Best Practice
OtherProvide vaccinations per usual care
Other names: standard of care, standard therapy
NCT Number: NCT06926062
This clinical trial compares usual care to interpersonal communication training and vaccination workflow training, alone or in combination, for improving communication about and recommendations for human papillomavirus (HPV) and other vaccinations in pharmacies. Low HPV vaccination in the United States has placed unvaccinated children at risk of developing cancers as adults that could have been prevented. Pharmacies can be convenient for vaccination because they are open longer hours, have shorter wait times, can see patients without appointments and may cost less. However, many people are not aware that vaccination is available in pharmacies and some pharmacies lack the commitment from staff to vaccinate or may not have protocols in place for vaccination. Proactive communication approaches to recommending HPV vaccination have been shown to be effective in medical offices but have not been tested in the pharmacy setting. Interpersonal communication training incorporates the 5 A's (assess, advice, agree, assist and arrange) behavioral counseling framework to strongly recommend HPV and other vaccines and effectively answer any questions or concerns about vaccination. Vaccination workflow training establishes vaccination decision support strategies that pharmacies use to improve vaccination workflows. Interpersonal communication training and vaccination workflow training alone or in combination may improve communication and recommendations for HPV vaccination and increase HPV vaccination in pharmacies.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Penn State University, University Park, Pennsylvania, United States
OUTLINE:
OBJECTIVE 1: Parents are randomized to receive messages on 1 of 6 topics.
TOPIC I (SAFETY AND SIDE EFFECTS): Parents review 4 messages on safety and side effects and complete a survey over 15-20 minutes in support of intervention refinement on study.
TOPIC II (VACCINE EFFECTIVENESS): Parents review 4 messages on vaccine effectiveness and complete a survey over 15-20 minutes in support of intervention refinement on study.
TOPIC III (SEXUAL ACTIVITY): Parents review 4 messages on sexual activity and complete a survey over 15-20 minutes in support of intervention refinement on study.
TOPIC IV (HPV VACCINE FOR BOYS): Parents review 4 messages on HPV vaccine for boys and complete a survey over 15-20 minutes in support of intervention refinement on study.
TOPIC V (AGE TO START VACCINE): Parents review 4 messages on age to start vaccine and complete a survey over 15-20 minutes in support of intervention refinement on study.
TOPIC VI (SCHOOL ENTRY REQUIREMENTS): Parents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study.
OBJECTIVE 2: Pharmacies are assigned to a strata of 4 pharmacies with similar characteristics and pharmacies within each strata are randomized to 1 of 4 groups.
GROUP I (CONTROL): Pharmacy staff provide vaccinations per usual care.
GROUP II (STRATEGY A): Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy.
GROUP III (STRATEGY B): Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy.
GROUP IV (STRATEGIES A AND B): Pharmacy staff receive interpersonal communication training as well as vaccination workflow training and provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provide vaccinations per usual care
Other names: standard of care, standard therapy
Review messages on safety and side effects
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Complete a survey
Receive interpersonal communication training
Provide vaccinations using the interpersonal communication strategy
Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was appropriate to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date
Appropriateness outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate appropriateness are sourced from evidence-based assessments of Intervention Appropriateness Measure (IAM) from Weiner et al. (2017). There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was appropriate in supporting HPV vaccination delivery to children ages 9-17.
Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date
Acceptability outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate acceptability are sourced from evidence-based assessments of Acceptability of Intervention Measure (AIM) from Weiner et al. (2017). There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17.
Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was feasible to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
Time frame: Up to completion of the 12 month trial period
Will conduct audits of the pharmacy electronic records to assess adherence to HPV vaccination protocols, by comparing the proportion of HPV vaccines given "on time" to children aged 9-10 and 11-12 versus "late" to children aged 13-17.
Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date
HPV vaccine delivery fidelity will be assessed via survey to parents following their child's HPV vaccination. Parents will be asked to indicate which of seven, if any, supportive vaccination behaviors occurred during their visit in a "select all that apply" format. The seven experiences correspond to vaccination behaviors that have been shown in formative research to support HPV vaccine delivery and parents' perceptions of acceptability and appropriateness of HPV vaccination workflows using the 5As Behavioral Counseling Model (Sturgiss et al. 2017). The supportive behaviors include eligibility screening, recommendation, counseling, documentation and record retrieval support, PCP reporting, and scheduling for follow up. To summarize the overall fidelity to the workflow per respondent, study researchers will create a composite "fidelity score" by summing the number of behaviors each parent endorsed (range: 0-7). Higher scores will indicate greater adherence to the recommended workflow.
Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Assessed via survey. The survey was developed by study researchers and includes validated measures from a 31-item medication therapy management (MTM) efficacy scale (Martin B, et al. 2010) and a statewide survey of healthcare providers (McRee AL, et.al. 2014). It will be used to capture change of participants' perceptions pre/post training. For this outcome there are five answers to each survey question reflecting how confident the respondent is in performing tasks related to providing HPV vaccinations to children, and each answer is given a score from 1 to 5, with 1 being not at all confident/strongly disagree and 5 being completely confident/strongly agree. Higher numerical scores on the 5-point scale reflect higher levels of self-efficacy or confidence in personal ability to complete vaccination process actions. Study researchers will calculate the average scale based on numeric scores.
Time frame: Up to 12 months post intervention delivery
Will be defined by pre and post changes in overall adolescent vaccine doses delivered across trial arms. Will present unadjusted and adjusted odds ratios accounting for multiple comparisons.
Time frame: Up to 12 months post intervention delivery
Will be defined by pre and post changes in each pharmacy's HPV and other vaccination rates across trial arms.
Time frame: Up to 12 months post intervention delivery
Will be defined as the total number and proportion of patients who received HPV vaccination by intervention arm, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster.
Time frame: Up to 24 months
Parents will be asked to identify differences between the vaccination experience at the pharmacy compared to their child's doctor's office. Example measures: "How would you rate your pharmacy's vaccination service compared to vaccination services at your child's doctor's office?"
Time frame: Up to 24 months
In qualitative interviews, pharmacy staff will be asked about internal factors that impacted the delivery and uptake of the intervention, Example measure: "How would you rate the implementation process planning with the study team?" (Pharmacy staff; construct: Planning)
Time frame: Up to 24 months
In a qualitative interview, pharmacy staff will be asked to rate the implementation process planning with the study team.
Time frame: Up to 24 months
Pharmacy staff will be asked to compare the intervention to usual practice. Example measures: "Using the communication strategy is a better approach for delivering HPV vaccination than what I usually do."
Time frame: Up to 24 months
Assessed via qualitative interviews with pharmacy staff. Example measures: "How confident are you with counseling patients on HPV vaccine?" (pharmacy staff; construct: Self-efficacy
Contact information is provided by the study sponsor or research team.
Kate Watabayashi
CONTACT
Morgan Glascock
CONTACT
Fred Hutchinson Cancer Center
Other
Implementing a Proactive Approach to Communicate and Teach About HPV Vaccination in Pharmacies: IMPACT HPV Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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