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The "Wholesome Contact" non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial.

ABSTRACT: In hospital settings, delirium affects as many as 50% of older patients, aggravating their symptoms and worsening their condition, and therefore increasing the risk of in-hospital complications and death. The aim of this study is to assess the efficacy of structured, non-pharmacological care, delivered to older hospitalised patients by trained volunteers (students of medical fields), on the reduction of incidence of adverse health-related outcomes.This trial will be a randomised, investigator-blind, controlled trial conducted in an internal medicine and geriatric ward in Poland. We aim to include 416 patients who are 70 years of age and have been hospitalised for medical reasons. Eligible patients will be randomised 1:1 to receive structured, non-pharmacological care delivered by students of medicine, psychology and nursing, together with standard medical treatment or standard medical care alone. The protocol of interventions has been designed to cover nine main risk factors for delirium, with the scope of multidisciplinary interventions being individualised and tailored. The protocol will be aimed at immobilisation, vision and hearing impairment, cognitive impairment and disorientation, stress and anxiety, sleep-wake cycle disturbances, dehydration and malnutrition, and pain. A structured evaluation of patients' cognition, mood, anxiety and functional performance is planned to be carried out twice, on the day of group allocation and at discharge; structured screening assessment for delirium will be conducted daily using the Confusion Assessment Method. The primary outcome will be the incidence of delirium in hospital; secondary outcomes will be in-hospital changes in cognition, mood and anxiety, and functional status, occurrence of falls and death.Delirium prevention programmes are being introduced worldwide. A particular novelty of our project, however, is that invitations for voluntary work with older patients at risk for delirium will be addressed to medical students. With the use of the service learning method, the students will shape their attitudes, increase their knowledge and understanding of hospital care, and master competencies to work within interdisciplinary teams, which establishes the originality and practicality of the project.Polish Science Database, 317484 . Registered on 23 October 2016.

SUBMITTER: Piotrowicz K

PROVIDER: S-EPMC6092850 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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The "Wholesome Contact" non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial.

Piotrowicz Karolina K Rewiuk Krzysztof K Górski Stanisław S Kałwak Weronika W Wizner Barbara B Pac Agnieszka A Nowakowski Michał M Grodzicki Tomasz T

Trials 20180814 1

<h4>Background</h4>In hospital settings, delirium affects as many as 50% of older patients, aggravating their symptoms and worsening their condition, and therefore increasing the risk of in-hospital complications and death. The aim of this study is to assess the efficacy of structured, non-pharmacological care, delivered to older hospitalised patients by trained volunteers (students of medical fields), on the reduction of incidence of adverse health-related outcomes.<h4>Methods/design</h4>This t ...[more]

PMID: 30107819

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Project description:BackgroundIt is estimated that around 30% of breast cancers in post-menopausal women are related to lifestyle. The breast cancer-pooling project demonstrated that sustained weight loss of 2 to 4.5 kg is associated with an 18% lower risk of breast cancer, highlighting the importance of small changes in body weight. Our study aimed to assess the effectiveness a volunteer-delivered, community based, weight management programme (ActWELL) for women with a BMI > 25 kg/m2 attending NHS Scotland Breast Screening clinics.MethodsA multicentre, 1:1 parallel group, randomised controlled trial was undertaken in 560 women aged 50 to 70 years with BMI > 25 kg/m2. On completion of baseline measures, all participants received a breast cancer prevention leaflet. Intervention group participants received the ActWELL intervention which focussed on personalised diet advice and pedometer walking plans. The programme was delivered in leisure centres by (the charity) Breast Cancer Now volunteer coaches. Primary outcomes were changes between groups at 12 months in body weight (kg) and physical activity (accelerometer measured step count).ResultsTwo hundred seventy-nine women were allocated to the intervention group and 281 to the comparison group. Twelve-month data were available from 240 (81%) intervention and 227 (85%) comparison group participants. Coaches delivered 523 coaching sessions and 1915 support calls to 279 intervention participants. Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group. The adjusted mean difference was - 1.3 kg (95% CI - 2.2 to - 0.4, P = 0.003). The odds ratio for losing 5% weight was 2.20 (95% CI 1.4 to 3.4, p = 0.0005) in favour of the intervention. The adjusted mean difference in step counts between groups was 483 steps/day (95% CI - 635 to 1602) (NS).ConclusionsA community weight management intervention initiated at breast screening clinics and delivered by volunteer coaches doubled the likelihood of clinically significant weight loss at 12 months (compared with usual care) offering significant potential to decrease breast cancer risk.Trial registrationDatabase of registration: ISCRTN. Registration number: 11057518 . Date trial registered:21.07.2017. Date of enrolment of first participant: 01.09.2017.

Project description:IntroductionDelirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group.Methods and analysisThe study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial.Ethics and disseminationEthical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies.Trial registration numberACTRN12617001070325; Pre-results.

Project description:PurposeTo compare the effects of prevention interventions on delirium occurrence in critically ill adults.MethodsMEDLINE, Embase, PsychINFO, CINAHL, Web of Science, Cochrane Library, Prospero, and WHO international clinical trial registry were searched from inception to April 8, 2021. Randomized controlled trials of pharmacological, sedation, non-pharmacological, and multi-component interventions enrolling adult critically ill patients were included. We performed conventional pairwise meta-analyses, NMA within Bayesian random effects modeling, and determined surface under the cumulative ranking curve values and mean rank. Reviewer pairs independently extracted data, assessed bias using Cochrane Risk of Bias tool and evidence certainty with GRADE. The primary outcome was delirium occurrence; secondary outcomes were durations of delirium and mechanical ventilation, length of stay, mortality, and adverse effects.ResultsEighty trials met eligibility criteria: 67.5% pharmacological, 31.3% non-pharmacological and 1.2% mixed pharmacological and non-pharmacological interventions. For delirium occurrence, 11 pharmacological interventions (38 trials, N = 11,993) connected to the evidence network. Compared to placebo, only dexmedetomidine (21/22 alpha2 agonist trials were dexmedetomidine) probably reduces delirium occurrence (odds ratio (OR) 0.43, 95% Credible Interval (CrI) 0.21-0.85; moderate certainty). Compared to benzodiazepines, dexmedetomidine (OR 0.21, 95% CrI 0.08-0.51; low certainty), sedation interruption (OR 0.21, 95% CrI 0.06-0.69; very low certainty), opioid plus benzodiazepine (OR 0.27, 95% CrI 0.10-0.76; very low certainty), and protocolized sedation (OR 0.27, 95% CrI 0.09-0.80; very low certainty) may reduce delirium occurrence but the evidence is very uncertain. Dexmedetomidine probably reduces ICU length of stay compared to placebo (Ratio of Means (RoM) 0.78, CrI 0.64-0.95; moderate certainty) and compared to antipsychotics (RoM 0.76, CrI 0.61-0.98; low certainty). Sedative interruption, protocolized sedation and opioids may reduce hospital length of stay compared to placebo, but the evidence is very uncertain. No intervention influenced mechanical ventilation duration, mortality, or arrhythmia. Single and multi-component non-pharmacological interventions did not connect to any evidence networks to allow for ranking and comparisons as planned; pairwise comparisons did not detect differences compared to standard care.ConclusionCompared to placebo and benzodiazepines, we found dexmedetomidine likely reduced the occurrence of delirium in critically ill adults. Compared to benzodiazepines, sedation-minimization strategies may also reduce delirium occurrence, but the evidence is uncertain.

Project description:BackgroundThe Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing.Methods/designCommunity-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4-9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals.DiscussionACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere.Trial registrationISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

Dataset Information

The "Wholesome Contact" non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial.

Publications

The "Wholesome Contact" non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial.

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