Case Example

Practice and apply the principles of pragmatic clinical trials


  • Read the background, context and study question of the case example
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  • Once you've completed the module, review your responses and compare them to the written debrief.

Background and Context

The following study is based on: Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart, Calonge N.  Population-Based Versus Recall for Childhood Immunizations: A Randomized Controlled Comparative Effectiveness Trial.  Am J Public Health 2013; 103:1116-1123. 

Vaccination is recognized as one of the greatest public health achievements of the 20th century.  Notably, incidence of major childhood infectious diseases has declined by 98% since childhood immunizations began.

However, only 68% of children aged 19-35 months receive all recommended vaccines in 2012.  A Healthy People 2020 goal is to increase the proportion of children aged 19-35 months who receive all recommended doses of childhood vaccines to 80%

The Community Preventive Services Task Force recommends the use of reminder/recall for increasing immunization rates.  Reminder/recall consists of: notification for upcoming immunizations (reminders) and recall notices for overdue immunizations (recall).

Practice-based reminder/recall has been proven efficacious in multiple RCTs; however, few providers are conducting reminder/recall for immunizations.

An alternative public-health based approach working in collaboration with regional or state immunization information systems can facilitate reminder/recall because such systems can identify children who need immunizations and generate reminder postcards or electronic data for centralized messaging.  

Research Question:

Which is more effective at increasing immunizations among preschool children:  practice-based reminder/recall or population-based reminder/recall conducted centrally by health departments using a regional or state immunization information system?


Which stakeholders (individuals and/or organizations) would you engage?

When in the research process, and how would you engage these stakeholders?

Study Population and Setting

Eligibility: What criteria will you use to select participants for your study?  How might this choice affect the generalizability of your findings?

Recruitment: What typed of approach will you use to recruit study participants?  How much effort will be made to recruit them?

Setting: Where should the trial be conducted?  What criteria will you use to select sites for the study?  How might this affect the generalizability of your findings?

Organization: What expertise and resources will be required to deliver the intervention?  How might this affect the generalizability of your findings?

Research Design

Research Design:  What trial design will you use?  Why?

Outcome Measure: What measures are relevant for your study participants?  For other stakeholders who will be using the results of the study?

Follow-Up Intensity: How often will you collect data?  How similar is this approach to usual care?  What data source(s) will you use?  Are they valid and reliable?   

Primary Analysis: Will you use an intention-to-treat analysis?  Why or why not?

Real-World Use

Flexibility (delivery):  To what degree will you monitor and enforce intervention fidelity?  How would this compare with flexibility allowed in usual care?

Flexibility (adherence):   To what degree will you monitor and encourage adherence to the intervention by study participants?  How would this compare with practices employed in usual care? 

Section Complete.

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