Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

High-calorie glucose-rich food attenuates neuroglycopenic symptoms in patients with Addison's disease.

CONTEXT/OBJECTIVE: Patients with Addison's disease often suffer from fatigue, faintness, lack of concentration, and memory deficits, i.e. symptoms reminiscent of those of neuroglycopenia. Suspecting that a lack of central nervous glucose contributes to these symptoms, we examined whether they can be attenuated by the intake of palatable food rich in glucose ("comfort food") in these patients and, furthermore, whether comfort food reduces hypothalamus-pituitary-adrenal axis activity as observed in animal studies. Design/Setting/Patients/Outcome: Ten Addison patients with primary adrenal insufficiency and acutely discontinued cortisol substitution and 10 matched healthy controls each participated in two experimental sessions in which they were offered a free-choice high-calorie buffet (comfort food) and green salad, respectively, after a mental stress test. Neuroglycopenic and autonomic symptoms, cognitive function (short-term memory, attention), and hormones of the sympathoadrenal system (ACTH, cortisol, catecholamines) were assessed throughout the sessions. RESULTS: Scores of neuroglycopenic symptoms were persistently higher in Addison patients than in controls and were improved by comfort food in comparison to salad (P < 0.04), whereas control subjects did not show such changes. Attention was generally reduced in patients as compared to controls (P < 0.05) and was slightly improved by comfort food, as was memory (each P < 0.07). Sympathoadrenal hormone concentrations remained unaltered. CONCLUSIONS: High-calorie comfort food reduces symptoms of neuroglycopenia in Addison patients, suggesting that Addison's disease is associated with a deficit in cerebral energy supply that can partly be alleviated by intake of palatable food. It will be important to investigate whether additional oral glucose supply may be helpful in improving patients' well-being.