scholarly journals An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT

2020 ◽  
Vol 24 (24) ◽  
pp. 1-202
Author(s):  
Lisa Shaw ◽  
Nawaraj Bhattarai ◽  
Robin Cant ◽  
Avril Drummond ◽  
Gary A Ford ◽  
...  

Background There is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers. Objective To determine the clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS). Design A pragmatic, observer-blind, parallel-group, multicentre randomised controlled trial with embedded health economic and process evaluations. Participants were randomised (1 : 1) to receive EXTRAS or usual care. Setting Nineteen NHS study centres. Participants Patients with a new stroke who received early supported discharge and their informal carers. Interventions Five EXTRAS reviews provided by an early supported discharge team member between 1 and 18 months post early supported discharge, usually over the telephone. Reviewers assessed rehabilitation needs, with goal-setting and action-planning. Control treatment was usual care post early supported discharge. Main outcome measures The primary outcome was performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post randomisation. Secondary outcomes at 12 and 24 months included patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events. For carers, secondary outcomes included carers’ strain (Caregiver Strain Index) and experience of services. Cost-effectiveness was estimated using resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years. Results A total of 573 patients (EXTRAS, n = 285; usual care, n = 288) with 194 carers (EXTRAS, n = 103; usual care, n = 91) were randomised. Mean 24-month Nottingham Extended Activities of Daily Living Scale scores were 40.0 (standard deviation 18.1) for EXTRAS (n = 219) and 37.2 (standard deviation 18.5) for usual care (n = 231), giving an adjusted mean difference of 1.8 (95% confidence interval –0.7 to 4.2). The mean intervention group Hospital Anxiety and Depression Scale scores were not significantly different at 12 and 24 months. The intervention did not improve patient health status or carer strain. EXTRAS patients and carers reported greater satisfaction with some aspects of care. The mean cost of resource utilisation was lower in the intervention group: –£311 (95% confidence interval –£3292 to £2787), with a 68% chance of EXTRAS being cost-saving. EXTRAS was associated with 0.07 (95% confidence interval 0.01 to 0.12) additional quality-adjusted life-years. At current conventional thresholds of willingness to pay for a quality-adjusted life-year, there is a 90% chance that EXTRAS is cost-effective. Conclusions EXTRAS did not improve stroke survivors’ performance in extended activities of daily living but did improve their overall satisfaction with services. Given the impact on costs and quality-adjusted life-years, there is a high chance that EXTRAS could be considered cost-effective. Future work Further research is required to identify whether or not community-based interventions can improve performance of extended activities of daily living, and to understand the improvements in health-related quality of life and costs seen by provision of intermittent longer-term specialist review. Trial registration Current Controlled Trials ISRCTN45203373. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 24. See the NIHR Journals Library website for further project information.

Stroke ◽  
2019 ◽  
Vol 50 (12) ◽  
pp. 3561-3568 ◽  
Author(s):  
Helen Rodgers ◽  
Denise Howel ◽  
Nawaraj Bhattarai ◽  
Robin Cant ◽  
Avril Drummond ◽  
...  

Background and Purpose— There is limited evidence to guide rehabilitation to meet the longer term needs of stroke survivors. The clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS) provided following early supported discharge were determined. Methods— EXTRAS was a pragmatic parallel-group observer-blind randomized controlled trial involving 19 UK centers. Patients with stroke were individually randomized to receive EXTRAS or usual care at discharge from early supported discharge. Five EXTRAS reviews were provided by an early supported discharge team member between one and 18 months, usually by telephone. Reviews consisted of a semi-structured interview assessing progress, rehabilitation needs, and service provision, with goal setting and action planning. The primary outcome was performance in extended activities of daily living (Nottingham EADL Scale) at 24 months post-randomization. The Nottingham EADL Scale is scored 0 to 66, with higher scores indicating better performance in these activities. Cost-effectiveness was estimated using resource utilization costs and Quality Adjusted Life Years. Analyses were intention to treat. Results— Between January 9, 2013 and October 26, 2015, 573 participants were randomized (EXTRAS, n=285; usual care, n=288). Mean 24 month Nottingham EADL Scale scores were EXTRAS (n=219) 40.0 (SD 18.1) and usual care (n=231) 37.2 (SD 18.5) giving an adjusted mean difference of 1.8 (95% CI, –0.7 to 4.2). 1155/1338 (86%) of expected EXTRAS reviews were undertaken. Over 24 months, the mean cost of resource utilization was lower in the intervention group: –£311 (–$450 [95% CI, −£3292 to £2787; −$4764 to $4033]). EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]). At current conventional thresholds of willingness to pay (£20 000 [$28 940] per Quality Adjusted Life Years), there was a 90% chance that EXTRAS could be considered cost-effective. Conclusions— EXTRAS did not significantly improve stroke survivors’ performance in extended activities of daily living. However, given the impact on costs and Quality Adjusted Life Years, EXTRAS may be an affordable addition to improve stroke care. Clinical Trial Registration— URL: www.isrctn.com . Unique identifier: ISRCTN45203373.


2019 ◽  
Vol 7 (15) ◽  
pp. 1-114 ◽  
Author(s):  
Ruth F Hunter ◽  
Aisling Gough ◽  
Jennifer M Murray ◽  
Jianjun Tang ◽  
Sarah F Brennan ◽  
...  

Background Increasing physical activity in the workplace can provide physical and mental health benefits for employees and economic benefits for the employer through reduced absenteeism and increased productivity. However, there is limited evidence on effective behaviour change interventions in workplace settings that led to maintained physical activity. This study aimed to address this gap and contribute to the evidence base for effective and cost-effective workplace interventions. Objectives To determine the effectiveness and cost-effectiveness of the Physical Activity Loyalty scheme, a multicomponent intervention based on concepts similar to those that underpin a high-street loyalty card, which was aimed at encouraging habitual physical activity behaviour and maintaining increases in mean number of steps per day. Design A cluster randomised controlled trial with an embedded economic evaluation, behavioural economic experiments, mediation analyses and process evaluation. Setting Office-based employees from public sector organisations in Belfast and Lisburn city centres in Northern Ireland. Participants A total of 853 participants [mean age 43.6 years (standard deviation 9.6 years); 71% of participants were female] were randomly allocated by cluster to either the intervention group or the (waiting list) control group. Intervention The 6-month intervention consisted of financial incentives (retail vouchers), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of the workplaces allowed participants to monitor their accumulated minutes of physical activity. Main outcome measures The primary outcome was mean number of steps per day recorded using a sealed pedometer (Yamax Digiwalker CW-701; Yamax, Tasley, UK) worn on the waist for 7 consecutive days and at 6 and 12 months post intervention. Secondary outcomes included health, mental well-being, quality of life, work absenteeism and presenteeism, and the use of health-care resources. Results The mean number of steps per day were significantly lower for the intervention group than the control group [6990 mean number of steps per day (standard deviation 3078) vs. 7576 mean number of steps per day (standard deviation 3345), respectively], with an adjusted mean difference of –336 steps (95% confidence interval –612 to –60 steps; p = 0.02) at 6 months post baseline, but not significantly lower at 12 months post baseline. There was a small but significant enhancement of mental well-being in the intervention group (difference between groups for the Warwick–Edinburgh Mental Wellbeing Scale of 1.34 points, 95% confidence interval 0.48 to 2.20 points), but not for the other secondary outcomes. An economic evaluation suggested that, overall, the scheme was not cost-effective compared with no intervention. The intervention was £25.85 (95% confidence interval –£29.89 to £81.60) more costly per participant than no intervention and had no effect on quality-adjusted life-years (incremental quality-adjusted life-years –0.0000891, 95% confidence interval –0.008 to 0.008). Limitations Significant restructuring of participating organisations during the study resulted in lower than anticipated recruitment and retention rates. Technical issues affected intervention fidelity. Conclusions Overall, assignment to the intervention group resulted in a small but significant decline in the mean pedometer-measured steps per day at 6 months relative to baseline, compared with the waiting list control group. The Physical Activity Loyalty scheme was deemed not to be cost-effective compared with no intervention, primarily because no additional quality-adjusted life-years were gained through the intervention. Research to better understand the mechanisms of physical activity behaviour change maintenance will help the design of future interventions. Trial registration Current Controlled Trials ISRCTN17975376. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 15. See the NIHR Journals Library website for further project information.


2020 ◽  
Vol 34 (7) ◽  
pp. 934-945 ◽  
Author(s):  
Mohamed El Alili ◽  
Claudia S.E.W Schuurhuizen ◽  
Annemarie M.J. Braamse ◽  
Aartjan T.F. Beekman ◽  
Mecheline H. van der Linden ◽  
...  

Background: Psychological distress is highly prevalent among patients with metastatic colorectal cancer. Aims: To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care. Design: Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included. Setting: Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands. Methods: Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results. Results: Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: –0.058; 95% confidence interval: –0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: –0.015 to 0.099), and societal costs (mean difference: –1152; 95% confidence interval: –5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. Conclusion: The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.


2021 ◽  
Vol 25 (19) ◽  
pp. 1-156
Author(s):  
Rebecca Gathercole ◽  
Rosie Bradley ◽  
Emma Harper ◽  
Lucy Davies ◽  
Lynn Pank ◽  
...  

Background Assistive technology and telecare have been promoted to manage the risks associated with independent living for people with dementia, but there is limited evidence of their effectiveness. Objectives This trial aimed to establish whether or not assistive technology and telecare assessments and interventions extend the time that people with dementia can continue to live independently at home and whether or not they are cost-effective. Caregiver burden, the quality of life of caregivers and of people with dementia and whether or not assistive technology and telecare reduce safety risks were also investigated. Design This was a pragmatic, randomised controlled trial. Blinding was not undertaken as it was not feasible to do so. All consenting participants were included in an intention-to-treat analysis. Setting This trial was set in 12 councils in England with adult social services responsibilities. Participants Participants were people with dementia living in the community who had an identified need that might benefit from assistive technology and telecare. Interventions Participants were randomly assigned to receive either assistive technology and telecare recommended by a health or social care professional to meet their assessed needs (a full assistive technology and telecare package) or a pendant alarm, non-monitored smoke and carbon monoxide detectors and a key safe (a basic assistive technology and telecare package). Main outcome measures The primary outcomes were time to admission to care and cost-effectiveness. Secondary outcomes assessed caregivers using the 10-item Center for Epidemiological Studies Depression Scale, the State–Trait Anxiety Inventory 6-item scale and the Zarit Burden Interview. Results Of 495 participants, 248 were randomised to receive full assistive technology and telecare and 247 received the limited control. Comparing the assistive technology and telecare group with the control group, the hazard ratio for institutionalisation was 0.76 (95% confidence interval 0.58 to 1.01; p = 0.054). After adjusting for an imbalance in the baseline activities of daily living score between trial arms, the hazard ratio was 0.84 (95% confidence interval 0.63 to 1.12; p = 0.20). At 104 weeks, there were no significant differences between groups in health and social care resource use costs (intervention group – control group difference: mean –£909, 95% confidence interval –£5336 to £3345) or in societal costs (intervention group – control group difference: mean –£3545; 95% confidence interval –£13,914 to £6581). At 104 weeks, based on quality-adjusted life-years derived from the participant-rated EuroQol-5 Dimensions questionnaire, the intervention group had 0.105 (95% confidence interval –0.204 to –0.007) fewer quality-adjusted life-years than the control group. The number of quality-adjusted life-years derived from the proxy-rated EuroQol-5 Dimensions questionnaire did not differ between groups. Caregiver outcomes did not differ between groups over 24 weeks. Limitations Compliance with the assigned trial arm was variable, as was the quality of assistive technology and telecare needs assessments. Attrition from assessments led to data loss additional to that attributable to care home admission and censoring events. Conclusions A full package of assistive technology and telecare did not increase the length of time that participants with dementia remained in the community, and nor did it decrease caregiver burden, depression or anxiety, relative to a basic package of assistive technology and telecare. Use of the full assistive technology and telecare package did not increase participants’ health and social care or societal costs. Quality-adjusted life-years based on participants’ EuroQol-5 Dimensions questionnaire responses were reduced in the intervention group compared with the control group; groups did not differ in the number of quality-adjusted life-years based on the proxy-rated EuroQol-5 Dimensions questionnaire. Future work Future work could examine whether or not improved assessment that is more personalised to an individual is beneficial. Trial registration Current Controlled Trials ISRCTN86537017. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 19. See the NIHR Journals Library website for further project information.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
K. Auvinen ◽  
A. Voutilainen ◽  
J. Jyrkkä ◽  
E. Lönnroos ◽  
P. Mäntyselkä

Abstract Background Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients. Methods The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D. Results Home care patients (n = 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p = 0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group. Conclusions In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients. Trial registration The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812. First registration, 26 March 2015. Retrospectively registered.


2020 ◽  
Author(s):  
Kati Johanna Auvinen ◽  
Ari Voutilainen ◽  
Johanna Jyrkkä ◽  
Eija Lönnroos ◽  
Pekka Mäntyselkä

Abstract Background Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients.Methods The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D. Results Home care patients (n= 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 seconds worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p=0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group. Conclusions In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients. Trial registration The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812. First registration, 26 March 2015. Retrospectively registered. https://www.clinicaltrials.gov/ct2/show/NCT02398812


2021 ◽  
Vol 25 (69) ◽  
pp. 1-62
Author(s):  
Larisa Duffy ◽  
Caroline S Clarke ◽  
Gemma Lewis ◽  
Louise Marston ◽  
Nick Freemantle ◽  
...  

Background There has been a steady increase in the number of primary care patients receiving long-term maintenance antidepressant treatment, despite limited evidence of a benefit of this treatment beyond 8 months. Objective The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial investigated the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care. Design This was a Phase IV, double-blind, pragmatic, multisite, individually randomised parallel-group controlled trial, with follow-up at 6, 12, 26, 39 and 52 weeks. Participants were randomised using minimisation on centre, type of antidepressant and baseline depressive symptom score above or below the median using Clinical Interview Schedule – Revised (two categories). Statisticians were blind to allocation for the outcome analyses. Setting General practices in London, Bristol, Southampton and York. Participants Individuals aged 18–74 years who had experienced at least two episodes of depression and had been taking antidepressants for ≥ 9 months but felt well enough to consider stopping their medication. Those who met an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of depression or with other psychiatric conditions were excluded. Intervention At baseline, participants were taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg. They were randomised to either remain on their current medication or discontinue medication after a tapering period. Main outcome measures The primary outcome was the time, in weeks, to the beginning of the first depressive episode after randomisation. This was measured by a retrospective Clinical Interview Schedule – Revised that assessed the onset of a depressive episode in the previous 12 weeks, and was conducted at 12, 26, 39 and 52 weeks. The depression-related resource use was collected over 12 months from medical records and patient-completed questionnaires. Quality-adjusted life-years were calculated using the EuroQol-5 Dimensions, five-level version. Results Between 9 March 2017 and 1 March 2019, we randomised 238 participants to antidepressant continuation (the maintenance group) and 240 participants to antidepressant discontinuation (the discontinuation group). The time to relapse of depression was shorter in the discontinuation group, with a hazard ratio of 2.06 (95% confidence interval 1.56 to 2.70; p < 0.0001). By 52 weeks, relapse was experienced by 39% of those who continued antidepressants and 56% of those who discontinued antidepressants. The secondary analysis revealed that people who discontinued experienced more withdrawal symptoms than those who remained on medication, with the largest difference at 12 weeks. In the discontinuation group, 37% (95% confidence interval 28% to 45%) of participants remained on their randomised medication until the end of the trial. In total, 39% (95% confidence interval 32% to 45%) of participants in the discontinuation group returned to their original antidepressant compared with 20% (95% confidence interval 15% to 25%) of participants in maintenance group. The health economic evaluation demonstrated that participants randomised to discontinuation had worse utility scores at 3 months (–0.037, 95% confidence interval –0.059 to –0.015) and fewer quality-adjusted life-years over 12 months (–0.019, 95% confidence interval –0.035 to –0.003) than those randomised to continuation. The discontinuation pathway, besides giving worse outcomes, also cost more [extra £2.71 per patient over 12 months (95% confidence interval –£36.10 to £37.07)] than the continuation pathway, although the cost difference was not significant. Conclusions Patients who discontinue long-term maintenance antidepressants in primary care are at increased risk of relapse and withdrawal symptoms. However, a substantial proportion of patients can discontinue antidepressants without relapse. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants and improve shared decision-making. The participants may not have been representative of all people on long-term maintenance treatment and we could study only a restricted range of antidepressants and doses. Identifying patients who will not relapse if they discontinued antidepressants would be clinically important. Trial registration Current Controlled Trials ISRCTN15969819 and EudraCT 2015-004210-26. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 69. See the NIHR Journals Library website for further project information.


2021 ◽  
Author(s):  
Robin Bruyndonckx ◽  
Joke Bilcke ◽  
Alike W. van der Velden ◽  
Xiao Li ◽  
Niel Hens ◽  
...  

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