Case Example
Practice and apply the principles of pragmatic clinical trials
Instructions
- Read the background, context and study question of the case example
- For each module, fill in your responses, you may review content and resources where indicated.
- Once you've completed the module, review your responses and compare them to the written debrief.
Background and Context
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?
Engagement
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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References
The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant.
Methods. This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD.
Results. Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P < .001); 31.8% had documented receipt of 1 or more vaccines in Pop-recall versus 22.6% in PCP-recall counties (P < .001). Relative risk estimates from multivariable modeling were 1.23 (95% confidence interval [CI] = 1.10, 1.37) for becoming UTD and 1.26 (95% CI = 1.15, 1.38) for receipt of any vaccine. Costs for Pop-recall versus PCP-recall were $215 versus $1981 per practice and $17 versus $62 per child brought UTD.
Conclusions. Population-based recall conducted centrally was more effective and cost-effective at increasing immunization rates in preschool children.
www.Precis-2.org