Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

Background: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. Methods: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. Findings: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96–1·28). Interpretation: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. Funding: National Institute for Health Research Health Services and Delivery Research Programme

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme

QuikFix: enhanced motivational interviewing interventions for youth substance use

Purpose This paper explores the background principles, theories, and components of the QuikFix intervention for primary and comorbid substance use in young people. Design/methodology/approach QuikFix is a brief Motivational Interviewing (MI) intervention utilising cognitive-behavioural coping skills training to reduce vulnerability to substance use and comorbid mental health problems in young people. It is delivered in two to three brief sessions including an assessment. A new version, QuikFix PI (Personality Intervention) which incorporates coping skills training targeting, sensation seeking, impulsive, depressive and anxiety personality styles that may underlie primary and comorbid substance use problems is presented. Findings The original QuikFix intervention has demonstrated efficacy in young alcohol and cannabis users with comorbid depression and anxiety symptoms. The efficacy of the new personality targeted version of QuikFix is currently being tested in a large randomized controlled trial among young people with alcohol related injuries/illnesses. Future research is required to determine the efficacy of QuikFix PI in comorbid populations including those with behavioural disorders. Practical implications QuikFix interventions can be delivered via telephone or face-to-face in clinical settings for clients with primary substance use and comorbid depression and anxiety symptoms. Originality/value This paper describes a novel two to three session manualised personality targeted substance use intervention. The full original QuikFix treatment manual is available online (Hides and Carroll 2010). </jats:sec

The Quik Fix study: a randomised controlled trial of brief interventions for young people with alcohol-related injuries and illnesses accessing emergency department and crisis support care

Background: Alcohol is a major preventable cause of injury, disability and death in young people. Large numbers of young people with alcohol-related injuries and medical conditions present to hospital emergency departments (EDs). Access to brief, efficacious, accessible and cost effective treatment is an international health priority within this age group. While there is growing evidence for the efficacy of brief motivational interviewing (MI) for reducing alcohol use in young people, there is significant scope to increase its impact, and determine if it is the most efficacious and cost effective type of brief intervention available. The efficacy of personality-targeted interventions (PIs) for alcohol misuse delivered individually to young people is yet to be determined or compared to MI, despite growing evidence for school-based PIs. This study protocol describes a randomized controlled trial comparing the efficacy and cost-effectiveness of telephone-delivered MI, PI and an Assessment Feedback/Information (AF/I) only control for reducing alcohol use and related harm in young people. Methods/design: Participants will be 390 young people aged 16 to 25 years presenting to a crisis support service or ED with alcohol-related injuries and illnesses (including severe alcohol intoxication). This single blinded superiority trial randomized young people to (i) 2 sessions of MI; (ii) 2 sessions of a new PI or (iii) a 1 session AF/I only control. Participants are reassessed at 1, 3, 6 and 12 months on the primary outcomes of alcohol use and related problems and secondary outcomes of mental health symptoms, functioning, severity of problematic alcohol use, alcohol injuries, alcohol-related knowledge, coping self-efficacy to resist using alcohol, and cost effectiveness. Discussion: This study will identify the most efficacious and cost-effective telephone-delivered brief intervention for reducing alcohol misuse and related problems in young people presenting to crisis support services or EDs. We expect efficacy will be greatest for PI, followed by MI, and then AF/I at 1, 3, 6 and 12 months on the primary and secondary outcome variables. Telephone-delivered brief interventions could provide a youth-friendly, accessible, efficacious, cost-effective and easily disseminated treatment for addressing the significant public health issue of alcohol misuse and related harm in young people. Trial registration: This trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000108718

A recommended process for development and evaluation of eTools for mental health and wellbeing

Web or mobile application based interventions for mental health and wellbeing (hereafter &#039;eTools&#039;) have proliferated with the uptake of smartphones. This makes it difficult for potential users to select high quality tools to address their needs. Cognitive-behaviour therapists face similar challenges when attempting to select and recommend eTools to their clients. Robust approaches to the development and evaluation of eTools are required to address these issues. The inclusion of potential users throughout the development process optimises the acceptability, utility and perceived relevance of eTools. Subsequent testing of eTools in randomised controlled trials (RCTs) is highly desirable. However, extended delays in the release and marketing of an eTool may mean it is superseded due to technological advancements or the release of similar eTools. When the results of RCTs are not yet available, minimum requirements comprise evidence-based content and uncontrolled outcome evaluations. Reporting of adherence to development processes such as these would offer a sound basis for eTool selection by practitioners and other users

The baby steps web program for the well-being of new parents: Randomized controlled trial

Background: New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents. Objective: This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently. Methods: The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks' gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples' randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples. Results: Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time. Conclusions: Three secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby StepsWellbeing for perinatal adjustment.</p

Baby Steps - an online program promoting the wellbeing of new mothers and fathers: a study protocol

Parental well-being can be seriously impacted during the challenging perinatal period. Most research and support services focus on perinatal psychopathology, leaving a need for programs that recognize and enhance the strengths and well-being of parents. Furthermore, fathers have received minimal attention and support relative to mothers, despite experiencing perinatal distress. New parents have limited time and energy to invest in program attendance, and web-based programs provide an ideal platform for delivering perinatal well-being programs. Such programs are globally accessible, available at any time, and can be accessed anywhere with an Internet connection.This paper describes the protocol of a randomized controlled trial investigating the effects on first-time parents' perinatal well-being, comparing two versions of the online program Baby Steps.The clinical trial will randomize 240 primiparous mother-father couples to either (1) Babycare, an online information-only program providing tips on selected childcare issues, or (2) Well-being, an online interactive program including all content from the Babycare program, plus parental well-being-focused content with tools for goal-setting and problem solving. Both programs will be supported by short message service (SMS) texts at two, four, seven, and ten weeks to encourage continued use of the program. Primary outcomes will be measures of perinatal distress and quality of life. Secondary outcomes will be couple relationship satisfaction, parent self-efficacy, and social support. Cost-effectiveness will also be measured for each Baby Steps program.Participant recruitment commenced March, 2015 and continued until October, 2015. Follow-up data collection has commenced and will be completed May, 2016 with results expected in July, 2016.Perinatal distress has substantial impacts on parents and their infants, with potential to affect later childhood adjustment, relationships, and development. This study aims to test the impact of a highly accessible online program to support parental coping, and maximize the well-being of both parents. By including fathers in the program, Baby Steps has the potential to engage and support this often neglected group who can make a substantial contribution to familial well-being.Australian & New Zealand Clinical Trials Registry: ANZCTR12614001256662; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=367277 (Archived by WebCite at http://www.webcitation.org/6ibUsjFIL)