scholarly journals Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ryan K. McBain ◽  
Owen Mwale ◽  
Todd Ruderman ◽  
Waste Kayira ◽  
Emilia Connolly ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Treatment Adherence ◽  
Chronic Care ◽  
Cost Effective ◽  
Stepped Care ◽  
Depression Symptoms ◽  
Stepped Wedge ◽  
Depression Care ◽  
Link Type ◽  
Cluster Randomized

Abstract Background Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. Methods We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model’s cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. Discussion This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. Trial registration ClinicalTrials.govNCT04777006. Registered on 1 March, 2021

Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

2015 ◽  
Vol 63 (12) ◽  
pp. 2494-2504 ◽  
Author(s):  
Karen M. van Leeuwen ◽  
Judith E. Bosmans ◽  
Aaltje P. D. Jansen ◽  
Emiel O. Hoogendijk ◽  
Maaike E. Muntinga ◽  
...  
Keyword(s):  
Older Adults ◽  
Primary Care ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Chronic Care Model ◽  
Chronic Care ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Care Model ◽  
Cluster Randomized

scholarly journals Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial (Preprint)

2020 ◽  
Author(s):  
Yu Yu ◽  
Tongxin Li ◽  
Shijun Xi ◽  
Yilu Li ◽  
Xi Xiao ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Family Caregivers ◽  
Family Caregiving ◽  
Cost Effective ◽  
Cluster Randomized Trial ◽  
Family Intervention ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Support Family

BACKGROUND Schizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support. OBJECTIVE We aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia. METHODS We will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process. RESULTS The study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020. CONCLUSIONS This is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations. CLINICALTRIAL ClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18538

scholarly journals Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial

10.2196/18538 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18538 ◽  
Author(s):  
Yu Yu ◽  
Tongxin Li ◽  
Shijun Xi ◽  
Yilu Li ◽  
Xi Xiao ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Family Caregivers ◽  
Family Caregiving ◽  
Cost Effective ◽  
Cluster Randomized Trial ◽  
Family Intervention ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Support Family

Background Schizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support. Objective We aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia. Methods We will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process. Results The study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020. Conclusions This is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations. Trial Registration ClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896. International Registered Report Identifier (IRRID) PRR1-10.2196/18538

scholarly journals Cost-effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: economic evaluation alongside a stepped-wedge cluster-randomised trial

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e017782
Author(s):  
Esther V A Bouwsma ◽  
Judith E Bosmans ◽  
Johanna M van Dongen ◽  
Hans A M Brölmann ◽  
Johannes R Anema ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Perioperative Care ◽  
Cost Effective ◽  
Stepped Wedge ◽  
Gynaecological Surgery ◽  
Care Programme ◽  
Societal Costs ◽  
Cluster Randomised

ObjectivesTo evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients.DesignEconomic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up.SettingSecondary care, nine hospitals in the Netherlands, 2011–2014.Participants433 employed women aged 18–65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery.InterventionThe intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227).Main outcome measuresThe primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery.ResultsAt 12 months, there were no statistically significant differences in total societal costs (€−647; 95% CI €−2116 to €753) and duration until RTW (−4.1; 95% CI −10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs.ConclusionsConsidering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery.Trial registration numberNTR2933; Results.

scholarly journals The cost-effectiveness of pegaspargase versus native asparaginase for first-line treatment of acute lymphoblastic leukaemia: a UK-based cost-utility analysis

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Xingdi Hu ◽  
Kingsley P. Wildman ◽  
Subham Basu ◽  
Peggy L. Lin ◽  
Clare Rowntree ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
Link Type ◽  
Search Trial ◽  
Erwinia Asparaginase ◽  
The Uk ◽  
The Cost

Abstract Background L-asparaginase is a key component of treatment for patients with acute lymphoblastic leukaemia (ALL) in the UK. Commonly used forms of asparaginase are native E. coli-derived asparaginase (native asparaginase) and pegaspargase in first-line combination therapy, and native Erwinia chrysanthemi-derived asparaginase (Erwinia asparaginase) as second-line treatment. The objective of this study was to evaluate the cost-effectiveness of pegaspargase versus native asparaginase in first-line combination therapy for patients with newly diagnosed ALL. A combined decision tree and health-state transition Markov cost-effectiveness model was developed to assess the relative costs and health outcomes of pegaspargase versus native asparaginase in the UK setting. Results In base case analyses, first-line pegaspargase (followed by Erwinia asparaginase in cases of hypersensitivity) dominated first-line native asparaginase followed by Erwinia asparaginase; i.e. resulted in lower costs and more quality-adjusted life year gain. The favourable hypersensitivity rates and administration profile of pegaspargase led to lifetime cost savings of £4741 versus native asparaginase. Pegaspargase remained cost-effective versus all treatment strategies in all scenario analyses, including use of the 2500 IU/m2 dose, recommended for patients ≤21 years of age. Conclusions Pegaspargase, as part of multi-drug chemotherapy, is a cost-effective option for the treatment of newly diagnosed ALL. Based on this study, The National Institute for Health and Care Excellence Technology Appraisal Committee concluded that it could recommend pegaspargase as a cost-effective use of National Health Service resources in England & Wales for treating ALL in children, young people and adults with untreated, newly diagnosed disease. Trial registration UKALL 2011, EudraCT number 2010-020924-22; UKALL 2003, EudraCT number 2007-004013-34; UKALL14, EudraCT number 2009-012717-22.

scholarly journals Exploring the cost-effectiveness of a Dutch collaborative stepped care intervention for the treatment of depression and/or anxiety when adapted to the Australian context: a model-based cost-utility analysis

2021 ◽  
Vol 30 ◽  
Author(s):  
Y. Y. Lee ◽  
M. G. Harris ◽  
H. A. Whiteford ◽  
S. K. Davidson ◽  
M. L. Chatterton ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Health Outcomes ◽  
Cost Effective ◽  
Stepped Care ◽  
Primary Care Settings ◽  
Self Help ◽  
Australian Context ◽  
Treatment Of Depression ◽  
The Cost

Abstract Aims Depression and anxiety are among the most common mental health conditions treated in primary care. They frequently co-occur and involve recommended treatments that overlap. Evidence from randomised controlled trials (RCTs) shows specific stepped care interventions to be cost-effective in improving symptom remission. However, most RCTs have focused on either depression or anxiety, which limits their generalisability to routine primary care settings. This study aimed to evaluate the cost-effectiveness of a collaborative stepped care (CSC) intervention to treat depression and/or anxiety among adults in Australian primary care settings. Method A quasi-decision tree model was developed to evaluate the cost-effectiveness of a CSC intervention relative to care-as-usual (CAU). The model adapted a CSC intervention described in a previous Dutch RCT to the Australian context. This 8-month, cluster RCT recruited patients with depression and/or anxiety (n = 158) from 30 primary care clinics in the Netherlands. The CSC intervention involved two steps: (1) guided self-help with a nurse at a primary care clinic; and (2) referral to specialised mental healthcare. The cost-effectiveness model adopted a health sector perspective and synthesised data from two main sources: RCT data on intervention pathways, remission probabilities and healthcare service utilisation; and Australia-specific data on demography, epidemiology and unit costs from external sources. Incremental costs and incremental health outcomes were estimated across a 1-year time horizon. Health outcomes were measured as disability-adjusted life years (DALYs) due to remitted cases of depression and/or anxiety. Incremental cost-effectiveness ratios (ICERs) were measured in 2019 Australian dollars (A$) per DALY averted. Uncertainty and sensitivity analyses were performed to test the robustness of cost-effectiveness findings. Result The CSC intervention had a high probability (99.6%) of being cost-effective relative to CAU. The resulting ICER (A$5207/DALY; 95% uncertainty interval: dominant to 25 345) fell below the willingness-to-pay threshold of A$50 000/DALY. ICERs were robust to changes in model parameters and assumptions. Conclusions This study found that a Dutch CSC intervention, with nurse-delivered guided self-help treatment as a first step, could potentially be cost-effective in treating depression and/or anxiety if transferred to the Australian primary care context. However, adaptations may be required to ensure feasibility and acceptability in the Australian healthcare context. In addition, further evidence is needed to verify the real-world cost-effectiveness of the CSC intervention when implemented in routine practice and to evaluate its effectiveness/cost-effectiveness when compared to other viable stepped care interventions for the treatment of depression and/or anxiety.

scholarly journals Cost-Effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression – a cluster-randomized trial

2020 ◽  
Author(s):  
Christian Brettschneider ◽  
Daniela Heddaeus ◽  
Maya Steinmann ◽  
Martin Härter ◽  
Birgit Watzke ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Controlled Trial ◽  
Treatment Guideline ◽  
Stepped Care ◽  
Control Group ◽  
Care Model ◽  
Treatment As Usual ◽  
Life Years ◽  
Cluster Randomized

Abstract Objective Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped-care model based on the German National Clinical Practice Guideline “Unipolar Depression” has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus standard care in depression. Methods This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D as effect measure. Resource utilization was assessed by patient questionnaires. We calculated adjusted group differences in costs and effects, incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. The complete sample and subgroups based on depression severity were considered. Results In the IG, adjusted mean total costs (+5,016; SE: €2,691) and effects (+0.008 QALY; SE: 0.02) were higher than in the CG; yet, differences were not statistically significant. Significantly increased costs were found in the IG for outpatient physician services and psychiatrist services. Significantly increased total and indirect costs in the IG were found in the group with severe depression. Incremental cost-effectiveness ratios were unfavourable and the probability of cost-effectiveness was low, except for the group with moderate depression (70% for willingness-to-pay threshold of €50,000/QALY). Conclusions We found no evidence for cost-effectiveness of the intervention. However, we identified indicators that the intervention works according to the aims of the National Treatment Guideline.

scholarly journals Depression in the nursing home: a cluster-randomized stepped-wedge study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)

2019 ◽  
Author(s):  
Valentina Antonia Tesky ◽  
Arthur Schall ◽  
Ulrike Schulze ◽  
Ulrich Stangier ◽  
Frank Oswald ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Nursing Home ◽  
Case Management ◽  
Nursing Home Residents ◽  
Depression Symptoms ◽  
Stepped Wedge ◽  
Diagnosis Of Dementia ◽  
Cluster Randomized

Abstract Background Depression is the second most common psychiatric illness in old people. Up to 30% of nursing home residents suffer from minor or major depression. Although depressive disorders in old age can be improved and even cured with adequate therapy, they often go unnoticed in nursing home residents and remain untreated. This highlights a striking deficit in health care and might results not only in lower quality of life among those concerned but also in poor physical functioning, premature mortality and increased hospitalization rates. Methods The aim of the interdisciplinary research project DAVOS is to implement an innovative and stepped structural case management program to improve depression treatment in nursing home residents by a modularized intervention and to assess it in terms of its effectiveness. Intervention modules are in line with recommendations given by the German national treatment guidelines for depression (S3 guidelines). Ten nursing homes in Frankfurt, Germany, will participate in the project which aims to recruit a study population of N = 380. The recruitment will continue throughout the trial (open cohort). Persons (>60 years) that live in a nursing home, have no medical diagnosis of dementia and can provide their informed consent to participate are eligible for inclusion in the study. Residents with a clinical diagnosis of dementia, alcohol or substance related disorders or other serious psychiatric illnesses will be excluded. DAVOS is a controlled cluster-randomized study that employs a stepped-wedge design. Discussion Our main hypothesis is that the implementation of the intervention will lead to a decline in the prevalence of depression and a reduction in depression symptoms among the home residents. In addition, we expect the intervention to have a positive impact on secondary outcomes such as level of functioning, quality of life and social participation. The project’s results can make an important contribution towards improving the health care of nursing home residents suffering from late-life depression.

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