scholarly journals The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Machelle Wilchesky ◽  
Stephanie A. Ballard ◽  
Philippe Voyer ◽  
Jane McCusker ◽  
Ovidiu Lungu ◽  
...  

Abstract Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. Methods The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45–50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400–600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. Discussion This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. Trial registration NCT03718156, ClinicalTrials.gov.

2020 ◽  
Author(s):  
Kyoung Ja Moon ◽  
Chang-Sik Son ◽  
Jong-Ha Lee ◽  
Mina Park

BACKGROUND Long-term care facilities demonstrate low levels of knowledge and care for patients with delirium and are often not properly equipped with an electronic medical record system, thereby hindering systematic approaches to delirium monitoring. OBJECTIVE This study aims to develop a web-based delirium preventive application (app), with an integrated predictive model, for long-term care (LTC) facilities using artificial intelligence (AI). METHODS This methodological study was conducted to develop an app and link it with the Amazon cloud system. The app was developed based on an evidence-based literature review and the validity of the AI prediction model algorithm. Participants comprised 206 persons admitted to LTC facilities. The app was developed in 5 phases. First, through a review of evidence-based literature, risk factors for predicting delirium and non-pharmaceutical contents for preventive intervention were identified. Second, the app, consisting of several screens, was designed; this involved providing basic information, predicting the onset of delirium according to risk factors, assessing delirium, and intervening for prevention. Third, based on the existing data, predictive analysis was performed, and the algorithm developed through this was calculated at the site linked to the web through the Amazon cloud system and sent back to the app. Fourth, a pilot test using the developed app was conducted with 33 patients. Fifth, the app was finalized. RESULTS We developed the Web_DeliPREVENT_4LCF for patients of LTC facilities. This app provides information on delirium, inputs risk factors, predicts and informs the degree of delirium risk, and enables delirium measurement or delirium prevention interventions to be immediately implemented with a verified tool. CONCLUSIONS This web-based application is evidence-based and offers easy mobilization and care to patients with delirium in LTC facilities. Therefore, the use of this app improves the unrecognized of delirium and predicts the degree of delirium risk, thereby helping initiatives for delirium prevention and providing interventions. This would ultimately improve patient safety and quality of care. CLINICALTRIAL none


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wienbergen ◽  
A Fach ◽  
S Meyer ◽  
J Schmucker ◽  
R Osteresch ◽  
...  

Abstract Background The effects of an intensive prevention program (IPP) for 12 months following 3-week rehabilitation after myocardial infarction (MI) have been proven by the randomized IPP trial. The present study investigates if the effects of IPP persist one year after termination of the program and if a reintervention after >24 months (“prevention boost”) is effective. Methods In the IPP trial patients were recruited during hospitalization for acute MI and randomly assigned to IPP versus usual care (UC) one month after discharge (after 3-week rehabilitation). IPP was coordinated by non-physician prevention assistants and included intensive group education sessions, telephone calls, telemetric and clinical control of risk factors. Primary study endpoint was the IPP Prevention Score, a sum score evaluating six major risk factors. The score ranges from 0 to 15 points, with a score of 15 points indicating best risk factor control. In the present study the effects of IPP were investigated after 24 months – one year after termination of the program. Thereafter, patients of the IPP study arm with at least one insufficiently controlled risk factor were randomly assigned to a 2-months reintervention (“prevention boost”) vs. no reintervention. Results At long-term follow-up after 24 months, 129 patients of the IPP study arm were compared to 136 patients of the UC study arm. IPP was associated with a significantly better risk factor control compared to UC at 24 months (IPP Prevention Score 10.9±2.3 points in the IPP group vs. 9.4±2.3 points in the UC group, p<0.01). However, in the IPP group a decrease of risk factor control was observed at the 24-months visit compared to the 12-months visit at the end of the prevention program (IPP Prevention Score 10.9±2.3 points at 24 months vs. 11.6±2.2 points at 12 months, p<0.05, Figure 1). A 2-months reintervention (“prevention boost”) was effective to improve risk factor control during long-term course: IPP Prevention Score increased from 10.5±2.1 points to 10.7±1.9 points in the reintervention group, while it decreased from 10.5±2.1 points to 9.7±2.1 points in the group without reintervention (p<0.05 between the groups, Figure 1). Conclusions IPP was associated with a better risk factor control compared to UC during 24 months; however, a deterioration of risk factors after termination of IPP suggests that even a 12-months prevention program is not long enough. The effects of a short reintervention after >24 months (“prevention boost”) indicate the need for prevention concepts that are based on repetitive personal contacts during long-term course after coronary events. Figure 1 Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Stiftung Bremer Herzen (Bremen Heart Foundation)


2018 ◽  
Vol 24 (9) ◽  
pp. 769-772 ◽  
Author(s):  
Hideharu Hagiya ◽  
Norihisa Yamamoto ◽  
Ryuji Kawahara ◽  
Yukihiro Akeda ◽  
Rathina Kumar Shanmugakani ◽  
...  

2019 ◽  
Author(s):  
Paul Aujoulat ◽  
Patrice NABBE ◽  
Sophie LALANDE ◽  
Delphine LE GOFF ◽  
Jeremy DERRIENIC ◽  
...  

Abstract Background: the European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. Detecting risk factors for decompensation would be an interesting challenge for family physicians (FPs) in the management of multimorbid patients. The purpose of the survey was to assess which items belonging to the EGPRN multimorbidity definition could help to identify patients at risk of decompensation in a cohort pilot study over a 24-month follow-up among primary care outpatients. Method : 131 patients meeting the multimorbidity definition were included using two inclusion periods between 2014 and 2015. Over a 24-month follow-up, the « decompensation » or « nothing to report » status was collected. A logistic regression, following a Cox model, was then performed to identify risk factors for decompensation. Results : After 24 months of follow-up, 120 patients were analyzed. 3 clusters were identified. 44 patients, representing 36.6 % of the population, were still alive and had not been hospitalized for a period exceeding 6 days. Two variables were significantly linked to decompensation: the number of visits to the FP per year (HR 1.06, IC 95 %, 1,03-1,10, p-value <0,001) and the total number of diseases (HR 1,12, IC 95 %, 1,013-1,33, p-value = 0,039). Conclusion: FPs should be aware that a high number of consultations and a high total number of diseases are linked to severe outcomes such as death or unplanned hospitalization. A large-scale cohort in primary care seems feasible to confirm these results.


2013 ◽  
pp. 98-102
Author(s):  
Andrew Clegg ◽  
John Young

Background: Delirium is a common, but potentially preventable complication of acute illness that is associated with important adverse outcomes including increased length of hospital admission, risk of dementia and admission to long-term care. In-hospital risk assessment and diagnosis: Age over 65, severe illness, current hip fracture and presence of cognitive impairment or dementia are important risk factors for delirium. Assess people with any of these risk factors for recent changes or fluctuations in behaviour that might indicate delirium. If any indicators are present, complete a full cognitive assessment to confirm the diagnosis of delirium. In-hospital risk management: Multicomponent delirium prevention interventions can reduce the incidence of delirium in hospital by around one third and should be provided to people with any of the important risk factors that do not have delirium at admission. A medication review that considers both the number and type of prescribed medications is an important part of the multicomponent delirium prevention intervention. Which medications to avoid in people at risk of delirium: For people at risk of delirium, avoid new prescriptions of benzodiazepines or consider reducing or stopping these medications where possible. Opioids should be prescribed with caution in people at risk of delirium but this should be tempered by the observation that untreated severe pain can itself trigger delirium. Caution is also required when prescribing dihydropyridines and antihistamine H1 antagonists for people at risk of delirium and considered individual patient assessment is advocated. Conclusion: Delirium is common, distressing to patients, relatives and carers and is associated with important adverse outcomes. Multicomponent delirium prevention interventions can reduce the incidence of delirium by approximately one third and usually incorporate a medication review. Identification of which medications to avoid in people at risk of delirium will help guide evidence-based decision making.


2021 ◽  
Author(s):  
IkeOluwapo Oyeneye Ajayi ◽  
Oyediran Emmanuel Oyewole ◽  
Okechukwu S Ogah ◽  
Joshua Odunayo Akinyemi ◽  
Mobolaji Modinat Salawu ◽  
...  

Abstract Background: Nigeria’s healthcare system capacity to stem the increasing trend in hypertension is limited in coverage, scope and manpower. Use of trained community-based care providers demonstrated to be an effective complement in improving access to, and supporting healthcare delivery has not been adequately examined for hypertension care in Nigeria. This study is proposed to evaluate the effectiveness of using trained Community-based Oriented Resource Persons (CORPs) to improve hypertension control in Nigeria. Methods: An intervention study will be conducted in three states using mixed method design. First, is a baseline survey using a semi-structured pre-tested questionnaire to collect information on demographics, clinical data, knowledge, occurrence and risk factors of hypertension among 1,704 adults ≥18 years. Focus Group Discussions (FGD) and Key Informant Interviews (KII) will be conducted to explore community’s experience of hypertension, challenges with hypertension management, and support required to improve control in 10 selected communities in each state. The second is a cluster randomized controlled trial to evaluate effect of a package on reduction of blood pressure (BP) and prevention of cardiovascular (CVD) risk factors among 200 hypertensive patients to be followed up in intervention and control arms over a six-month period in each state. The package will include trained CORPs conducting community-based screening of BP and referral, diagnosis confirmation and initial treatment in the health facility, followed by monthly home-based follow-up care and provision of health education on hypertension control and healthy lifestyle enhanced by phone voice message reminders. In the control arm, the usual care (diagnosis, treatment and follow up care in hospital of patient’s choice) will continue. Third, an end-line survey will be conducted in both intervention and control communities to evaluate changes in mean BP, control, knowledge, and proportion of other CVD risk factors. In addition, FGD and KII will be used to assess participants’ perceived quality and acceptability of the interventions as delivered by CORPs.Discussion: This research is expected to create awareness, improve knowledge, perception, behaviours, attitude and practices that will reduce hypertension in Nigeria. Advocacy for buy-in and scale up of using CORPs in hypertension care by the government is key if found to be effective. Trial registration: PACTR Registry- PACTR202107530985857. Registered on 26 July 2021Url – https://pactr.samrc.ac.za


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Chun-hui Dong ◽  
Chao-nan Gao ◽  
Xiao-hua An ◽  
Na Li ◽  
Le Yang ◽  
...  

Abstract Background Dexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery. Methods This was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between − 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments. Results We assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665–0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672–0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS. Conclusions Prophylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period. Trial registration ChiCTR, ChiCTR1800014314. Registered 5 January 2018, http://www.chictr.org.cn/index.aspx


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