scholarly journals Feasibility and acceptability of suicide prevention therapy on acute psychiatric wards: randomised controlled trial

BJPsych Open ◽  
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Gillian Haddock ◽  
Daniel Pratt ◽  
Patricia A. Gooding ◽  
Sarah Peters ◽  
Richard Emsley ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Suicide Prevention ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Prevention Therapy ◽  
Health And Social Care ◽  
Acute Psychiatric Wards ◽  
Randomised Controlled ◽  
The Impact

BackgroundSuicidal behaviour is common in acute psychiatric wards resulting in distress, and burden for patients, carers and society. Although psychological therapies for suicidal behaviour are effective in out-patient settings, there is little research on their effectiveness for in-patients who are suicidal.AimsOur primary objective was to determine whether cognitive–behavioural suicide prevention therapy (CBSP) was feasible and acceptable, compared with treatment as usual (TAU) for in-patients who are suicidal. Secondary aims were to assess the impact of CBSP on suicidal thinking, behaviours, functioning, quality of life, service use, cost-effectiveness and psychological factors associated with suicide.MethodA single-blind pilot randomised controlled trial comparing TAU to TAU plus CBSP in in-patients in acute psychiatric wards who are suicidal (the Inpatient Suicide Intervention and Therapy Evaluation (INSITE) trial, trial registration: ISRCTN17890126). The intervention consisted of TAU plus up to 20 CBSP sessions, over 6 months continuing in the community following discharge. Participants were assessed at baseline and at 6 weeks and 6 months post-baseline.ResultsA total of 51 individuals were randomised (27 to TAU, 24 to TAU plus CBSP) of whom 37 were followed up at 6 months (19 in TAU, 18 in TAU plus CBSP). Engagement, attendance, safety and user feedback indicated that the addition of CBSP to TAU for in-patients who are acutely suicidal was feasible and acceptable while on in-patient wards and following discharge. Economic analysis suggests the intervention could be cost-effective.DiscussionPsychological therapy can be delivered safely to patients who are suicidal although modifications are required for this setting. Findings indicate a larger, definitive trial should be conducted.Declaration of interestThe trial was hosted by Greater Manchester Mental health NHS Trust (formerly, Manchester Mental Health and Social Care NHS Trust). The authors are affiliated to the University of Manchester, Greater Manchester Mental Health Foundation Trust, Lancashire Care NHS Foundation trust and the Manchester Academic Health Sciences Centre. Y.A. is a trustee for a North-West England branch of the charity Mind.

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background : Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods : The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days, four and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion : This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation. Trial registration : ClinicalTrials.gov, NCT03739515; registered on 12 th November 2018. Protocol version 1. URL: https://clinicaltrials.gov/ct2/show/NCT03739515

scholarly journals The Effectiveness of a Media-Based Intervention Promoting Help-Seeking for Mental Health Difficulties By Australian Men: Study Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
ANGELA NICHOLAS ◽  
Simone Scotti Requena ◽  
Maria Ftanou ◽  
Simon Rice ◽  
Justine Fletcher ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
Media Campaigns ◽  
Mental Health Difficulties ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Approximately one fifth of Australian males aged 16 + experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. Methods This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for one week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. Discussion Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men’s mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives. Trial registration: anzctr.org.au: 2621001008819

scholarly journals A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog Trial

2019 ◽  
Author(s):  
Iracema Leroi ◽  
Christopher J. Armitage ◽  
Fidéline Collin ◽  
Eric Frison ◽  
Mark Hann ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Process Data ◽  
Causal Mechanisms ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
The Uk ◽  
The Impact ◽  
Insight Into

Abstract Background: Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. Methods and analysis: We will use a mixed method approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. Discussion: This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received, across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment. Trial registration number: ISRCTN17056211. Registered on 19 February 2018. http://www.isrctn.com/ISRCTN17056211

scholarly journals A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog Trial

2020 ◽  
Author(s):  
Iracema Leroi ◽  
Christopher J. Armitage ◽  
Fidéline Collin ◽  
Eric Frison ◽  
Mark Hann ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Process Data ◽  
Causal Mechanisms ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
The Uk ◽  
The Impact ◽  
Insight Into

Abstract Background: Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. Methods and analysis: We will use a mixed method approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. Discussion: This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received, across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment. Trial registration number: ISRCTN17056211. Registered on 19 February 2018. http://www.isrctn.com/ISRCTN17056211

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephan White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Model Of Care ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcomes include ED length of stay (from arrival to discharge) and incidence of inpatient admissions from the ED. Secondary outcomes include: ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation.

scholarly journals A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Older people are frequent emergency department (ED) users who present with complex issues that are linked to poorer health outcomes following the index visit, often have increased ED length of stay, and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and an improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCP teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, and clinical- and cost-effectiveness of care of older adults when compared with usual care. Methods The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30 days, and 4 and 6 months of follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; cost-effectiveness in terms of costs associated with ED-based HSCP compared with usual care; and perceptions on implementation by ED staff members. Discussion This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, and clinical- and cost-effectiveness of care for older patients. The findings of this study will provide important information on the effectiveness of this model of care for future implementation. Trial registration ClinicalTrials.gov, NCT03739515. Registered on 12 November 2018.

scholarly journals A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog Trial

2019 ◽  
Author(s):  
Iracema Leroi ◽  
Christopher J. Armitage ◽  
Fidéline Collin ◽  
Eric Frison ◽  
Mark Hann ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Process Data ◽  
Causal Mechanisms ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
The Uk ◽  
The Impact ◽  
Insight Into

Abstract Background: Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. Methods and analysis: We will use a mixed method approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. Discussion: This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received, across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment. Trial registration number: ISRCTN17056211. Registered on 19 February 2018. http://www.isrctn.com/ISRCTN17056211

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