ABSTRACT
BACKGROUND: The implementation of person-centred, need-oriented and flexible care for people with substance-related problems is often insufficient, in large part due to the complexity of addiction support services among different providers. A standardized online assessment and subsequent sector-independent treatment coordination could provide individuals with more appropriate services, thereby making better use of individual services and leading to a more effective addiction support system as a whole. The aim of this study is to determine the effectiveness and cost-effectiveness of sector-independent treatment coordination following an online assessment, in comparison with the current standard of care and treatment process in Germany. METHODS: The sample size of this randomized, controlled trial has been set to a total of 400 participants with substance-related problems. Participants living in Stuttgart, Germany, will be randomly allocated to (1) the intervention group with immediate online assessment and subsequent sector-independent treatment coordination (ASSIST) or (2) the waitlist group. Participants in the waitlist group will initially remain in usual care and only be provided with the online assessment 6 months later. Short-term effects (over 2 months) and medium-term effects (over 6 months) of ASSIST will be compared between the intervention and the waitlist groups. The primary outcome is improved treatment satisfaction. Secondary outcomes include improved subjective quality of life and empowerment, reductions in patients' substance use, unmet needs and illness-related clinical and social impairment. Health economic evaluation as well as quantitative and qualitative process evaluations will be conducted. DISCUSSION: The results of this study are expected to provide information on whether sector-independent treatment coordination following an online assessment contributes to improved health care service provision for people with substance-related problems. This randomized controlled trial will help identify facilitators and barriers to the sustainable implementation of a cross-sectoral care concept in substance abuse services. TRIAL REGISTRATION: German Clinical Trial Register DRKS00026996 . Registered on 29 October 2021.
Subject(s)
Quality of Life , Substance-Related Disorders , Cost-Benefit Analysis , Germany , Humans , Randomized Controlled Trials as Topic , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapyABSTRACT
BACKGROUND: The obstructive sleep apnea syndrome (OSAS) is characterized by intermittent cerebral hypoxia which can cause cognitive alterations. Likewise, hypoxia induced neurocognitive deficits are detectable after general anesthesia using volatile anesthetics. The objective of this study was to evaluate the association between a moderate to high risk patients of OSAS and postoperative cognitive dysfunction after volatile anesthesia. METHODS: In this single center prospective, observational study between May 2013 and September 2013, 46 patients aged 55 to 80 years with an estimated hospital stay of at least 3 days undergoing surgery were enrolled. Patients were screened using the STOP-BANG test with score of 3 or higher indicating moderate to high risk of OSAS. The cognitive function was assessed using a neuropsychological assessment battery, including the DemTect test for cognitive impairment among other tests e.g. SKT memory, the day before surgery and within 2 days after extubation. RESULTS: Twenty-three of the 46 analyzed patients were identified with a moderate to high risk of OSAS. When comparing post- to preoperative phase a significant better performance for the SKT was found for both groups (p < 0.001). While the moderate to high risk group scores increased postoperative in the DemTect test, they decreased in the low risk group (p < 0.003). When comparing the changes between groups, the moderate to high risk patients showed significant better test result for DemTect testing after anaesthesia. This effect remained robust when adjusting for potential confounding variables using a two-factor ANOVA. CONCLUSION: Compared to low risk, a moderate to high risk of OSAS based on the STOP-BANG score was associated with improved postoperative cognitive function measured by the DemTect test. TRIAL REGISTRATION: The study was approved by the local Ethics committee (Ethikkommission der Medizinischen Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany) (reference number: 87_12 B ) on 19.04.2012.