scholarly journals Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043364
Author(s):  
Judith Watson ◽  
Elizabeth Coleman ◽  
Cath Jackson ◽  
Kerry Bell ◽  
Christina Maynard ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Control Group ◽  
Communication Education ◽  
Treatment As Usual ◽  
Active Communication ◽  
Randomised Controlled

ObjectiveTo establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.DesignRandomised controlled, open feasibility trial with embedded economic and process evaluations.SettingAudiology departments in two hospitals in two UK cities.ParticipantsTwelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.InterventionsConsenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.Secondary outcome measuresInternational Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.ResultsTwelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.ConclusionsWhile ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.Trial registration numberISRCTN28090877.

scholarly journals Randomised controlled feasibility trial of the Active Communication Education programme plus hearing aid provision versus hearing aid provision alone (ACE to HEAR): a study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021502 ◽  
Author(s):  
Nicholas J Thyer ◽  
Jude Watson ◽  
Cath Jackson ◽  
Louise Hickson ◽  
Christina Maynard ◽  
...  
Keyword(s):  
Health Service ◽  
Hearing Aids ◽  
Large Scale ◽  
Hearing Aid ◽  
Significant Others ◽  
Feasibility Trial ◽  
Communication Education ◽  
Hearing Aid Use ◽  
Active Communication ◽  
Randomised Controlled

IntroductionUp to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service.Methods and analysisThis will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews.Ethics and disseminationEthical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins.Trial registration numberISRCTN28090877.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

scholarly journals Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Treatment As Usual ◽  
Psychiatric Admissions ◽  
Bed Days ◽  
Randomised Controlled ◽  
Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

scholarly journals Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036061
Author(s):  
Jing Ma ◽  
Jian wei Zhang ◽  
Hua Li ◽  
Lian shan Zhao ◽  
Ai ying Guo ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Outcome Measures ◽  
Tai Chi ◽  
Short Form ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Cardiac Rehabilitation Programme ◽  
Tai Chi Exercise ◽  
Randomised Controlled

IntroductionPreliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.Methods and analysisWe propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.Ethics and disseminationThis study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People’s Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.Trial registration numberNCT03936504.

Rehabilitative Online Education versus Internet Discussion Group for Hearing Aid Users: A Randomized Controlled Trial

2011 ◽  
Vol 22 (05) ◽  
pp. 274-285 ◽  
Author(s):  
Elisabet Thorén ◽  
Monica Svensson ◽  
Anna Törnqvist ◽  
Gerhard Andersson ◽  
Per Carlbring ◽  
...  
Keyword(s):  
Online Education ◽  
Hearing Aids ◽  
Online Discussion ◽  
Hearing Aid ◽  
Intervention Group ◽  
Depression Scale ◽  
The Elderly ◽  
Control Group ◽  
Online Discussion Forum

Background: By using the Internet in the audiological rehabilitation process, it might be possible in a cost-effective way to include additional rehabilitation components by informing and guiding hearing aid users about such topics as communication strategies, hearing tactics, and how to handle hearing aids. Purpose: To evaluate the effectiveness of an online education program for adult experienced hearing aid users including professional guidance by an audiologist and compare it with the effects of participation in an online discussion forum without any professional contact. Research Design: A randomized controlled study with two groups of participants. Repeated measures at prestudy, immediate follow-up, and a 6 mo follow-up. Study Sample: Fifty-nine experienced hearing aid users participated in the study, ranging in age from 24 to 84 yr (mean 63.5 yr). Intervention: The intervention group (N = 29) underwent a five-week rehabilitative online education in which activities for each week included information, tasks, and assignments, and contact with a professional audiologist was included. The participants in the control group (N = 30) were referred to an online discussion forum without any audiologist contact. Data Collection and Analysis: A set of questionnaires administered online were used as outcome measures: (1) Hearing Handicap Inventory for the Elderly, (2) International Outcome Inventory for Hearing Aids, (3) Satisfaction with Amplification in Daily Life, and (4) Hospital Anxiety and Depression Scale. Results: Significant improvements measured by the Hearing Handicap Inventory for the Elderly were found in both groups of participants, and the effects were maintained at the 6 mo follow-up. The results on the Hospital Anxiety and Depression Scale showed that the participants in the intervention group showed reduced symptoms of depression immediately/6 mo after the intervention. At the 6 mo follow-up participants in the control group reported fewer symptoms of anxiety than they did before the intervention started. Conclusions: This study provides preliminary evidence that the Internet can be used to deliver education to experienced hearing aid users who report residual hearing problems such that their problems are reduced by the intervention. The study also suggests that online discussion forums could be used in rehabilitation. A combination of online professional supervised education and online informal discussions could be a promising rehabilitation tool.

scholarly journals Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017159 ◽  
Author(s):  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Laurence Moore ◽  
Mark Kelson ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Social Support ◽  
Weight Loss ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Intervention Group ◽  
Ethics Committee ◽  
Feasibility Trial ◽  
Control Group ◽  
Weight Loss Intervention ◽  
Randomised Controlled

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

scholarly journals Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

2017 ◽  
Vol 21 (35) ◽  
pp. 1-164 ◽  
Author(s):  
Mark B Gabbay ◽  
Adele Ring ◽  
Richard Byng ◽  
Pippa Anderson ◽  
Rod S Taylor ◽  
...  
Keyword(s):  
Primary Care ◽  
Outcome Measures ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Pilot Phase ◽  
Main Trial ◽  
Internal Pilot ◽  
Randomised Controlled

BackgroundDepression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research.ObjectivesThe overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems.DesignAn adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups.SettingGeneral practices in England and Wales.ParticipantsIndividuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice.InterventionsThe participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only.Main outcome measures(1) Outcomes of the pilot trial – the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes – primary – Beck Depression Inventory II; secondary – psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources – qualitative interviews were conducted with participants, clinicians and CAB advisors.ResultsOf the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months’ follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months’ follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences.ConclusionsAs a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites.Trial registrationCurrent Controlled Trials ISRCTN79705874.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 35. See the NIHR Journals Library website for further project information. Mark Gabbay and Adele Ring are part-funded by NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North West Coast and Richard Byng and Rod S Taylor, Vashti Berry and Elizabeth Shaw part-funded by NIHR CLAHRC South West Peninsula.

scholarly journals Hearing aids reduce daily-life fatigue and increase social activity: a longitudinal study

2021 ◽  
Author(s):  
Jack A Holman ◽  
Graham Naylor ◽  
Avril Drummond
Keyword(s):  
Hearing Loss ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Social Activity ◽  
Intervention Group ◽  
Activity Level ◽  
Self Report ◽  
Control Group ◽  
Activity Levels ◽  
Hearing Aid Fitting

People with hearing loss experience fatigue, and it is unknown whether this is alleviated by treatment with hearing aids. The objective of this study was to address this issue, and to investigate the possible concomitant effect of hearing-aid fitting on activity levels. An intervention group (n=53) who were due to be fitted with their first ever hearing aid(s) and a control group (n=53) who had hearing loss but no change in hearing aid status completed a battery of self-report outcome measures four times: once before fitting, and at two weeks, three months and six months post fitting. Self-report outcome measures at each assessment captured fatigue, listening effort, hearing handicap, auditory lifestyle, social participation restrictions and work, social and physical activity levels. Hearing-aid fitting led to a significant reduction in listening-related fatigue, but not general fatigue, in the intervention group compared to the control group. Additionally, social activity level increased and social participation restriction decreased significantly after hearing aid fitting in the intervention group compared to the control group. No significant interaction was found between working status and change in listening-related fatigue score. This study is the first to make longitudinal measurement of fatigue before and after first-ever hearing aid fitting and to identify an increase in social activity level after hearing aid fitting. These findings have important implications for future research and the clinical practice of hearing aid fitting.

Preparing Adolescents for Life after School (PALS) Project: A Randomised Controlled Trial of a Coaching Intervention for Young People with Acquired Brain Injury

2018 ◽  
Vol 20 (1) ◽  
pp. 1-15 ◽  
Author(s):  
Robyn L. Tate ◽  
Michelle Genders ◽  
Cheryl Soo ◽  
Ulrike Rosenkoetter ◽  
Margaret Dunn ◽  
...  
Keyword(s):  
Brain Injury ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Acquired Brain Injury ◽  
After School ◽  
Control Group ◽  
Coaching Intervention ◽  
Randomised Controlled

Introduction: Existing resources to support adolescents with acquired brain injury (ABI) in transition from school to the ‘adult world’ are variable. This study evaluated an intervention using a coaching approach to support adolescents during this transition phase.Method: The study design was a parallel-group randomised controlled trial (RCT). Participants (n= 43) aged 14–19 years were randomised to intervention (n= 21) or no-intervention control (n= 21) conditions. The intervention group received six coaching sessions over an average of 22 weeks. Outcome measures evaluated changes reported by the adolescent (satisfaction, emotional functioning and hope) and their parent (participation, behaviour and support needs).Results: Relative to baseline, there was no significant improvement for those in the intervention group in comparison to the control group on any of the outcome measures.Conclusion: The results of this RCT do not support coaching as an intervention for adolescents with ABI.

scholarly journals A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care

2020 ◽  
Vol 49 (4) ◽  
pp. 640-647
Author(s):  
John Young ◽  
John Green ◽  
Amanda Farrin ◽  
Michelle Collinson ◽  
Suzanne Hartley ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Assessment Method ◽  
System Of Care ◽  
Feasibility Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
New Onset

Abstract Objective to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design cluster randomised and controlled feasibility trial. Setting sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants patients 65 years and over admitted to participating wards during the trial period. Interventions participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

Sign in / Sign up

Export Citation Format

Share Document