication strategies for vaccine conversations are lacking. In this manuscript, we describe the development and perceived usefulness of a curriculum to train clinicians on a specific vaccine communication strategy as part of the PIVOT with MI study, a cluster randomized trial testing the effectiveness of this communication strategy on increasing childhood vaccination uptake among 24 pediatric practices in Colorado and Washington. The communication strategy is based on the existing evidence-based communication strategies of a presumptive format for initiating vaccine conversations and use of motivational interviewing if hesitancy persists. Focus groups and semi-structured interviews with pediatric clinicians helped inform the development of the training curriculum, which consisted of an introductory video module followed by 3 training sessions. Between September 2019 and January 2021, 134 pediatric clinicians (92 pediatricians, 42 advanced practice providers) participated in the training as part of the PIVOT with MI study. Of these, 92 % viewed an introductory video module, 93 % attended or viewed a baseline synchronous training, 82 % attended or viewed a 1st refresher training, and 77 % attended or viewed a 2nd refresher training. A follow-up survey was administered August 2020 through March 2021; among respondents (n = 100), >95 % of participants reported that each component of the training program was very or somewhat useful. These data suggest that the PIVOT with MI training intervention is a useful vaccine communication resource with the potential for high engagement among pediatric clinicians.

"It's Like 1998 Again": Why Parents Still Refuse and Delay Vaccines.

We conducted a qualitative study from 2018 to 2019 to update the reasons why US parents' refuse or delay vaccines. Four focus groups and 4 semi-structured interviews involving 33 primary care pediatric providers were conducted in Washington and Colorado. A thematic analysis was conducted to identify themes related to reasons for parental refusal or delay. Five predominant themes were identified: (1) vaccine safety, (2) relative influence of information sources, decision-makers, and timing, (3) low perceived risk of contracting vaccine-preventable disease, (4) lack of trust, and (5) religious objection. Vaccine safety was the theme mentioned most frequently by providers (N = 45 times by 26 providers) and religious objection to vaccination was referred to the least (N = 6 times by 6 providers). Provider-reported reasons for parental refusal or delay of childhood vaccines in 2018 to 2019 remain similar to those reported in previous studies.

Motivational Interviewing for Maternal Immunisation (MI4MI) study: a protocol for an implementation study of a clinician vaccine communication intervention for prenatal care settings.

INTRODUCTION: Vaccination against influenza and pertussis in pregnancy offers a 'two-for-one' opportunity to protect mother and child. Pregnant patients have increased risk of severe disease from influenza and newborns have increased risk of severe disease from both influenza and pertussis. Obstetricians need communication tools to support their self-efficacy and effectiveness in communicating the importance of immunisation during pregnancy and ultimately improving maternal vaccination rates. METHODS AND ANALYSIS: We describe the protocol for a pragmatic study testing the feasibility and potential impact of a clinician communication strategy on maternal vaccination uptake. This study will be conducted in five prenatal care settings in Colorado, USA. The Motivational Interviewing for Maternal Immunisation strategy involves training prenatal care providers to use motivational interviewing in the vaccine conversation with pregnant patients. Our primary outcomes will be the adoption and implementation of the intervention measured using the Enhanced RE-AIM/Practical Robust Implementation and Sustainability Model for dissemination and implementation. Secondary outcomes will include provider time spent, fidelity to Motivational Interviewing and self-efficacy measured through audio recorded visits and provider surveys, patients' visit experience based on audio recorded visits and follow-up interviews, and maternal vaccine uptake as measured through chart reviews. ETHICS AND DISSEMINATION: This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION NUMBER: NCT04302675.

'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.

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.

Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study.

PURPOSE: The aim of the current study was to increase the uptake of screening mammography among high-risk women who were treated for a childhood cancer with chest radiotherapy. PATIENTS AND METHODS: Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months were randomly assigned 2:1 to receive a mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control. Primary outcome was the difference in the proportion of participants who completed a screening mammogram by 12 months as evaluated in an intent-to-treat analysis. Stratum-adjusted relative risk (RR) and 95% CI were estimated using the Cochran-Mantel-Haenszel method. Secondary outcomes included the completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors. RESULTS: Women in the intervention group were significantly more likely than those in the control group to report a mammogram (45 [33.1%] of 136 v 12 [17.6%] of 68; RR, 1.9; 95% CI, 1.1 to 3.3). The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2). The proportion of women who reported a breast MRI at 12 months was similar between the two groups: 16.2% (intervention) compared with 13.2% (control; RR, 1.2; 95% CI, 0.6 to 2.5). Primary barriers to completing a screening mammogram and/or breast MRI included lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms. CONCLUSION: Use of mailed materials followed by telephone-delivered counseling increased mammography screening rates in survivors at high risk for breast cancer; however, this approach did not increase the rate of breast MRI. Cost of imaging and physician recommendation were important barriers that should be addressed in future studies.

Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial.

Importance: The incidence of human papillomavirus (HPV)-related cancers is more than 35 000 cases in the United States each year. Effective HPV vaccines have been available in the United States for several years but are underused among adolescents, the target population for vaccination. Interventions to increase uptake are needed. Objective: To evaluate the effect of a 5-component health care professional HPV vaccine communication intervention on adolescent HPV vaccination. Design, Setting, and Participants: A cluster randomized clinical trial using covariate-constrained randomization to assign study arms and an intent-to-treat protocol was conducted in 16 primary care practices in the Denver, Colorado, metropolitan area. Participants included 188 medical professionals and 43 132 adolescents. Interventions: The 5 components of the intervention were an HPV fact sheet library to create customized information sheets relevant to each practice's patient population, a tailored parent education website, a set of HPV-related disease images, an HPV vaccine decision aid, and 2½ hours of communication training on using a presumptive vaccine recommendation, followed by motivational interviewing if parents were resistant to vaccination. Each practice participated in a series of 2 intervention development meetings over a 6-month period (August 1, 2014, to January 31, 2015) before the intervention. Main Outcomes and Measures: Differences between control and intervention changes over time (ie, difference in differences between the baseline and intervention period cohorts of patients) in HPV vaccine series initiation (≥1 dose) and completion (≥3 doses) among patients aged 11 to 17 years seen at the practices between February 1, 2015, and January 31, 2016. Vaccination data were obtained from the practices' records and augmented with state immunization information system data. Results: Sixteen practices and 43 132 patients (50.3% female; median age, 12.6 years [interquartile range, 10.8-14.7 years] at the beginning of the study period) participated in this trial. Adolescents in the intervention practices had significantly higher odds of HPV vaccine series initiation (adjusted odds ratio [aOR], 1.46; 95% CI, 1.31-1.62) and completion (aOR, 1.56; 95% CI, 1.27-1.92) than those in the control practices (a 9.5-absolute percentage point increase in HPV vaccine series initiation and a 4.4-absolute percentage point increase in HPV vaccine series completion in intervention practices). The intervention had a greater effect in pediatric practices compared with family medicine practices and in private practices compared with public ones. Health care professionals reported that communication training and the fact sheets were the most used and useful intervention components. Conclusions and Relevance: A health care professional communication intervention significantly improved HPV vaccine series initiation and completion among adolescent patients. Trial Registration: clinicaltrials.gov Identifier: NCT02456077.

Improving Provider Communication about HPV Vaccines for Vaccine-Hesitant Parents Through the Use of Motivational Interviewing.

Human papillomavirus (HPV) vaccine uptake is below that of other routine adolescent vaccines. This is due in part to the fact that the HPV vaccine is often not routinely recommended by providers to all eligible adolescents. While providers' recommendations are crucial, even a strongly stated recommendation can be insufficient among HPV vaccine-hesitant parents. Providers must be prepared to respond to parental concerns following giving the recommendation for the HPV vaccine. This paper presents the analysis of implementation of an intervention aimed at improving provider communication with HPV vaccine-hesitant parents. Healthcare providers and staff at eight pediatric and family medicine clinics received communication training that included motivational interviewing (MI) techniques. Process evaluation in the form of serial surveys, as well as program evaluation in the form of focus groups with participating providers and staff, assessed the perceived efficacy of the intervention. Outcomes included time spent discussing the HPV vaccine during clinical visits, providers' self-efficacy for addressing parental HPV vaccine hesitancy, and their general perceptions of the effectiveness of MI techniques. Overall, findings indicate the intervention improved providers' communication with HPV vaccine-hesitant parents and providers reported the use of MI played a central role in improved HPV vaccine acceptance. Lessons learned and recommendations for future interventions are also discussed.

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers.

BACKGROUND: A majority of continuing smokers in the United States are socioeconomically disadvantaged (SED) adults, who are less likely than others to achieve and maintain abstinence despite comparable quit-attempt rates. A national research initiative seeks effective new strategies for increasing successful smoking cessation outcomes among SED populations. There is evidence that chronic and acute stressors may interfere with SED smokers who try to quit on their own. Patient navigators have been effectively used to improve adherence to chronic disease treatment. We designed and have pilot-tested an innovative, non-clinical community-based intervention--smoking cessation treatment navigators--to determine feasibility (acceptance, adherence, and uncontrolled results) for evaluation by randomized controlled trial (RCT). METHODS: The intervention was developed for smokers among parents and other household members of inner city pre-school for low-income children. Smoking cessation treatment navigators were trained and deployed to help participants choose and adhere to evidence-based cessation treatment (EBCT). Navigators provided empathy, resource-linking, problem-solving, and motivational reinforcement. Measures included rates of study follow-up completion, EBCT utilization, navigation participation, perceived intervention quality, 7-day point abstinence and longest abstinence at three months. Both complete-case and intent-to-treat analyses were performed. RESULTS: Eighty-five percent of study participants (n = 40) completed final data collection. More than half (53%) enrolled in a telephone quitline and nearly three-fourths (71%) initiated nicotine replacement therapy. Participants completed a mean 3.4 navigation sessions (mean 30 min duration) and gave the intervention very high quality and satisfaction ratings. Self-reported abstinence was comparable to rates for evidence-based cessation strategies (21% among study completers, 18% using intent-to-treat analysis; median 21 days abstinent among relapsers). CONCLUSIONS: The pilot results suggest that smoking cessation treatment navigators are feasible to study in community settings and are well-accepted for increasing use of EBCT among low-income smokers. Randomized controlled trial for efficacy is warranted.

A randomized trial to increase colonoscopy screening in members of high-risk families in the colorectal cancer family registry and cancer genetics network.

BACKGROUND: Individuals with a strong family history of colorectal cancer have significant risk for colorectal cancer, although adherence to colonoscopy screening in these groups remains low. This study assessed whether a tailored telephone counseling intervention can increase adherence to colonoscopy in members of high-risk families in a randomized, controlled trial. METHODS: Eligible participants were recruited from two national cancer registries if they had a first-degree relative with colorectal cancer under age 60 or multiple affected family members, which included families that met the Amsterdam criteria for hereditary non-polyposis colon cancer (HNPCC), and if they were due for colonoscopy within 24 months. Participants were randomized to receive a tailored telephone intervention grounded in behavioral theory or a mailed packet with general information about screening. Colonoscopy status was assessed through follow-up surveys and endoscopy reports. Cox proportional hazards models were used to assess intervention effect. RESULTS: Of the 632 participants (ages 25-80), 60% were female, the majority were White, non-Hispanic, educated, and had health insurance. Colonoscopy adherence increased 11 percentage points in the tailored telephone intervention group, compared with no significant change in the mailed group. The telephone intervention was associated with a 32% increase in screening adherence compared with the mailed intervention (HR, 1.32; P = 0.01). CONCLUSIONS: A tailored telephone intervention can effectively increase colonoscopy adherence in high-risk persons. This intervention has the potential for broad dissemination to healthcare organizations or other high-risk populations. IMPACT: Increasing adherence to colonoscopy among persons with increased colorectal cancer risk could effectively reduce incidence and mortality from this disease.

Escitalopram-associated acute urinary retention.

New-onset urinary retention can typically be explained by the use of the routine normally suspected medications (e.g., anticholinergics, antihistamines). However, selective serotonin-reuptake inhibitors are not typically presumed as the cause of acute urinary retention (AUR). The following case describes the introduction of escitalopram in a patient and the subsequent development of AUR. Medical causes of urinary retention had been ruled out, and ipratropium was initially suspected to be the cause of urinary difficulties and was discontinued. However, the retention persisted four days after suspending the ipratropium. Normal micturition resumed only after stopping the escitalopram without further need for catheterization. Escitalopram may cause rare cases of AUR and may often times be overlooked possibly because of the paucity of reporting.

Bridging the transition from cancer patient to survivor: pilot study results of the Cancer Survivor Telephone Education and Personal Support (C-STEPS) program.

OBJECTIVE: To develop a feasibility study of a theory-driven telephone counseling program to enhance psychosocial and physical well-being for cancer survivors after treatment. METHODS: Participants (n=66) were recruited from two Colorado hospitals with self-administered questionnaires at baseline and two weeks post-intervention. The one group, intervention only design included up to six thematic telephone counseling sessions over three months. Topics included nutrition, physical activity, stress management, and medical follow-up. Primary outcomes were cancer-specific distress, self-reported fruit and vegetable consumption and physical activity. RESULTS: Of 66 subjects, 46 completed at least one counseling module and the follow-up assessment (70% retention rate). Mean satisfaction was 9 out of 10, and all participants would recommend C-STEPS to other survivors. Cancer-specific distress (Impact of Event Scale - Intrusion subscale) decreased for entire study population (p<0.001) and stress management session participants (p<0.001). Fruit and vegetable consumption increased for nutrition and exercise session participants (p=0.02) and the entire sample (p=NS). Physical activity increased in the entire group (p=0.006) and for nutrition and exercise session participants (p=0.01). CONCLUSION AND PRACTICE IMPLICATIONS: C-STEPS is a feasible telephone counseling program that transcends geographic barriers, demonstrating the potential to decrease distress and promote coping and healthy lifestyles among cancer survivors.

The Family Health Promotion Project (FHPP): design and baseline data from a randomized trial to increase colonoscopy screening in high risk families.

Colorectal cancer (CRC) is a significant cause of mortality and morbidity in the United States, much of which could be prevented through adequate screening. Consensus guidelines recommend that high-risk groups initiate screening earlier with colonoscopy and more frequently than average risk persons. However, a large proportion of high risk individuals do not receive regular colonoscopic screening. The Family Health Promotion Project (FHPP) is a randomized-controlled trial to test the effectiveness of a telephone-based counseling intervention to increase adherence to risk-appropriate colonoscopy screening in high risk individuals. Unaffected members of CRC families from two national cancer family registries were enrolled (n=632) and randomized to receive either a single session telephone counseling intervention using Motivational Interviewing techniques or a minimal mail-out intervention. The primary endpoint, rate of colonoscopy screening, was assessed at 6, 12 and 24 months post-enrollment. In this paper, we describe the research design and telephone counseling intervention of the FHPP trial, and report baseline data obtained from the two high risk cohorts recruited into this trial. Results obtained at baseline confirm the need for interventions to promote colonoscopy screening among these high risk individuals, as well as highlighting several key opportunities for intervention, including increasing knowledge about risk-appropriate screening guidelines, and providing both tailored risk information and barriers counseling.

Can telephone counseling post-treatment improve psychosocial outcomes among early stage breast cancer survivors?

OBJECTIVE: To determine whether a telephone counseling program can improve psychosocial outcomes among breast cancer patients post-treatment. METHODS: A randomized trial was conducted involving 21 hospitals and medical centers, with assessments (self-administered questionnaires) at baseline, 12 and 18 months post-enrollment. Eligibility criteria included early stage diagnosis, enrollment during last treatment visit, and the ability to receive the intervention in English. Endpoints included distress (Impact of Event Scale), depression (Center for Epidemiologic Studies Depression Scale), and two study-specific measures: sexual dysfunction and personal growth. The control group (n=152) received a resource directory for breast cancer; the intervention group (n=152) also received a one-year, 16 session telephone counseling program augmented with additional print materials. RESULTS: Significant intervention effects were found for sexual dysfunction at 12 (p=0.03) and 18 months (p=0.04) and personal growth (12 months: p=0.005; 18 months: p=0.03). No differences by group were found in mean scores for distress and depression, with both groups showing significant improvement at 12 and 18 months (all p values for within-group change from baseline were

Telephone counseling in psychosocial oncology: a report from the Cancer Information and Counseling Line.

Providing psychosocial counseling services to cancer patients and their significant others by telephone is emerging as an alternative to traditional (in-person) counseling programs in psychooncology. In this paper, data are reported describing the clients of such a program that has been in continuous operation since 1981: the Cancer Information and Counseling Line (CICL) of the AMC Cancer Research Center. An examination of call record forms completed between 1 June 1998 and 30 May 1999 (N = 1627) revealed that the vast majority of callers were female (77%), non-Hispanic White (77%), with at least some college education (62%). Only 27% were cancer patients/survivors, compared to 43% who were spouses, other relatives and friends of cancer patients/survivors, and 16% who were symptomatic callers. Breast cancer was by far the most frequently mentioned cancer site (30%). Although initial topics of inquiry were dominated by requests for medical information (77%), with only a small percentage of callers initially requesting psychosocial support and counseling (12%), by the time, the call was completed, 67% had received some form of psychosocial support and/or counseling. Recommendations for future research are discussed within the context of this review.