scholarly journals CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness

2017 ◽  
Vol 21 (8) ◽  
pp. 1-196 ◽  
Author(s):  
Helen Lewis ◽  
Joy Adamson ◽  
Katie Atherton ◽  
Della Bailey ◽  
Jacqueline Birtwistle ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Collaborative Care ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Subthreshold Depression ◽  
Patient Health ◽  
Randomised Controlled ◽  
Gp Care

BackgroundEfforts to reduce the burden of illness and personal suffering associated with depression in older adults have focused on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/subthreshold depression, but these patients also suffer significant impairments in their quality of life and level of functioning. There is currently no clear evidence-based guidance regarding treatment for this patient group.ObjectivesTo establish the clinical effectiveness and cost-effectiveness of a low-intensity intervention of collaborative care for primary care older adults who screened positive for subthreshold depression.DesignA pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected.SettingThirty-two general practitioner (GP) practices in the north of England.ParticipantsA total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression.InterventionsParticipants in the intervention group received a low-intensity intervention of collaborative care, which included behavioural activation delivered by a case manager for an average of six sessions over 7–8 weeks, alongside usual GP care. Control-arm participants received only usual GP care.Main outcome measuresThe primary outcome measure was a self-reported measure of depression severity, the Patient Health Questionnaire-9 items PHQ-9 score at 4 months post randomisation. Secondary outcome measures included the European Quality of Life-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder seven-item scale, Connor–Davidson Resilience Scale two-item version, a medication questionnaire and objective data. Participants were followed up for 12 months.ResultsIn total, 705 participants were randomised (collaborative caren = 344, usual caren = 361), with 586 participants (83%; collaborative care 76%, usual care 90%) followed up at 4 months and 519 participants (74%; collaborative care 68%, usual care 79%) followed up at 12 months. Attrition was markedly greater in the collaborative care arm. Model estimates at the primary end point of 4 months revealed a statistically significant effect in favour of collaborative care compared with usual care [mean difference 1.31 score points, 95% confidence interval (CI) 0.67 to 1.95 score points;p < 0.001]. The difference equates to a standard effect size of 0.30, for which the trial was powered. Treatment differences measured by the PHQ-9 were maintained at 12 months’ follow-up (mean difference 1.33 score points, 95% CI 0.55 to 2.10 score points;p = 0.001). Base-case cost-effectiveness analysis found that the incremental cost-effectiveness ratio was £9633 per quality-adjusted life-year (QALY). On average, participants allocated to collaborative care displayed significantly higher QALYs than those allocated to the control group (annual difference in adjusted QALYs of 0.044, 95% bias-corrected CI 0.015 to 0.072;p = 0.003).ConclusionsCollaborative care has been shown to be clinically effective and cost-effective for older adults with subthreshold depression and to reduce the proportion of people who go on to develop case-level depression at 12 months. This intervention could feasibly be delivered in the NHS at an acceptable cost–benefit ratio. Important future work would include investigating the longer-term effect of collaborative care on the CASPER population, which could be conducted by introducing an extension to follow-up, and investigating the impact of collaborative care on managing multimorbidities in people with subthreshold depression.Trial registrationCurrent Controlled Trials ISRCTN02202951.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. 8. See the NIHR Journals Library website for further project information.

scholarly journals CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness

2017 ◽  
Vol 21 (67) ◽  
pp. 1-252 ◽  
Author(s):  
Katharine Bosanquet ◽  
Joy Adamson ◽  
Katie Atherton ◽  
Della Bailey ◽  
Catherine Baxter ◽  
...  
Keyword(s):  
Usual Care ◽  
Collaborative Care ◽  
Social Care ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Depression Severity ◽  
Major Depressive ◽  
Patient Health ◽  
Randomised Controlled ◽  
Gp Care

BackgroundDepression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management.ObjectivesTo establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care.DesignA pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible.SettingSixty-nine general practices in the north of England.ParticipantsA total of 485 participants aged ≥ 65 years with major depressive disorder.InterventionsA low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7–8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care.Main outcome measuresThe primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor–Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months.ResultsIn total, 485 participants were randomised (collaborative care,n = 249; usual care,n = 236), with 390 participants (80%: collaborative care, 75%; usual care, 86%) followed up at 4 months, 358 participants (74%: collaborative care, 70%; usual care, 78%) followed up at 12 months and 344 participants (71%: collaborative care, 67%; usual care, 75%) followed up at 18 months. A total of 415 participants were included in primary analysis (collaborative care,n = 198; usual care,n = 217), which revealed a statistically significant effect in favour of collaborative care at the primary end point at 4 months [8.98 vs. 10.90 score points, mean difference 1.92 score points, 95% confidence interval (CI) 0.85 to 2.99 score points;p < 0.001], equivalent to a standard effect size of 0.34. However, treatment differences were not maintained in the longer term (at 12 months: 0.19 score points, 95% CI –0.92 to 1.29 score points;p = 0.741; at 18 months: < 0.01 score points, 95% CI –1.12 to 1.12 score points;p = 0.997). The study recorded details of all serious adverse events (SAEs), which consisted of ‘unscheduled hospitalisation’, ‘other medically important condition’ and ‘death’. No SAEs were related to the intervention. Collaborative care showed a small but non-significant increase in quality-adjusted life-years (QALYs) over the 18-month period, with a higher cost. Overall, the mean cost per incremental QALY for collaborative care compared with usual care was £26,016; however, for participants attending six or more sessions, collaborative care appears to represent better value for money (£9876/QALY).LimitationsStudy limitations are identified at different stages: design (blinding unfeasible, potential contamination), process (relatively low overall consent rate, differential attrition/retention rates) and analysis (no baseline health-care resource cost or secondary/social care data).ConclusionCollaborative care was effective for older people with case-level depression across a range of outcomes in the short term though the reduction in depression severity was not maintained over the longer term of 12 or 18 months. Participants who received six or more sessions of collaborative care did benefit substantially more than those who received fewer treatment sessions but this difference was not statistically significant.Future work recommendationsRecommendations for future research include investigating the longer-term effect of the intervention. Depression is a recurrent disorder and it would be useful to assess its impact on relapse and the prevention of future case-level depression.Trial registrationCurrent Controlled Trials ISRCTN45842879.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. 67. See the NIHR Journals Library website for further project information.

scholarly journals Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial

2016 ◽  
Vol 20 (14) ◽  
pp. 1-192 ◽  
Author(s):  
David A Richards ◽  
Peter Bower ◽  
Carolyn Chew-Graham ◽  
Linda Gask ◽  
Karina Lovell ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Collaborative Care ◽  
Service Use ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Cluster Randomised Controlled Trial ◽  
Randomised Controlled

BackgroundCollaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness.ObjectiveTo determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression.DesignCluster randomised controlled trial.SettingUK primary care practices (n = 51) in three UK primary care districts.ParticipantsA total of 581 adults aged ≥ 18 years in general practice with a currentInternational Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment.InterventionsCollaborative care: 14 weeks of 6–12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice.Main outcome measuresBlinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months.ResultsIn total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31;p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64;p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI –0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI –£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator.ConclusionsCollaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se.Trial registrationCurrent Controlled Trials ISRCTN32829227.FundingThis project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership.

scholarly journals Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.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. 24. See the NIHR Journals Library website for further project information.

scholarly journals A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial

2015 ◽  
Vol 19 (101) ◽  
pp. 1-174 ◽  
Author(s):  
Elizabeth Littlewood ◽  
Ana Duarte ◽  
Catherine Hewitt ◽  
Sarah Knowles ◽  
Stephen Palmer ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
Computerised Cognitive Behaviour Therapy ◽  
Randomised Controlled ◽  
Gp Care

BackgroundComputerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term.ObjectivesTo compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues®; Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users.DesignA pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation.SettingPrimary care in England.ParticipantsAdults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9).InterventionsParticipants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care.Main outcome measuresThe primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability of cCBT and experiences of users.ResultsClinical effectiveness:210 patients were randomised to Beating the Blues, 242 patients were randomised to MoodGYM and 239 patients were randomised to usual GP care (total 691). There was no difference in the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care,p = 0.96; and MoodGYM versus usual GP care,p = 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34;p = 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs.Cost-effectiveness:cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone.Qualitative evaluation:participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement.ConclusionsThe benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to routine primary care were minimal, and uptake of this mode of therapy was relatively low. There remains a clinical and economic need for effective low-intensity psychological treatments for depression with improved patient engagement.Trial registrationThis trial is registered as ISRCTN91947481.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

TeleClinical Care: A randomised controlled trial of a smartphone-based model of care to support cardiac patients transitioning from hospital to the community (Preprint)

2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
James McVeigh ◽  
Andrew Mamo ◽  
Joseph Magdy ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Medication Adherence ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Smartphone App ◽  
Model Of Care ◽  
Intervention Cost ◽  
Randomised Controlled

BACKGROUND This is the first randomised controlled trial (RCT) of a mobile health intervention that combines telemonitoring and educational components for both acute coronary syndrome (ACS) and heart failure (HF) inpatients to prevent readmission. OBJECTIVE Objective: To evaluate the feasibility, efficacy and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care – TCC) plus usual care in patients being discharged from hospital after an ACS or HF admission, in comparison to usual care alone. METHODS Methods: In this pilot, 2-centre RCT, a smartphone app-based model of care (TeleClinical Care – TCC) was applied at discharge. The primary endpoint was the incidence of unplanned 30-day readmissions. Secondary endpoints included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure and physical activity daily, plus usual care. The devices automatically transmitted recordings to the patient’s smartphone and then subsequently to a central server. Abnormal readings were flagged by email to a monitoring team. Control participants received usual care. RESULTS Results: 164 hospital inpatients were randomised at the time of discharge (TCC n=81, control n = 83, mean age 61.5 years, 79% male, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P = .97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 vs. 41 readmissions, P = 0.015), including cardiac readmissions (11 vs. 25, P = .025), and higher rates of cardiac rehabilitation completion (39% vs. 18%, P = .025) and medication adherence (75% vs. 50%, P = .002). The average usability rating of the app was 4.5/5. The intervention cost AUD $6,028 per cardiac readmission saved. When modelled in a mainstream clinical setting, however, enrolment of 237 patients was projected to have the same healthcare expenditure compared to usual care, and enrolment of 500 patients was projected to save approximately AUD $100,000. CONCLUSIONS Conclusion: TCC was feasible and safe for ACS and HF inpatients. The incidence of 30-day readmissions was similar, however long-term benefits were demonstrated including fewer total readmissions over 6 months, improved medication adherence and improved cardiac rehabilitation completion. CLINICALTRIAL The study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618001547235).

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 Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial

2021 ◽  
pp. 096452842110557
Author(s):  
Trygve Skonnord ◽  
Arne Fetveit ◽  
Holgeir Skjeie ◽  
Mette Brekke ◽  
Margreth Grotle ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Effectiveness Analysis ◽  
Randomised Controlled ◽  
Care Costs

Objective: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). Methods: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. Results: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. Conclusion: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. Trial registration number: NCT01439412 (ClinicalTrials.gov).

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