EHMTI-0266. Validation of a sham manipulative procedure: a new protocol for conducting placebo-control clinical trials in manual therapy

Background: Few manual therapy studies have attempted to conduct placebo-control clinical trials. Thus, quantification of alleged placebo effects consequently becomes difficult. Aim: To investigate and validate a new placebo intervention for spinal manipulative therapy clinical trials, i.e. sham manipulation, and investigate the feasibility of a short de-blinding questionnaire. Method: A single blinded, prospective randomized, placebo-controlled trial with 1 month baseline and 3 months treatment with 12 treatments. 104 participants diagnosed with migraine were equally randomized into 1 of 3 groups: (i) chiropractic spinal manipulative therapy (CSMT), (ii) placebo (sham manipulation), (iii) control group (continued usual management). The participants filled in questionnaire on de-blinding after each treatment session. Primary end-point was the rate of successful blinding through de-blinding questionnaires given after each treatment session. Results: 772 out of 840 individual cases were analyzed, only 8.1 % out of all cases missed their appointment. The unadjusted result shows that both the active and placebo group believed they received active treatment with odds ratio (OR) of ≥88.9 and ≥80.0 respectively. Due to strong cluster effect in our data, logistic regression model was used to adjust for repeated measures which showed a significant OR of >10 in both the active and the placebo group. Conclusion: This is the first study to successfully demonstrate a manipulative sham procedure over a full length treatment period, assessing the placebo group with de-blinding questionnaire after each session which thus, could be incorporated in future clinical trials.1 page(s

Psychiatric admissions from crisis resolution teams in Norway: a prospective multicentre study

Background Crisis resolution teams (CRTs) provide intensive alternative care to hospital admission for patients with mental health crises. The aims of this study were to describe the proportions and characteristics of patients admitted to in-patient wards from CRTs, to identify any differences in admission practices between CRTs, and to identify predictors of admissions from CRTs. Methods A naturalistic prospective multicentre design was used to study 680 consecutive patients under the care of eight CRTs in Norway over a 3-month period in 2005/2006. Socio-demographic and clinical data were collected on the patients, and on the organization and operation of the CRTs. Logistic regression analysis for hierarchical data was used to test potential predictors of admission at team and patient level. Results One hundred and forty-six patients (21.5%) were admitted to in-patient wards. There were significant differences in admission rates between the CRTs. The likelihood of being admitted to an in-patient ward was significantly lower for patients treated by CRTs that operated during extended opening hours than CRTs that operated during office hours only. Those most likely to be admitted were patients with psychotic symptoms, suicidal risk, and a prior history of admissions. Conclusions Extended opening hours may help CRTs to prevent more admissions for patients with moderately severe and relapsing mental illnesses. Patients with severe psychosis seem to be difficult to treat in the community by Norwegian CRTs even with extended opening hours

Cost analysis of day care centres in Norway

Background Day care services aim to offer meaningful activities and a safe environment for the attendees and a respite for family caregivers while being cost effective. This study compares the use of formal and informal care in users and non-users of day care centres designed for persons with dementia. Method Users of day care designed for dementia (DC group) and non-users (NDC group) were followed over a period of 24 months or until nursing home admission (NHA) respectively death. Demographic and clinical characteristics were collected at baseline and after 12 and 24 months. The use of care was recorded by Resource Utilization in Dementia (RUD). Results A total of 257 persons with dementia participated in the study, 181 in the DC group and 76 in the NDC group. Users of day care centres cause higher costs due to the expenses for day care, while neither the use of home nursing, secondary care, informal care nor the time until NHA did show any differences between users and non-users. The overall costs were higher in the DC group at baseline and after 12 months, but this difference was no longer present at the end of the two-year study period. Conclusion Our results indicate no potential cost-saving effect of day care designed for people with dementia, as the use of day care did neither result in a reduced use of care nor in a delay of NHA. Future research should balance the non-monetary benefits of day care against its costs for a full cost-effectiveness analysis, most favourable in a RCT-design

Impact of a dementia-friendly program on detection and management of patients with cognitive impairment and delirium in acute-care hospital units: a controlled clinical trial design

Background Frail older persons with cognitive impairment (CI) are at special risk of experiencing delirium during acute hospitalisation. The purpose of this study was to investigate whether a dementia-friendly hospital program contributes to improved detection and management of patients with CI and risk of delirium at an acute-care hospital in Norway. Furthermore, we aimed to explore whether the program affected the detection of delirium, pharmacological treatment, 30-day re-hospitalisation, 30-day mortality and institutionalisation afterwards. Methods This study was part of a larger quality improvement project aiming at developing and implementing a new program for early screening and management of patients with CI. This study, evaluating the program are designed as a controlled clinical trial with a historical control group. It was conducted at two different medical wards at a large acute-care hospital in Norway from September 2018 to December 2019. A total of 423 acute hospitalised patients 75 years of age or older were included in the study. Delirium screening and cognitive tests were recorded by research staff with the 4 ‘A’s Test (4AT) and the Confusion Assessment Measure (CAM), while demographic and medical information was recorded from the electronic medical records (EMR). Results Implementation of the dementia-friendly hospital program did not show any significant changes in the identification of patients with CI. However, the share of patients screened with 4AT within 24 h increased from 0% to 35.5% (P < .001). The proportion of the patients with CI identified by the clinical staff, who received measures to promote “dementia-friendly” care and reduce the risk for delirium increased by 32.2% (P < .001), compared to the control group. Furthermore, the number of patients with CI who were prescribed antipsychotic, hypnotic or sedative medications was reduced by 24.5% (P < .001). There were no differences in delirium detection, 30-day readmission or 30-day mortality. Conclusions A model for early screening and multifactorial non-pharmacological interventions for patients with CI and delirium may improve management of this patient group, and reduce prescriptions of antipsychotic, hypnotic and sedative medications. The implementation in clinical practice of early screening using quality improvement methodology deserves attention. Trial registration The protocol of this study was retrospectively registered in the ClinicalTrials.gov Protocol Registration and Results System with the registration number: NCT04737733 and date of registration: 03/02/2021