RESUMEN
BACKGROUND: Treatment decisions in metastatic melanoma (MM) depend on patient preferences and require the patients' involvement in the decision-making process. Patients often feel overwhelmed by the complexity of treatment options with their individual advantages and disadvantages. We developed an online patient decision aid (PtDA) to facilitate shared decision making (SDM). METHODS: We conducted a two-center, two-armed, prospective, open randomized controlled trial with MM patients who were facing a decision about first-line treatment. They were randomly allotted (1:1) to the use or non-use of the PtDA before discussing the choice of treatment with a physician (intervention group [IG] and control group [CG], respectively). The primary endpoint of the study was patient knowledge about first-line treatment options (multiple-choice test, 10 items, range 0-40 points). The secondary endpoints were the degree of SDM (ratings of audio recordings of the patient-physician discussions by third-party observers) and satisfaction with the decision that was taken on later follow-up. RESULTS: 120 of the 128 randomized patients completed the baseline questionnaire and were included in the analysis (59% male, median age 66 years). The primary endpoint, i.e., the mean difference in knowledge after discussion with a physician, was significantly higher in the intervention group (mean difference -3.22, 95% CI [-6.32;-0.12], p = 0.042). No difference was found in either of the secondary endpoints (SDM and satisfaction with the decision). The patients in the intervention group rated the PtDA as very useful. CONCLUSION: PtDA improved MM patients' knowledge about their options for treatment. Both patients who used it and patients who did not were highly satisfied with their treatment decisions. Additional physician training seems necessary to promote SDM.
RESUMEN
BACKGROUND: Access to outpatient mental healthcare can be challenging for patients. In Germany, a national structural reform was implemented in 2017 to accelerate and enhance access to outpatient psychotherapy and reduce waiting times. During the first phase of the study 'Evaluation of a structural reform of the outpatient psychotherapy guideline (ES-RiP)' and embedded into a process evaluation, the implementation was to be evaluated through assessing general practitioners' (GPs) and psychotherapists' (PTs) perspectives regarding utilization of provided new measures, and perceived potential for optimization. Particular focus was on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs). METHODS: This exploratory cross-sectional qualitative study used on-site and online focus group discussions and semi-structured telephone interviews with GPs and outpatient PTs. Generated data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze participant characteristics collected via a socio-demographic questionnaire. RESULTS: Perspectives on the structural reform were heterogenous. GPs and PTs considered the component of timely initial psychotherapeutic assessment consultations beneficial. GPs disapproved of their deficits in detailed information about the structural reform and exchange with outpatient PTs. Improvement suggestions included structured short information exchange and joint quality circles. The overall number of available outpatient PTs in rural areas was perceived as insufficient. For patients with cMPs, GPs saw patient barriers for therapy access and continuity in low intrinsic motivation, physical impediments and older age. PTs also saw patient challenges regarding low intrinsic motivation and keeping scheduled appointments. They considered post-reform administrative efforts to be high and reported that the regulations (conformity) lead to planning difficulties and financial losses. Reform elements were tailored to fit in with PTs key therapy areas. Stronger networking and joint lectures were suggested as remedy for the currently still limited exchange with GPs. Unlike the GPs, PTs emphasized that accepting patients into psychotherapeutic treatment was independent of a possibly present chronic physical disease. CONCLUSIONS: The findings contribute to understanding the integration of the delivered structural reform into daily care processes and provide an indication about reached targets and potential improvements. Further phases of the ES-RiP study can build on the findings and broaden insights. TRIAL REGISTRATION: Registration-ID DRKS00020344 (DRKS German Register of Clinical Trials.
