The findings from the preliminary discussion group included adapting the child simulator to include a computerized `bleeding finger' to practice and review blood glucose monitoring, the addition of fat pads on arms and legs to practice injections, and the ability to add voiceovers such as “my tummy hurts,”, “can I have some candy?”, and “I don't feel good.” During this discussion we also developed the shell of three teaching vignettes: hypoglycemia, hyperglycemia, and sick day management that would be further refined for the full randomized controlled trial (based on our pilot findings).
Focus group findings
The focus groups had parents whose children had a mean duration of illness of 45 months, compared to the second focus group with a mean duration of only 5 months. There was a difference in initial length of hospital stay, with the first group having spent a mean of 9 days (due to medical complications or other acute illnesses) and the second group only 3 days.
Regarding timing and content, both focus groups stressed limiting the amount of information shared with parents immediately after diagnosis. One father stated that learning diabetes management is a two-phase process: Phase 1). very mechanical (survival mode), and Phase 2). more complex and abstract (begin to think critically about what you are doing and its consequences) (See ). Both groups recommended using the pediatric HPS to teach basic skills during the hospitalization or shortly after and having a second session one month after diagnosis to focus on more complex diabetes management concepts, followed by a 3 month teaching session where diabetes management information could be pulled together and reviewed. One father whose child was only 3 months post diagnosis, was unsure about the value of simulation teaching; but the majority thought it was a good idea with several stating they would have wanted to be shown everything up front. One mother stated it was a `detached introduction.' Both groups recommended offering the observation and practice of the tremors as an optional component initially. Offering 3 teaching sessions (baseline, 1 and 3 months) was well received and perceived as a way to build and strengthen knowledge and skills over the course of those stressful months after diagnosis.
Pilot study I findings
There were 8 female and 2 male caregivers whose median age was 41 years, with a range of 12–14 years of education. There were 6 girls and 4 boys who ranged in age from 7 to 13 years with the majority (n=7) having been recently diagnosed (under 2 months) and the other three within the past year. The parents interviewed (n=5) stated the tremors and seizures were good to see (not scary) but could have been stronger since some of the parents had heard sometimes children will thrash with seizure activity. Several parents shared that the teaching sessions would be helpful for their older child as well. The parents shared that the questionnaires were easy to access and complete (on average, 40 minutes). The diabetes educator reported that the vignette interactions with the parents were more focused; and the HPS was a nice way to illustrate tremors.
Pilot Study II Findings
Over a 6 week time span we recruited/consented 16 participants. All subjects had children who were newly diagnosed with T1D. The sample included 13 female and 3 male caregivers, 15 White and 1 Latina; mean age was 42 years old, with 15.4 years of education. The children's mean age was 8 years. Only one mother in the experimental group stated she did not like the simulator (because she has a fear of clowns). All other participants reported it was helpful to practice how to treat hypoglycemia with the pediatric HPS. We were able to easily recruit 16 subjects from only one site within 6 weeks. The opportunity for additional diabetes education was seen as advantageous by the parents.
We were able to demonstrate strong reliability with all of the instruments (See ). Most important, there was a mean change from baseline in the predicted direction for all measures. This change also occurred with the trait portion of the STAII, which is supposed to remain stable over time. The diabetes educators reported similar parent positive teaching experiences when using HPS. One father reported to the educator that he didn't like to read so this was helpful.
Another important finding from the pilot was the need for close coordination between the parents schedules and the teaching session times (for both experimental and control arms). We have adapted the procedure manual to accommodate this finding.