A feasibility study and pilot study to establish methods for assessing the acceptability, and clinical and cost-effectiveness of enhanced psychological care in cardiac rehabilitation services for patients with new onset depression compared with usual care.

2014 ◽  
Author(s):  
Suzanne Richards
Keyword(s):  
Cost Effectiveness ◽  
Pilot Study ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Feasibility Study ◽  
Rehabilitation Services ◽  
Psychological Care ◽  
New Onset

scholarly journals Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT

2018 ◽  
Vol 22 (30) ◽  
pp. 1-220 ◽  
Author(s):  
Suzanne H Richards ◽  
John L Campbell ◽  
Christopher Dickens ◽  
Rob Anderson ◽  
Manish Gandhi ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Feasibility Study ◽  
Health Technology ◽  
Future Research ◽  
Rehabilitation Services ◽  
Psychological Care ◽  
Mortality And Morbidity ◽  
Pilot Rct ◽  
New Onset

BackgroundAround 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy.Objective(s)To examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation.DesignA two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study.SettingUK comprehensive cardiac rehabilitation teams.ParticipantsAdults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded.InterventionsThe EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care.Main outcome measuresMeasures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses’ views and experiences.ResultsBetween September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. Of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. Of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care.LimitationsBoth the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses.ConclusionsCardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection.Future researchConsideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services.Trial registrationCurrent Controlled Trials ISRCTN34701576.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. 22, No. 30. See the NIHR Journals Library website for further project information.

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 Development and refinement of a complex intervention within cardiac rehabilitation services: experiences from the CADENCE feasibility study

2017 ◽  
Vol 3 (1) ◽  
Author(s):  
Rachel Winder ◽  
Suzanne H. Richards ◽  
John L. Campbell ◽  
David A. Richards ◽  
Chris Dickens ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Feasibility Study ◽  
Complex Intervention ◽  
Rehabilitation Services

Community or patient preferences for cost-effectiveness of cardiac rehabilitation: does it matter?

2008 ◽  
Vol 15 (5) ◽  
pp. 608-615 ◽  
Author(s):  
Neil Oldridge ◽  
William Furlong ◽  
Anthony Perkins ◽  
David Feeny ◽  
George W. Torrance
Keyword(s):  
Cost Effectiveness ◽  
Cardiac Rehabilitation ◽  
Incremental Cost ◽  
Usual Care ◽  
Randomized Trial ◽  
Patient Preferences ◽  
Secondary Analysis ◽  
Cost Effective ◽  
Economic Evaluations ◽  
Life Years

Background Few healthcare economic evaluations, and none in cardiac rehabilitation, report results based on both community and patient preferences for health outcomes. We published the results of a randomized trial of cardiac rehabilitation after myocardial infarction in 1994 in which preferences were measured using both perspectives but only patient preferences were reported. This secondary analysis uses both types of preference measurements. Methods We collected community Quality of Well-Being (QWB) and patient Time Trade-off (TTO) preference scores from 188 patients (rehabilitation, n = 93; usual care, n = 95) on entry into the trial, at 2 months (end of the intervention) and again at 4, 8, and 12 months. Mean preference scores over the 12-month follow-up study period, estimates of quality-adjusted life years (QALYs) gained per patient, incremental cost-effectiveness ratios [costs inflated to 2006 US dollars] and probabilities of the cost-effectiveness of rehabilitation for costs per QALY up to US$100 000 are reported. Results Mean QWB preference scores were lower ( P < 0.01) than the corresponding mean TTO preference scores at each assessment point. The 12-month changes in mean QWB and TTO preference scores were large and positive ( P < 0.001) with rehabilitation patients gaining a mean of 0.011 (95% confidence interval, –0.030 to +0.052) more QWB-derived QALYs, and 0.040 (–0.026, 0.107) more TTO-derived QALYs, per patient than usual care patients. The incremental cost-effectiveness ratio for QWB-derived QALYs was estimated at $60270/QALY (about €50 600/QALY) and at $16580/QALY (about €13 900/QALY) with TTO-derived QALYs. With a willingness to spend $100 000/QALY, the probability of rehabilitation being cost-effective is 0.58 for QWB-derived QALYs and 0.83 for TTO-derived QALYs. Conclusion This secondary analysis of data from a randomized trial indicates that cardiac rehabilitation is cost-effective from a community perspective and highly cost-effective from the perspective of patients.

scholarly journals The cost effectiveness of REACH-HF and home-based cardiac rehabilitation compared with the usual medical care for heart failure with reduced ejection fraction: A decision model-based analysis

2019 ◽  
Vol 26 (12) ◽  
pp. 1252-1261 ◽  
Author(s):  
Rod S Taylor ◽  
Susannah Sadler ◽  
Hasnain M Dalal ◽  
Fiona C Warren ◽  
Kate Jolly ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cost Effectiveness ◽  
Ejection Fraction ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Lifetime Horizon ◽  
Reduced Ejection Fraction ◽  
Home Based

Background The REACH-HF (Rehabilitation EnAblement in CHronic Heart Failure) trial found that the REACH-HF home-based cardiac rehabilitation intervention resulted in a clinically meaningful improvement in disease-specific health-related quality of life in patients with reduced ejection fraction heart failure (HFrEF). The aims of this study were to assess the long-term cost-effectiveness of the addition of REACH-HF intervention or home-based cardiac rehabilitation to usual care compared with usual care alone in patients with HFrEF. Design and methods A Markov model was developed using a patient lifetime horizon and integrating evidence from the REACH-HF trial, a systematic review/meta-analysis of randomised trials, estimates of mortality and hospital admission and UK costs at 2015/2016 prices. Taking a UK National Health and Personal Social Services perspective we report the incremental cost per quality-adjusted life-year (QALY) gained, assessing uncertainty using probabilistic and deterministic sensitivity analyses. Results In base case analysis, the REACH-HF intervention was associated with per patient mean QALY gain of 0.23 and an increased mean cost of £400 compared with usual care, resulting in a cost per QALY gained of £1720. Probabilistic sensitivity analysis indicated a 78% probability that REACH-HF is cost effective versus usual care at a threshold of £20,000 per QALY gained. Results were similar for home-based cardiac rehabilitation versus usual care. Sensitivity analyses indicate the findings to be robust to changes in model assumptions and parameters. Conclusions Our cost-utility analyses indicate that the addition of the REACH-HF intervention and home-based cardiac rehabilitation programmes are likely to be cost-effective treatment options versus usual care alone in patients with HFrEF.

scholarly journals Implementation of Person-Centered Care: A Feasibility Study Using the WE-CARE Roadmap

2021 ◽  
Vol 18 (5) ◽  
pp. 2205
Author(s):  
Roman A. Lewandowski ◽  
Jędrzej B. Lewandowski ◽  
Inger Ekman ◽  
Karl Swedberg ◽  
Jan Törnell ◽  
...  
Keyword(s):  
Pilot Study ◽  
Feasibility Study ◽  
Health Care Professionals ◽  
Quality Care ◽  
Structured Interviews ◽  
Rehabilitation Hospital ◽  
Person Centered Care ◽  
Centered Care ◽  
Multi Disciplinary Team

Background: Person-Centered Care (PCC) is a promising approach towards improved quality of care and cost containment within health systems. It has been evaluated in Sweden and England. This feasibility study examines initial PCC implementation in a rehabilitation hospital for children in Poland. Methods: The WE-CARE Roadmap of enablers was used to guide implementation of PCC for patients with moderate scoliosis. A multi-disciplinary team of professionals were trained in the PCC approach and the hospital Information Technology (IT) system was modified to enhance PCC data capture. Semi-structured interviews were conducted with the nine health care professionals involved in the pilot study and three patients/parents receiving care. Transcribed data were analyzed via content analysis. Results: 51 patients and their families were treated via a PCC approach. High proportions of new PCC data fields were completed by the professionals. The professionals were able to implement the three core PCC routines and perceived benefits using the PCC approach. Patients and their families also perceived improved quality care. The WE-CARE framework enablers facilitated PCC implementation in this setting. Conclusions: This feasibility pilot study indicates that the Gothenburg PCC approach can be successfully transferred to a rehabilitation hospital in Poland with favorable perceptions of implementation by both professionals and patients/their families.

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

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