Quality improvement experts examine case studies from around the world 

On the third day of the Salzburg Global Seminar session Better Health Care: How do we learn about improvement? following input from expert faculty, Fellows expand work on their case studies and consider how they can improve the rigor, attribution and generalizability.

Nurse-led Intensive Home-visitation program in the UK

For a full summary, download the case study as a PDF.

Background: The Family Nurse Partnership (FNP) is an intensive home-visiting intervention to help teen mothers and their children in the UK. The intervention was based on an intervention developed and found to be effective in the US. Methods: A randomized controlled trial of teen mothers and their children, who were recruited at 18 healthcare organizations in England. Mothers either received the FNP intervention (up to 64 structured home visits by trained nurses from early pregnancy until the child’s second birthday) plus usual care (i.e., publicly funded health and social care) or usual care only. Primary outcomes were tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Results: Altogether, 823 women received the FNP intervention + usual care, and 822 received usual care only. There were no differences in any primary outcome between the two study groups. Conclusion: Adding FNP to the usually provided health and social care provided no additional short-term benefit to the primary outcomes. 

 Why was there no effect found in the UK trial?

1. Teen mothers in UK study might not have been, on average, as high-risk as mothers in other studies that found an effect. Although UK researchers examined high-risk subgroups and found no interactions, but this could be explored further.
2. The “usual care” interventions in the comparison group might have been better than those in US studies, so the FNP intervention had less to offer in an additive way.
3. The UK study had a 2-year follow-up period, but US studies had 4 or 6-year follow-up. It might take a longer follow-up time to identify benefits.
4. UK study was done 20 years after the US study, so context was likely different.

Principles that we identified that might be useful for others doing this kind of research:

1. If you’re going to replicate a study, collaborate with the investigators of the original study to really understand the strategy and the study methods.
2. Have an adequate follow-up period—especially if you’re replicating results of another study that had a longer follow-up period than what you’re planning.
3. Think about the degree to which a new strategy truly adds to “usual care” that controls are receiving.
4. Study heterogeneity in outcomes and publish those results.
5. Pragmatic trials are useful, as they show strategy effects in a typical context.
6. Investigators should describe interventions in sufficient detail (e.g., content of home visits) and the “usual care” interventions. Qualitative results might be useful for these descriptions. In a publication, if these end up in web appendices, alert readers to these appendices so they’re easy to find.
7. Bayesian adaptive trial methods allow for adaptation of a strategy after a trial has begun.