Lifestyle matters randomized controlled trial of a preventive health intervention for older people: Qualitative sub study with participants and intervention facilitators

© 2020 Mountain et al. Objective: This qualitative study embedded within a randomized controlled trial was conducted to explore the acceptability, experiences of, and short-term impact of a preventive health intervention (Lifestyle Matters) from the perspectives of those who took part, and to uncover any evidence for the theorised mechanisms of action (improved participation and self efficacy) underpinning the intervention. It was also conducted to help explain the quantitative trial results. Methods: A purposive sample of 13 trial participants who had been randomized to receive the Lifestyle Matters intervention (approximately 10%) were individually qualitatively interviewed immediately following their involvement. All four intervention facilitators were also individually interviewed. Results: Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention. However, lack of adherence to the overall intervention eroded receipt of benefit. This finding complements the quantitative trial results which found that the study had failed to recruit those who considered themselves to be at risk of age-related decline. Conclusion: This form of preventive health intervention requires proactive identification of those who recognise the need to make lifestyle changes. This is difficult if reactive health and social care systems are the main referral routes. The methodological approaches taken towards the study of complex interventions requires reconsideration if potential benefits are to be accurately assessed. Clinical Trial Registration: ISRCTN67209155

The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study

Objectives To assess the long-term effect on health and well-being of the Lifestyle Matters programme. Design Qualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled trial (RCT). Setting The intervention took place at community venues within two sites in the UK. Participants A purposeful sample of 13 participants aged between 66 and 88 years from the intervention arm of the RCT were interviewed at 24 months post randomisation. Interviews aimed to understand how participants had used their time in the preceding 2 years and whether the intervention had any impact on their lifestyle choices, participation in meaningful activities and well-being. Intervention Lifestyle Matters is a 4-month occupational therapy intervention, consisting of group and individual sessions, designed to enable community living older people to make positive lifestyle choices and participate in new or neglected activities through increasing self-efficacy. Results Interviews revealed that the majority of interviewed participants were reportedly active at 24 months, with daily routines and lifestyles not changing significantly over time. All participants raised some form of benefit from attending Lifestyle Matters, including an improved perspective on life, trying new hobbies and meeting new friends. A number of intervention participants spoke of adapting to their changing circumstances, but there were significant and lasting benefits for 2 of 13 intervention participants interviewed. Conclusion The majority of those who experienced the Lifestyle Matters intervention reported minor benefits and increases in self-efficacy, but they did not perceive that it significantly improved their health and well-being. The two participants who had experienced major benefits also reported having had life-changing events, suggesting that this intervention is most effective at the time when lifestyle has to be reconsidered if mental well-being is to be sustaine

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies. This 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing.Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation. South Central-Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences. ISRCTN23800982; Pre-results

A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial

to test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial. 288 independently living adults aged 65 years or over, with normal cognition, were recruited from two UK sites between December 2011 and November 2015. lifestyle Matters is a National Institute for Health and Care Excellence recommended multi-component preventive intervention designed to improve the mental well-being of community living older people at risk of decline. It involves weekly group sessions over 4 months and one to one sessions. the primary outcome was mental well-being at 6 months (mental health (MH) dimension of the SF-36). Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness (de Jong Gierveld Loneliness Scale), assessed at 6 and 24 months. data on 262 (intervention = 136; usual care = 126) participants were analysed using intention to treat analysis. Mean SF-36 MH scores at 6 months differed by 2.3 points (95 CI: -1.3 to 5.9; P = 0.209) after adjustments. analysis shows little evidence of clinical or cost-effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote well-being in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline. ISRCTN67209155

The use of rapid review methods in health technology assessments: 3 case studies.

BACKGROUND: Rapid reviews are of increasing importance within health technology assessment due to time and resource constraints. There are many rapid review methods available although there is little guidance as to the most suitable methods. We present three case studies employing differing methods to suit the evidence base for each review and outline some issues to consider when selecting an appropriate method. METHODS: Three recently completed systematic review short reports produced for the UK National Institute for Health Research were examined. Different approaches to rapid review methods were used in the three reports which were undertaken to inform the commissioning of services within the NHS and to inform future trial design. We describe the methods used, the reasoning behind the choice of methods and explore the strengths and weaknesses of each method. RESULTS: Rapid review methods were chosen to meet the needs of the review and each review had distinctly different challenges such as heterogeneity in terms of populations, interventions, comparators and outcome measures (PICO) and/or large numbers of relevant trials. All reviews included at least 10 randomised controlled trials (RCTs), each with numerous included outcomes. For the first case study (sexual health interventions), very diverse studies in terms of PICO were included. P-values and summary information only were presented due to substantial heterogeneity between studies and outcomes measured. For the second case study (premature ejaculation treatments), there were over 100 RCTs but also several existing systematic reviews. Data for meta-analyses were extracted directly from existing systematic reviews with new RCT data added where available. For the final case study (cannabis cessation therapies), studies included a wide range of interventions and considerable variation in study populations and outcomes. A brief summary of the key findings for each study was presented and narrative synthesis used to summarise results for each pair of interventions compared. CONCLUSIONS: Rapid review methods need to be chosen to meet both the nature of the evidence base of a review and the challenges presented by the included studies. Appropriate methods should be chosen after an assessment of the evidence base

Paramedic assessment of older adults after falls, including community care referral pathway : cluster randomized trial

Study objective We aim to determine clinical and cost-effectiveness of a paramedic protocol for the care of older people who fall. Methods We undertook a cluster randomized trial in 3 UK ambulance services between March 2011 and June 2012. We included patients aged 65 years or older after an emergency call for a fall, attended by paramedics based at trial stations. Intervention paramedics could refer the patient to a community-based falls service instead of transporting the patient to the emergency department. Control paramedics provided care as usual. The primary outcome was subsequent emergency contacts or death. Results One hundred five paramedics based at 14 intervention stations attended 3,073 eligible patients; 110 paramedics based at 11 control stations attended 2,841 eligible patients. We analyzed primary outcomes for 2,391 intervention and 2,264 control patients. One third of patients made further emergency contacts or died within 1 month, and two thirds within 6 months, with no difference between groups. Subsequent 999 call rates within 6 months were lower in the intervention arm (0.0125 versus 0.0172; adjusted difference –0.0045; 95% confidence interval –0.0073 to –0.0017). Intervention paramedics referred 8% of patients (204/2,420) to falls services and left fewer patients at the scene without any ongoing care. Intervention patients reported higher satisfaction with interpersonal aspects of care. There were no other differences between groups. Mean intervention cost was $23 per patient, with no difference in overall resource use between groups at 1 or 6 months. Conclusion A clinical protocol for paramedics reduced emergency ambulance calls for patients attended for a fall safely and at modest cost

Psychological and psychosocial interventions for cannabis cessation in adults: A systematic review

Objective: Many psychological and psychosocial interventions have been developed to treat regular users of cannabis, but it is unclear which intervention(s) are the most effective. This article aims to assess the effectiveness of psychological and psychosocial interventions for cannabis cessation, and to outline priorities for future research. Methods: A systematic review of the scientific literature. Eleven databases were searched in February 2014. Results: Twenty-six RCTs were identified; the majority were considered to be at a high risk of bias. Cognitive behavioural therapy (CBT) significantly improved outcomes compared with wait-list in five studies post-treatment, maintained at 9 months in the one study with later follow-up. Studies of motivational interviewing (MI) or motivational enhancement therapy (MET) gave mixed results, with some improvements over wait-list while some comparisons were not significant. Four studies comparing CBT against MI/MET gave mixed results; longer courses of CBT provided some improvements over shorter MI. Courses of other types of therapy (social support groups and case management) gave similar improvements to CBT. Vouchers for abstinence (contingency management) gave promising results in the short-term and at follow-up. Conclusion: Studies were heterogeneous, covering a range of interventions, comparators, populations and outcomes. CBT improved short-term outcomes in a clinically dependent self-selected population of cannabis users. Brief MI improved short-term outcomes at post-treatment in a younger non-clinically dependent population. There is some evidence that CBT may be more effective than briefer MI interventions although results were mixed. Contingency management may enhance long-term outcomes in combination with CBT in clinically dependent individuals

Psychological and psychosocial interventions for cannabis cessation in adults: a systematic review short report.

BACKGROUND: Cannabis is the most commonly used illicit drug worldwide. Cannabis dependence is a recognised psychiatric diagnosis, often diagnosed via the Diagnostic and Statistical Manual of Mental Disorders criteria and the International Classification of Diseases, 10th Revision. Cannabis use is associated with an increased risk of medical and psychological problems. This systematic review evaluates the use of a wide variety of psychological and psychosocial interventions, such as motivational interviewing (MI), cognitive-behavioural therapy (CBT) and contingency management. OBJECTIVE: To systematically review the clinical effectiveness of psychological and psychosocial interventions for cannabis cessation in adults who use cannabis regularly. DATA SOURCES: Studies were identified via searches of 11 databases [MEDLINE, EMBASE, Cochrane Controlled Trials Register, Health Technology Assessment (HTA) database, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, NHS Economic Evaluation Database, PsycINFO, Web of Science Conference Proceedings Citation Index, ClinicalTrials.gov and metaRegister of Current Controlled Trials] from inception to February 2014, searching of existing reviews and reference tracking. METHODS: Randomised controlled trials (RCTs) assessing psychological or psychosocial interventions in a community setting were eligible. Risk of bias was assessed using adapted Cochrane criteria and narrative synthesis was undertaken. Outcomes included change in cannabis use, severity of cannabis dependence, motivation to change and intervention adherence. RESULTS: The review included 33 RCTs conducted in various countries (mostly the USA and Australia). General population studies: 26 studies assessed the general population of cannabis users. Across six studies, CBT (4-14 sessions) significantly improved outcomes (cannabis use, severity of dependence, cannabis problems) compared with wait list post treatment, maintained at 9 months in the one study with later follow-up. Studies of briefer MI or motivational enhancement therapy (MET) (one or two sessions) gave mixed results, with some improvements over wait list, while some comparisons were not significant. Four studies comparing CBT (6-14 sessions) with MI/MET (1-4 sessions) also gave mixed results: longer courses of CBT provided some improvements over MI. In one small study, supportive-expressive dynamic psychotherapy (16 sessions) gave significant improvements over one-session MI. Courses of other types of therapy (social support group, case management) gave similar improvements to CBT based on limited data. Limited data indicated that telephone- or internet-based interventions might be effective. Contingency management (vouchers for abstinence) gave promising results in the short term; however, at later follow-ups, vouchers in combination with CBT gave better results than vouchers or CBT alone. Psychiatric population studies: seven studies assessed psychiatric populations (schizophrenia, psychosis, bipolar disorder or major depression). CBT appeared to have little effect over treatment as usual (TAU) based on four small studies with design limitations (both groups received TAU and patients were referred). Other studies reported no significant difference between types of 10-session therapy. LIMITATIONS: Included studies were heterogeneous, covering a wide range of interventions, comparators, populations and outcomes. The majority were considered at high risk of bias. Effect sizes were reported in different formats across studies and outcomes. CONCLUSIONS: Based on the available evidence, courses of CBT and (to a lesser extent) one or two sessions of MI improved outcomes in a self-selected population of cannabis users. There was some evidence that contingency management enhanced long-term outcomes in combination with CBT. Results of CBT for cannabis cessation in psychiatric populations were less promising, but may have been affected by provision of TAU in both groups and the referred populations. Future research should focus on the number of CBT/MI sessions required and potential clinical effectiveness and cost-effectiveness of shorter interventions. CBT plus contingency management and mutual aid therapies warrant further study. Studies should consider potential effects of recruitment methods and include inactive control groups and long-term follow-up. TAU arms in psychiatric population studies should aim not to confound the study intervention

Psychological and psychosocial interventions for cannabis cessation in adults: A systematic review.

Objective: Many psychological and psychosocial interventions have been developed to treat regular users of cannabis, but it is unclear which intervention(s) are the most effective. This article aims to assess the effectiveness of psychological and psychosocial interventions for cannabis cessation, and to outline priorities for future research. Methods: A systematic review of the scientific literature. Eleven databases were searched in February 2014. Results: Twenty-six RCTs were identified; the majority were considered to be at a high risk of bias. Cognitive behavioural therapy (CBT) significantly improved outcomes compared with wait-list in five studies post-treatment, maintained at 9 months in the one study with later follow-up. Studies of motivational interviewing (MI) or motivational enhancement therapy (MET) gave mixed results, with some improvements over wait-list while some comparisons were not significant. Four studies comparing CBT against MI/MET gave mixed results; longer courses of CBT provided some improvements over shorter MI. Courses of other types of therapy (social support groups and case management) gave similar improvements to CBT. Vouchers for abstinence (contingency management) gave promising results in the short-term and at follow-up. Conclusion: Studies were heterogeneous, covering a range of interventions, comparators, populations and outcomes. CBT improved short-term outcomes in a clinically dependent self-selected population of cannabis users. Brief MI improved short-term outcomes at post-treatment in a younger non-clinically dependent population. There is some evidence that CBT may be more effective than briefer MI interventions although results were mixed. Contingency management may enhance long-term outcomes in combination with CBT in clinically dependent individuals