Treatment device decision aids for youth with type 1 diabetes and their parents / Tim Wysocki [and ten others].

Format:

Book

Author/Creator:

Wysocki, Tim, author.

Series:

Final research report (Patient-Centered Outcomes Research Institute (U.S.))

Language:

English

Subjects (All):

Insulin pumps.

Physical Description:

1 online resource (67 pages) : illustrations.

Place of Publication:

Washington, D.C. : Patient-Centered Outcomes Research Institute (PCORI), 2019.

Summary:

BACKGROUND: The "Holy Grail" of health care delivery science, getting the right care to the right patient at the right time, is uncommon among adolescents with type 1 diabetes (T1D). Although technological advances offer great potential for improved care outcomes, adolescents tend to derive limited benefit from them. OBJECTIVE: This study evaluated a shared medical decision-making (SDM) intervention, developed with extensive stakeholder engagement, in terms of the quality of decision-making and other key outcomes among adolescents with T1D. METHODS: With extensive adolescent and parent involvement, the research team constructed 2 multimedia decision aids (DAs) for adolescents with T1D and their parents who were considering the adoption of either continuous subcutaneous insulin infusion (CSII/insulin pump) or continuous glucose monitoring (CGM). Once the DAs were completed, we conducted a randomized controlled trial (RCT) of SDM vs usual clinical practice (UCP). A sample of 153 adolescent-parent dyads enrolled in the RCT, of whom 133 completed all baseline measures and were randomized to SDM (n = 66) or UCP (n = 67). We collected outcome measures before, during, and after the CSII/CGM decision-making process. To address the research questions, we fit statistical models for the primary outcome (CSII/CGM Use Profile, a measure of meticulousness of CSII or CGM use) and secondary outcomes: measures of T1D treatment adherence, glycated hemoglobin (HbA1C), incidence of severe hypoglycemia, satisfaction with current T1D devices, and decision quality. RESULTS: The qualitative component of the project yielded a detailed account of stakeholder perspectives of CSII/CGM decision-making from adolescents with T1D and their parents as well as multiple health care providers who select and prepare candidate patients for adoption of these technologies. Stakeholders also offered perspectives for optimizing the CSII or CGM decision-making process. These qualitative data informed the design and construction of the multimedia online DAs that were central to the SDM intervention tested in the subsequent RCT. In the RCT, neither the main effect for groups (SDM vs UCP) nor the group by time interaction effect on the primary outcome (CSII/CGM Use Profile) achieved statistical significance. The Diabetes Self-management Profile (parent-report of treatment adherence) was the RCT outcome variable that yielded statistically significant treatment effects favoring SDM , and SDM was marginally associated with lower HbA1C than UCP (p = 0.06). None of the other secondary outcomes yielded statistically significant effects demonstrating superiority of SDM over UCP. CONCLUSIONS: Principles of user-centered design can engage stakeholders in the creation of online, multimedia DAs targeting decision-making among adolescents with T1D and their parents, who are considering the adoption of CSII or CGM into their care. The primary outcome (CSII/CGM Use Profile scores) was similar in the SDM and UCP groups. Only a few significant treatment effects favoring the SDM intervention emerged, and the key markers of decision quality did not differ between the SDM and UCP groups. LIMITATIONS: In addition to the relatively small sample size, many enrolled participants had extensive preexisting knowledge of CSII or CGM and firmly preconceived opinions about the merits of the treatment alternative they were considering. Others were clearly in an information-seeking mode, but they had not determined if they would pursue CSII or CGM despite their physicians' encouragement. Adolescents and parents who enter into an SDM process do so with diverse perspectives, differing knowledge levels, and varied receptivity to open-minded consideration of available treatment options. The heterogeneity of the sample along these dimensions might have inhibited the capacity to detect clinically meaningful treatment effects in this study.

Contents:

Background

Participation of Patients and Other Stakeholders as Members of the Research Team

Methods

Results

Discussion

Conclusions

References

Related Publications

Acknowledgments

Appendix.

Notes:

Description based on publisher supplied metadata and other sources.