Cervical Cancer Clinical Trial
Official title:
HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts
Primary, Secondary, and Exploratory Objective(s):
Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV
vaccine.
Study Rationale:
Human papillomavirus (HPV) vaccine uptake among females and males remains unacceptably low.
Health care provider recommendation of HPV vaccine is a major driver of vaccine acceptance.
Conversely, the failure of health care providers to recommend HPV vaccine has repeatedly
been identified as the primary factor in non-vaccination. Among many recommendations for
increasing HPV vaccination rates are several that specifically target health care providers.
Two approaches are implementation of electronic health records-based decision support
systems and interventions designed to help physicians recommend HPV vaccine in a routine,
matter-of-fact manner that addresses uneasiness in discussing sexual activity with parents
of adolescents.
A randomized, 3-arm interventional study is proposed.
The 3 arms (randomized at the level of health care provider) will be:
1. usual practice;
2. automated reminders to recommend HPV vaccine for eligible male and female adolescents
during clinic visits;
3. automated reminders PLUS a suggested recommendation script.
Here is a draft of the recommendation script that the study team is proposing for the third
arm of the study: "Three vaccines are recommended for <first name>, meningococcal to prevent
meningitis, HPV to prevent cancer, and Tdap to prevent tetanus. All three are recommended at
this age". The script draft was based on the principles of Diffusion Theory and on theories
of learning and memory.
Diffusion Theory predicts that adoption of an innovation (in this case the recommendation
script) is predicted by three central factors:
1. The innovation should be seen as superior to the approach it is intended to replace
(ADVANTAGE);
2. The innovation should be viewed as consistent with pre-existing beliefs and experiences
(COMPATIBILITY); and
3. The innovation should be seen as easy to understand and implement (COMPLEXITY).
It is believed that the proposed script meets the ADVANTAGE criterion in that it provides a
simple, straightforward way of introducing the HPV vaccine into conversations with
adolescents and their parents, an issue with which some physicians struggle. The script
meets the COMPATIBILITY criterion in that it makes the HPV vaccine recommendation consistent
with the way other vaccines are typically recommended in conversations with adolescents and
their parents. Finally, the proposed script meets the COMPLEXITY criterion in that it is
simple and will likely be time-saving in most cases. Furthermore, the existing electronic
health record (EHR) infrastructure at the target clinics will support easy introduction of
the recommendation and script into clinical workflow.
Research in learning and memory has shown that information presented first or last in a
sequence has the greatest salience and is therefore most likely to be remembered. In our
suggested script, HPV vaccine was purposely in the middle, between Tdap and meningococcal
vaccines to decrease the salience of HPV vaccination, thereby helping physicians to treat
the three vaccines in a consistent manner. When HPV vaccine is mentioned last, there may be
a tendency to hesitate or to treat it as separate from the other recommended vaccines.
Approximately 30 pediatric health care providers will be randomized across the 3 arms in
equal numbers. The primary outcome of interest, HPV vaccination, will be evaluated as a
patient outcome nested within provider. Physician acceptance of the recommendations,
comparing changes in vaccination rates with qualitative feedback from providers will be
further assessed. To gather qualitative feedback, 3-4 pediatric health care providers in
each clinic will be interviewed. Participants will be purposely selected based on provider
demographics, including gender, years in practice, and role within the clinic organizational
structure. The interviews will be guided by the Consolidated Framework for Implementation
Research (CFIR), a theory and evidence-based framework that represents the accumulated
results of over 50 years of research on implementation and diffusion. Mixed methods will
enable the team to examine not only impact on vaccination rates but also the characteristics
of the reminder (e.g., usability, support of workflow), its implementation, and the context
of setting in which it was implemented (e.g., clinical structure).
Aims and Objectives Aim 1. To evaluate the effects of physician-targeted automated HPV
vaccination reminders alone and reminders plus a recommended script on HPV vaccination rates
among 9-12 year old male and female patients.
Hypothesis. It is expected that a linear increase in HPV vaccination rates across the usual
practice control group and the two intervention conditions, such that the reminder + script
group will have the highest first dose HPV vaccination rates, followed by the reminder-only
group will be noted.
Secondary objective: To evaluate rates of return for second dose. Exploratory objective: To
evaluate experiences of pediatric health care providers with the reminder and script
interventions.
Materials and Methods:
The Child Health Improvement through Computer Automation (CHICA) system, described in detail
above, has already been developed and has been in operation since November of 2004. The
functionality is well documented. New components of the system will have to be developed for
this study. The first of these will be the activation of CHICA's ability to randomize its
alerts by provider. The second will be the development of the Arden Syntax rules (Medical
Logic Modules) to query the data from the immunization registry and generate appropriate
prompts and reminders to the clinician. Once written, these rules must be encoded in CHICA
and extensively tested with clinical data before they are deployed. Third, the study team
will develop a mechanism by which CHICA can query the immunization registry at some time
point after the clinic visit to determine whether an HPV vaccine was administered.
Include potential difficulties and limitations of the available methods and strategies for
overcoming those methods. Randomization by physician depends on having accurate data from
the clinic's registration system about which physician the patient will see. The study team
has used this information in the past without significant problems. However, if it is noted
that the data are missing or unreliable in a significant number of cases, the study team can
ask for the information to be entered into the system by clinic personnel prior to the
visit.
Programming of Arden rules is part and parcel of operating the CHICA system. So the study
team does not anticipate problems with developing and testing these. The study team closely
monitor the display and response to CHICA reminders. If there is a problem, the study team
will be able to detect and correct it quickly.
The ability to query the CHIRP immunization registry by Health Level Seven International
(HL7) messaging has recently been developed. The responses from CHIRP are not perfect, but
are well over 90% reliable. The study team will build our system for querying CHIRP for HPV
data to track and reissue failed queries in order to maximize the available data.
The location of the study sites. As previously noted, the study will be conducted in the
five clinics in the Eskenazi Health System that currently use CHICA. They are: Eskenazi
Outpatient Care Center, Blackburn, Pecar, Eskenazi 38th St., and Forest Manor.
Outcome measurement. The outcome of primary interest, HPV vaccine uptake, will be recorded
by having the CHICA system re-query the CHIRP system after each visit. The study team will
record whether HPV vaccine was administered. The CHICA system will be programmed to track
patients who are enrolled in the study. Between 7 and 30 days after the clinic visit, CHICA
will send an HL7 query for vaccination (VXQ) message for each patient to the CHIRP
immunization registry of the Indiana State Department of Health. In response to this query
message, CHIRP will send an HL7 vaccination record response (VXR) message with the patient's
immunization record. Because all of the CHICA clinics report their immunization data to
CHIRP, this will be a reliable way to assess whether the patient received an HPV vaccine.
Predictors of HPV vaccine uptake. The study team will use the re-query of CHIRP to determine
which other vaccines (e.g., meningococcal; Tdap; influenza) were administered. Other
variables of interest that will be recorded will be provider seen, patient age, and patient
gender.
The 5 CHICA clinic study sites are located throughout metropolitan Indianapolis. These
clinics serve largely low income (70% Medicaid) and minority (33% Hispanic, 49% African
American) children. CHICA has provided data to over 37,000 children since first implemented
in 2004. As indicated in Part 1 (Introduction), these CHICA clinics have been used
successfully for multiple pediatric health service intervention studies. The real-world
implementation being used in this study is a great strength. It will enable us to evaluate
how a reminder system and recommended script influence HPV vaccination practices in busy
pediatric clinics. An inherent limitation with this kind of study is that the study team is
limited in the kind of data that can be collected. The study team cannot, for instance,
collect attitude/knowledge information from parents. However, it is believed that the
strengths of this research methodology far outweigh the limitations.
Qualitative interviews. Interviews will be digitally recorded and transcribed. Interviewers
will be asked to record field notes related to the interview to capture information not
included in the transcripts (e.g., tone of voice). Digital recordings will be transferred to
a password-protected computer, in a locked office. Recordings and transcripts will be saved
for a 3-year period from the end of the study. At that point in time, digital recordings and
transcripts will be permanently erased. Content analysis will enable investigators to
identify patterns in respondents' answers. The study team will specifically look for
barriers to implementation and use of the recommendations and scripts as well as contextual
aspects that facilitated routine use of the recommendations and scripts to improve adherence
to recommended HPV vaccination guidelines.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research
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