OBJECTIVE: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses\' moral distress, patient health-related quality of life and cost-effectiveness.
METHODS: Parallel two-arm, cluster-level randomized controlled trial.
METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.
RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the \'other\' ethnicity subgroup.
CONCLUSIONS: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients\' experience of care.
UNASSIGNED: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.
CONCLUSIONS: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients\' experience of care.
UNASSIGNED: CONSORT and CONSERVE.
UNASSIGNED: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

UNASSIGNED: Although shared treatment decision-making with patients requires attention, it is not widely implemented, particularly in the field of psychiatry. The aim of this study was to assess whether a shared decision-making (SDM) training program for clinicians based on the major depressive disorder (MDD) guidelines improved the perceived involvement of the decision process for patients with MDD.
UNASSIGNED: A multi-center cluster-randomized controlled intervention of a clinician training program based on the Japanese MDD guidelines using related decision aids compared to usual care was conducted among 56 clinicians from 23 institutions. A total of 124 patients with MDD were enrolled in this study. The primary outcomes were the scores of the Shared Decision Making-Questionnaire-9 (SDM-Q-9) and Decision Conflict Scale (DCS) after the first visit to the outpatient clinics. The secondary outcomes were patients\' satisfaction, quality of life, trust in clinicians, and depressive symptoms. Additionally, we evaluated all the observed outcomes at the first and third months of follow-up.
UNASSIGNED: The scores of the SDM-Q-9 in the SDM training program group were significantly higher than those in the control group at the first visit. However, no significant difference in the DCS scores was found between the two groups. There was no intervention effect for secondary outcomes and the outcomes at the first- and third-month follow-up visits.
UNASSIGNED: The clinician training program based on the Japanese MDD guidelines can be useful for implementation of SDM. Additional research is needed to confirm the efficacy of this SDM training program.
UNASSIGNED: [https://www.umin.ac.jp/], identifier [UMIN000034397].

Printed educational materials (PEMs) have long been used to inform clinicians on evidence-based practices. However, the evidence for their effects on patient care and outcomes is unclear. In Ontario, despite widely available clinical practice guidelines recommending antihypertensives and cholesterol-lowering agents for patients with diabetes, prescriptions remain low. We aimed to determine whether PEMs can influence physicians to intensify prescribing of these medications.
A pragmatic, 2 × 2 factorial, cluster randomized controlled trial was designed to ascertain the effect of two PEM formats on physician prescribing: a postcard-sized message (\"outsert\") or a longer narrative article (\"insert\"). Ontario family physician practices (clusters) were randomly allocated to receive the insert, outsert, both or neither. Physicians were eligible if they were in active practice and their patients were included if they were over 65 years with a diabetes diagnosis; both were unaware of the trial. Administrative databases at ICES (formerly the Institute for Clinical Evaluative Sciences) were used to link patients to their physician and to analyse prescribing patterns at baseline and 1 year following PEM mailout. The primary outcome was intensification defined as the addition of a new antihypertensive or cholesterol-lowering agent, or dose increase of a current drug, measured at the patient level. Analyses were by intention-to-treat and accounted for the clustering of patients to physicians.
We randomly assigned 4231 practices (39% of Ontario family physicians) with a total population of 185,526 patients (20% of patients with diabetes in Ontario primary care) to receive the insert, outsert, both, and neither; among these, 4118 practices were analysed (n = 1025, n = 1037, n = 1031, n = 1025, respectively). No significant treatment effect was found for the outsert (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.98 to 1.04) or the insert (OR 0.99, 95% CI 0.96 to 1.02). Percent of intensification in the four arms was similar (approximately 46%). Adjustment for physician characteristics (e.g., age, sex, practice location) had no impact on these findings.
PEMs have no effect on physician\'s adherence to recommendations for the management of diabetes-related complications in Ontario. Further research should investigate the effect of other strategies to narrow this evidence-to-practice gap.
ISRCTN72772651 . Retrospectively registered 21 July 2005.

OBJECTIVE: Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP) for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines.
METHODS: An international cluster randomized controlled trial was performed in Belgium, Italy and Portugal. General hospitals were randomly assigned to an intervention group where a CP was implemented or a control group where usual care was provided. The targeted population included patients with COPD exacerbation.
RESULTS: Twenty-two hospitals were included, whereof 11 hospitals (n=174 patients) were randomized to the intervention group and 11 hospitals (n=168 patients) to the control group. The CP had no impact on the 6 months readmission rate. However, the 30 days readmission rate was significantly lower in the intervention group (9.7%; 15/155) compared to the control group (15.3%; 22/144) (odds ratio =0.427; 95% confidence interval 0.222-0.822; P=0.040). Performance on process indicators was significantly higher in the intervention group for 2 of 24 main indicators (8.3%).
CONCLUSIONS: The implementation of this in-hospital CP for COPD exacerbation has no impact on the 6 months readmission rate, but it significantly reduces the 30 days readmission rate.

OBJECTIVE: The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines.
BACKGROUND: Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines \'End-of-life care in the intensive care unit, nursing care\'. Before intensive care nurses are able to use these guidelines, they needs to be implemented in clinical practice. Implementation is a complex process and may need support.
METHODS: Cluster randomized controlled trial.
METHODS: Intensive care nurses of eight intensive care units in the intervention group followed a supportive programme that educated them on implementation, strategies, goals, project management and leadership. The intervention group focused on a stepwise approach to implement the guidelines. The control group (n = 5) implemented the guidelines independently or used the standard implementation plan supplementary to the guideline. The effectiveness of the programme was measured using questionnaires for nurses, interviews with nurses and a questionnaire for family of deceased patients, in the period from December 2014-December 2015.
RESULTS: Overall, an increase in adherence to the guidelines was found in both groups. Overall, use of the guidelines in the intervention group was higher, but on some aspects the control group showed a higher score. Care for the patient and the overall nursing care scored significantly higher according to family in the intervention group.
CONCLUSIONS: The increase in adherence to the guidelines and the significantly higher satisfaction of family in the intervention group indicate that the supportive programme had a more positive effect.