Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design

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).

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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

10.21203/rs.2.12207/v1 ◽

2019 ◽

Author(s):

Marica Cassarino ◽

Katie Robinson ◽

Íde O’Shaughnessy ◽

Eimear Smalle ◽

Stephan White ◽

...

Keyword(s):

Older Adults ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Model Of Care ◽

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 outcomes include ED length of stay (from arrival to discharge) and incidence of inpatient admissions from the ED. Secondary outcomes include: ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days 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.

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Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04492-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Annabel Sandra Mueller-Stierlin ◽

Friedrich Meixner ◽

Anne Kohlmann ◽

Mara Schumacher ◽

Anke Hänsel ◽

...

Keyword(s):

Mental Health ◽

Health Care ◽

Mental Illness ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Mental Health Care ◽

Controlled Trial ◽

Community Based ◽

Care Programme ◽

Randomised Controlled

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A stepped-wedge randomised-controlled trial assessing the implementation, impact and costs of a prospective feedback loop to promote appropriate care and treatment for older patients in acute hospitals at the end of life: study protocol

BMC Geriatrics ◽

10.1186/s12877-020-01660-2 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Xing J. Lee ◽

Alison Farrington ◽

Hannah Carter ◽

Carla Shield ◽

Nicholas Graves ◽

...

Keyword(s):

Randomised Controlled Trial ◽

End Of Life ◽

Older Patients ◽

Feedback Loop ◽

Controlled Trial ◽

Stepped Wedge ◽

Life Study ◽

Appropriate Care ◽

Acute Hospitals ◽

Randomised Controlled

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Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community

BMJ Open ◽

10.1136/bmjopen-2019-030285 ◽

2019 ◽

Vol 9 (8) ◽

pp. e030285 ◽

Cited By ~ 2

Author(s):

Ricky Mullis ◽

Maria Raisa Jessica (Ryc) Aquino ◽

Sarah Natalie Dawson ◽

Vicki Johnson ◽

Sue Jowett ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Management ◽

Stroke Survivors ◽

Model Of Care ◽

New Model ◽

General Practices ◽

Randomised Controlled

IntroductionSurvival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care.Methods and analysisImproving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan.Trial registration numberNCT03353519

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Sustainable waiting time reductions after introducing the STAT model for access and triage: 12-month follow up of a stepped wedge cluster randomised controlled trial

BMC Health Services Research ◽

10.1186/s12913-020-05824-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Katherine E. Harding ◽

David A. Snowdon ◽

Luke Prendergast ◽

Annie K. Lewis ◽

Bridie Kent ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Waiting Time ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Trial Registration ◽

Stepped Wedge ◽

Community Based ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background Timely access is a challenge for providers of outpatient and community-based health services, as seen by the often lengthy waiting lists to manage demand. The Specific Timely Appointments for Triage (STAT) model, an alternative approach for managing access and triage, reduced waiting time by 34% in a stepped wedge cluster randomised controlled trial involving 8 services and more than 3000 participants. Follow up periods ranged from 3 to 10 months across the participating services in accordance with the stepped wedge design. This study aimed to determine whether outcomes were sustained for a full 12 months after implementation of the STAT model at each site. Methods Routinely collected service data were obtained for a total of 12 months following implementation of the STAT model at each of the 8 services that participated in a stepped wedge cluster randomised controlled trial. The primary outcome was time to first appointment. Secondary outcomes included non-attendance rates, time to second appointment and service use over 12 weeks. Outcomes were compared to pre-intervention data from the original trial, modelled using generalised linear mixed effects models accounting for clustering of sites. Results A 29% reduction in waiting time could be attributed to STAT over 12 months, compared to 34% in the original trial. A reduction in variability in waiting time was sustained. There were no significant changes in time to second appointment or in the number of missed appointments in the extended follow up period. Conclusions STAT is an effective strategy for reducing waiting time in community-based outpatient services. At 12 months, small reductions in the overall effect are apparent, but reductions in variability are sustained, suggesting that people who previously waited the longest benefit most from the STAT model. Trial registration This is a 12-month follow up of a stepped wedge cluster randomised controlled trial that was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12615001016527).

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