Vouchers to Promote Tdap Vaccination

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Brief Title

Vouchers to Promote Tdap Vaccination

Official Title

Retail Pharmacy Vouchers to Promote Tdap Vaccination for Adults Living With Infants

Brief Summary

      This study is a small-scale randomized, placebo-controlled factorial trial of two
      interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization
      rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap
      voucher with or without an educational video.
    

Detailed Description

      The incidence of pertussis, a highly contagious respiratory illness, has more than tripled in
      the past five years, and is on track this year to be the most severe in over a half century.
      Pertussis is particularly dangerous, and commonly fatal, for young infants who have not
      completed the primary vaccination series. To protect infants, pregnant women and adult
      caregivers should receive Tdap vaccination, but coverage is estimated at only 10% for adult
      caregivers in close contact with infants.

      The objective of this study is to conduct a small-scale randomized controlled trial of an
      intervention to increase Tdap immunization rates among infant caregivers. The intervention is
      delivered at the newborn primary care visit and consists of two components: (1) Tdap vaccine
      vouchers redeemable at neighborhood retail pharmacies and (2) video-based education. The
      vouchers improve vaccine supply by reducing cost and improving accessibility of the vaccine,
      while the education component increases demand for the vaccine by making salient the dangers
      of pertussis and the importance adult vaccination to "cocoon" vulnerable infants. We will
      evaluate the feasibility and acceptability of each component or both compared to none and
      assess the impact on the vaccination of parents/caregivers of newborn infants.

      Recruitment for this pilot study will take place at a pediatric primary care practice site
      affiliated with a large children's hospital in Philadelphia, Pennsylvania (PA). The practice
      schedules approximately 135 newborn visits per month, typically at 2-14 days of life.
      Participants will redeem Tdap vaccine vouchers at 2 local Rite Aid pharmacies which are the
      closest Rite Aid locations to the clinic site. The pharmacy accepts all major insurance
      plans, although most plans (including Medicaid) do not cover Tdap vaccine delivered in
      pharmacies.

      All caregivers ≥ 18 years old who accompany an infant to a newborn visit will be approached
      by the study coordinator and details of the study will be explained. Caregivers will be asked
      to participate in the study and if interested, informed consent will be obtained before any
      study related procedures are performed. Potential subjects will then be screened using the
      protocol inclusion and exclusion criteria. The research assistant will utilize a data
      collection form to collect demographic data. After completion of the data collection form,
      participants will view an educational video if randomized to the education arm. After viewing
      the educational video, or after completion of data collection form for those who were not
      randomized to video, participants will receive an envelope containing the Tdap and baby care
      item voucher or gift card.

      Unvaccinated caregivers will receive an envelope containing 2 vouchers or a voucher and a
      gift card. The vouchers are: one for Tdap vaccination and one for a baby care item. Vouchers
      will be redeemable only at the two participating nearby Rite Aid pharmacies, will have no
      monetary value, and cannot be redeemed for any items other than the specified vaccine/baby
      care product.The gift card can be redeemed at any Rite Aid pharmacy.All envelopes will also
      contain the Center for Disease Control and Prevention (CDC) Vaccine Information Sheet (V.I.S)
      for the Tdap vaccine. Participants will be randomized to receive either: (1) a voucher for
      the full price of a Tdap vaccine ($63.99) + a baby care product voucher/or gift card, or (2)
      a voucher for $5 off a Tdap vaccine + a baby care product voucher/or gift card. The baby care
      product voucher / gift card will allow us to assess the proportion of respondents who make a
      trip to one of the pharmacies following the primary care visit and may also increase the
      probability that the study participants will visit one of the designated retail pharmacies.
      The full cost voucher removes any cost barriers related to the Tdap vaccine. The $5 voucher
      allows us to assess the effect of increased awareness, convenience, and accessibility on
      vaccine uptake, but without a significant price change. If two unvaccinated caregivers
      accompany an infant and both choose to enroll in the study, they may receive discordant Tdap
      voucher amounts; however, both will receive baby care product vouchers / gift cards.

      Randomization to each arm will occur through block randomization of study numbers that will
      take place prior to recruitment. The research assistants will show the video and will
      therefore not be blinded to educational arm. However, research assistants who enroll
      participants will be blinded to voucher arm as envelopes will be sealed. Research staff will
      enter the study number on the data collection form but only the principal investigator and
      study coordinator will have access to the master file indicating allocation to intervention
      group.

      Voucher redemption is voluntary; data regarding vaccination redemption will be collected by
      Rite Aid pharmacies. Participants who choose to redeem Tdap vaccine vouchers can do so, at
      their convenience, at 2 local Rite Aid pharmacies. At the pharmacy, the caregiver must
      complete a screening form before receiving Tdap. Vouchers are serialized with a barcode which
      is swiped at the time of redemption Baby care item vouchers will be like a coupon and can be
      redeemed by a cashier at the pharmacy.

      Project staff will perform phone follow-up interviews with participants one month after they
      were enrolled in the study to ascertain vaccination status and to solicit feedback on the
      intervention and barriers to vaccination.

      Baseline characteristics will be summarized by standard descriptive summaries (e.g. means and
      standard deviations for continuous variables and percentages for categorical variables). All
      vouchers will have unique identification (ID) numbers. Variables such as age, gender,
      insurance status, the relationship of the participant(s) to the infant, vaccination status,
      and the date and time of the voucher distribution will be summarized. The research
      coordinator will also record how many caregivers refuse to participate or are not approached
      for enrollment. The proportion of caregivers screened that meet enrollment criteria and the
      proportion meeting enrollment criteria that consent to participate will be calculated.

      We will measure the proportion of participants enrolled that redeemed a study Tdap voucher.
      In addition, we will assess the feasibility of voucher distribution, the completeness of
      redemption data recorded at the pharmacy, and the ability to assess caregiver vaccination
      status. Vaccination status will be determined by self-report at the time of enrollment and at
      the time of the follow-up interview. Vaccination rates will also be measured by Tdap voucher
      redemption. We will measure the redemption rate of the Tdap voucher by treatment arm ($5
      voucher vs. full-cost voucher, and video vs. no video), adjusting for sociodemographic
      characteristics. We will also determine the proportion of baby care product vouchers / gift
      cards redeemed by treatment arm.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Rate of Tdap Vaccination

Secondary Outcome

 Proportion of all vouchers that are redeemed

Condition

Whooping Cough

Intervention

Full price

Study Arms / Comparison Groups

 No Video: Full price & $5 off
Description:  Participants will not view the pertussis video

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

149

Start Date

July 2013

Completion Date

March 2015

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          1. All caregivers who report that they have never received Tdap

          2. Mothers who did not receive Tdap during their most recent pregnancy or since the birth
             of the child, even if she received Tdap during a previous pregnancy, as Tdap is now
             recommended for all pregnant women during each pregnancy.

          3. Previous receipt of a tetanus containing vaccine (i.e. Td or TT), regardless of the
             time interval since receipt of the tetanus-containing vaccine will be also eligible
             for the study.

          4. If a participant is certain they have not received Tdap within the past year but
             uncertain whether he/she has ever received Tdap, we will offer enrollment and
             encourage participants to obtain immunization records to confirm their status before
             voucher redemption. Rite Aid will follow their screening procedures which also
             includes assessing immunization status. Participants who do not know their Tdap
             vaccination status will receive the voucher intervention.

        Exclusion Criteria:

          1. Any adult caregiver who has previously received Tdap

          2. For recently-pregnant women: If a mother who received Tdap during her most recent
             pregnancy (2nd trimester or 3rd trimester) or since the birth of the child. Also, if
             the mother is unsure of her vaccination status and possibly received the vaccine
             during this pregnancy or in the last year
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kristen A Feemster, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01860378

Organization ID

13-010045


Responsible Party

Sponsor

Study Sponsor

Children's Hospital of Philadelphia

Collaborators

 Robert Wood Johnson Foundation

Study Sponsor

Kristen A Feemster, M.D., Principal Investigator, Children's Hospital of Philadelphia


Verification Date

April 2015