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5 New and Emerging Designs for Intervention Studies
Pages 51-70

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From page 51...
... summarized key points. DESIGNS FOR DISSEMINATION AND IMPLEMENTATION RESEARCH FOR SMALL POPULATIONS Amy Kilbourne provided an overview of implementation and dissemination research and examined key intervention study designs that focus on implementation strategies -- hybrid designs, stepped-wedge designs, and 51
From page 52...
... Implementation research is the scientific study of the use of strate gies to promote the uptake of evidence-based health interventions in clinical and community settings in order to improve patient/population outcomes. Different types of designs used in dissemination and implementation research include classic randomized controlled trials and pragmatic clinical trial designs, interrupted time series, dynamic wait list designs, and regression point displacement designs and stepped-wedge designs.
From page 53...
... Hybrid designs can compare the effectiveness of different implementation strategies or look at both effectiveness of a clinical intervention and the strategy used to implement that intervention. Stepped-wedge designs are often used in clustered ways, randomizing sites to different types of implementation strategies.
From page 54...
... A researcher observes the process to see whether or not the clinical intervention itself is effective. Hybrid Type III starts with an intervention that is presumably effective, but it is not known how best to implement and sustain it, so different implementation strategies are tested.
From page 55...
... The doctor-office collaborative care improved quality of care over usual care within a 12-month period. Kilbourne noted a Type III study requires an implementation strategy.
From page 56...
... It is essential to provide a community-based organization the opportunity to adapt interventions. Her first example of a Hybrid Type III study was a pioneering intervention in HIV prevention in small communities5 that compared the effectiveness of having only a packaged manual of an HIV prevention intervention delivered to an AIDS service organization, versus delivering the manual plus training, versus delivering the manual, training, and additional technical assistance.
From page 57...
... Kilbourne provided an example of a SMART design called the Adaptive Implementation of Effective Programs Trial, or ADEPT study.8 The research question was to determine the best way to implement a collaborative care model in community-based practices to improve patient mental health outcomes. The study was conducted in small practices in several counties across Michigan and Colorado.
From page 58...
... The response variable was an indicator of whether or not fewer than 50 percent of patients received three or more collaborative care model self-management sessions, an indication that providers were delivering the evidence-based collaborative care model. Future Directions Kilbourne concluded with her views on future directions in study designs for implementation research in small populations.
From page 59...
... Lu said that interrupted time series designs are useful when there is a sharply defined known time point of the intervention. That makes it easier to design the outcome measures and to take measurements before and after that time point.
From page 60...
... The longitudinal interrupted time series design used data from the Mental Health Research Network, part of the Health Care Systems Research Network. An advantage of data networks10 is that researchers do not have to collect, clean, and combine data from individual sites.
From page 61...
... Strengths and Challenges of Interrupted Time Series Lu said that the interrupted time series design is very useful when there is a sharply defined intervention to minimize biases due to co-intervention. It controls most common threats to internal validity because of the availability of historical trends in the outcome with and without control (com 11  Lu, C.Y., Soumerai, S.B., Ross-Degnan, D., Zhang, F., and Adams, A.S.
From page 62...
... She observed that it is possible to design an interrupted time series analysis using data for an outcome from a single person before and after a specific intervention. Lu said it is important to evaluate the impact of policies or interventions.
From page 63...
... should be addressed. She questioned whether health disparities research could inform resource distribution to address social determinants of health.
From page 64...
... She and her colleagues talked to five tribal partners about what they would recommend for data aggregation.14 The study timeline started in 2009, but partnerships started long before that to build relationships and establish trust. A conference was held with indigenous and tribal health leaders at the University of Washington to talk about data-related issues.
From page 65...
... INVITED DISCUSSANT Patrick Tolan noted he works in community-based, randomized controlled trials that are behavioral. They use schools as units.
From page 66...
... A number of designs and strategies can deal with those challenges, such as use of interrupted time series. He noted that many promising strategies have been discussed to recruit populations that are difficult to reach, marginalized, or may be hostile to engagement.
From page 67...
... Drawing on his research on parenting, terms mean different things and carry different weight to different people. For example, for a parenting intervention to be of interest to Mexican American families, it needed to address respect and responsibility, while non-Hispanic whites were interested in autonomy and development of independent capability and African-American parents were concerned with love, connection, and dependability.
From page 68...
... There has been pioneering research in the communities who serve the serious and persistent mentally ill on shared decision making and personalized health records as well. David Berrigan (National Cancer Institute)
From page 69...
... Kilbourne agreed and added that Korngiebel's thoughts about c ­ ommunity-based participatory research and user-centered design are the type of implementation strategies needed. They may quicken the evolution of what is thought of as an evidence-based practice into something better.


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