Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05006833 |
| Other study ID # |
IRB202001633 -N |
| Secondary ID |
R37CA234030 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 18, 2021 |
| Est. completion date |
August 28, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will test the effectiveness of two interventions (parent-targeted text messages
and a brief clinician-targeted training) at increasing HPV vaccination among 11- to
12-year-olds living in Florida.
Description:
Random Assignment: The study will test the hypotheses with a doubly randomized, two-level
nested design for testing two nested implementation factors. Randomization will occur at two
levels: the clinic and patient/parent. A group randomized trial forms the basis of
randomization.
The study will randomly assign a fixed number of 30 clinics (and the providers within each
clinic) equally to one of three provider trainings: (1) bundled training (n=10 clinics), (2)
benefits training (n=10 clinics), and (3) no training (n=10 clinics). All providers in each
clinic will be invited to participate in the assigned training. The investigators anticipate
an average of 2 providers per clinic. The study will stratify by baseline vaccination rates
to ensure balance across the three groups. The investigators chose to assign provider
trainings at the clinic level because it is more feasible to conduct one training at each
clinic and it limits the potential for contamination between providers.
The second level of randomization will occur among patients/parents. The investigators
anticipate between 70-100 adolescents per clinic. The study will randomly assign parents
(nested within clinic) equally to one of three text message groups: (1) bundled (n=30), (2)
benefits (n=30), and (3) no messages (n=30). Inclusion criteria are: 10 , 11 , and
12-year-olds, attended the clinic in the past two years, and do not have records of changing
providers or receiving the adolescent vaccines. Randomization will include 10-year-olds
because text messages will be sent just prior to the adolescents' 11th birthday. The study
will stratify text message assignment by patient biologic sex because of large differences in
HPV vaccination and possible differential effectiveness of text messages. To ensure
auditability, separate SAS programs will be written for the two levels of randomization.
Delivery of interventions: At each clinic randomized to training, providers will be invited
to participate in a group-based training occurring over Zoom. Each training will last
one-hour and providers will receive continuing medical education (CME) credit for
participating. Trainings will focus on increasing the providers' intention to recommend the
vaccine. Following best practices, each provider training will have a combination of
activities (presentation, concrete skills development, role-play, and feedback), will be
learner-centered, and engaging. Training will include: (A) presentation of HPV vaccination
background; (B) the approach explanation, script, and a video-recorded example of a provider
talking to a parent; (C) practicing prepared role play scenarios in small groups; and (D) an
explanation of the follow-up, audio-recorded trainings. For part B, the bundled training will
include existing nationally endorsed materials.
The study will audio-record thee visits with each provider to give individual feedback, to
offer boosters (e.g., script review or barrier discussions) to providers who are lower than
80% adherent, and to evaluate provider adherence to assigned approaches. To increase the
trialability, providers will be encouraged to use a standardized form to record their vaccine
recommendations with their next ten patients and compare the HPV vaccination rates to their
preceding ten patients.
For feasibility of scale-up and dissemination, text messages will be sent from clinics to
parents by integrating our message content and timing into the clinic's existing appointment
reminder system. The study will restrict recruitment to clinics with appointment reminder
systems. If integration is not feasible or preferable to a clinic, study staff will
facilitate texting.
Parents will be sent the interactive text messages as part of the clinics' quality
improvement efforts. Each clinic will send the text messages from their appointment reminder
phone number so parents are aware the messages are from the clinic. Parents who have
opted-out of clinic text messages or who did not provide the clinic with a text-enabled phone
number will be sent an email or automated voicemail message. Text messages will include an
opt-out option.
At the beginning of the study, text messages will be sent to the parents of all 11- to
12-year-olds who have attended each clinic within the past two years and do not have records
of changing providers or receiving the adolescent vaccines. Throughout the study year, we
will send a text message two weeks prior to the child's 11th birthday. Additional text
messages will be sent to parents of 11- to 12-year-olds who have a clinic appointment during
the study period at the same time as the texted appointment reminder. Parents who respond to
the text message will receive an appointment scheduling call within two business days.
Statistical analysis accounting for clustered design. Throughout the analysis, the
statistical team will be blinded to study arm assignments. Initially, descriptive statistics
(rates and means with 95% confidence intervals (CIs) will be compared between implementation
strategies (brief provider training and interactive text messages) and recommendation
approaches (bundled versus benefits).
To achieve all four study aims and evaluate the process measures, the study will account for
the clustered data with generalized linear mixed models (GLMMs; e.g., SAS PROC GLIMMIX)
rather than generalized estimating equations (GEE) given the relatively small number of
clusters (30 clinics) and the two levels of randomization. In all four aims, the primary
outcomes are HPV vaccination (initiation and up-to-date): binary variables at the patient
level. The GLMMs will assume a binomial distribution and use a log link, modeling risk (i.e.,
rates) of initiation and up-to-date and estimating rate ratios (RRs) between implementation
strategies and recommendation approaches. Staying within the framework of RR will aid
analysis of additive interactions (Aim 3). If convergence failure is an issue after exploring
avoidance methods, we will use the logit link and make interpretations around odds of
initiation and up-to-date.
Aims 1 and 2: Main Effects of Implementation Strategies on Outcomes. The study will test the
main effects of our implementation strategies on HPV vaccination rates with the inference of
the fixed effects. For inference on the fixed effects, we will use the between-within DDFM.
To account for the nested design, we will include random effects for provider and clinic.
Initially, the study will include a multiplicative interaction between provider training and
parent text messages to examine if one implementation strategy modifies the effect of the
other. If not significant (P>=0.05), as hypothesized, the investigators will remove the
multiplicative interaction and focus inference on the main effects (Aim 2) and additive
interactions (Aim 3). Given the stratified randomization, the investigators will adjust for
baseline HPV vaccination rates and patient sex. The investigators will also examine patient
sex and race/ethnicity as possible effect modifiers.
The secondary outcomes of interest are provider recommendation frequency (Aim 1) and patient
clinic visits (Aim 2). Clinic visits will be analyzed as binary (yes/no) with similar
modeling approaches described above. The study will also model number of clinic visits per
patient, most likely using a zero-inflated Poisson model (accounting for the clustered data
via random effects). The investigators will carefully examine the distribution of the
provider recommendation frequency, which is measured as a percentage of patient encounters
and will resemble continuous outcomes, to determine the appropriate distribution/link
function of the GLMM. The unit of analysis is provider, and therefore, only a random effect
of clinic is needed. For Aim 1, the investigators will also perform sensitivity analyses to
adjust for provider adherence score.
Aim 3: Additive Interaction of the Implementation Strategies. The investigators will
calculate the synergy index (S), which measures the extent to which the RR for concordant
provider and parent recommendation approaches together is greater than the sum of the
provider approach RR and parent approach RR (i.e., additive interaction). An S > 1 indicates
synergy and S < 1 indicates antagonism between the two approaches. Standard error
calculations for S will be estimated using standard software/modules based on the delta
method. S is a commonly-used measure of additive interaction of treatments/interventions. The
investigators will calculate this synergy to test the hypothesis associated with Aim 3.1
(testing the combined effectiveness of any provider and parent intervention), and the
investigators will calculate it separately for Aim 3.2 (testing the combined effectiveness of
concordant interventions).
Aim 4: Clinical Practice-Level Moderators of Implementation. To determine if the five
specified clinical practice factors modify the implementation strategies' effectiveness, we
will consider fixed effects for clinical practice factors on HPV vaccination, and assess the
specified interactions between clinical practice factors and the implementation strategies.
Process Evaluation Analysis Plan. The study will evaluate the effectiveness of the
implementation strategies on the process measures. For the provider training, the study will
evaluate changes in the primary targeted construct, provider intent to vaccinate, before,
immediately after, and a year after training. Mean levels of provider intent to vaccinate (a
composite of Likert-scaled questions) will be estimated and compared across the three time
points and across provider training arms via GLMMs as described above. For the interactive
text messages, the primary targeted construct of parent salience is measured in a one-time
survey of parents in all study arms. Parent salience rates will be estimated (with 95% CIs)
and compared across the parent text message arms using a similar modeling approach (with a
binary variable/logit link).
