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

Assessing a WeChat-based integrative family intervention (WIFI) for schizophrenia: protocol for a type 2 hybrid effectiveness-implementation stepped-wedge cluster randomized trial

2020 ◽  
Author(s):  
YU YU ◽  
Tong-xin Li ◽  
Shi-jun Xi ◽  
Yi-lu Li ◽  
Qi-rui Li ◽  
...  
Keyword(s):  
Mental Illness ◽  
Family Caregivers ◽  
Family Caregiving ◽  
Cost Effective ◽  
Cluster Randomized Trial ◽  
Family Intervention ◽  
Cluster Randomized ◽  
Support Family

Abstract Background Schizophrenia is a persistent and debilitating mental illness, whose prognosis depends largely on supportive care and systematic treatment. In 2016, the Chinese government instituted a Reward Policy to financially support family caregiving of serious mental illness, including schizophrenia. However, family caregivers are still faced with many other challenges, such as lack of knowledge about serious mental illness, skills specific to family caregiving, social support, and other resources to assist with caring for a family member with schizophrenia. How to support family caregiving in an accessible, affordable, feasible and cost-effective way remains unresolved. The wide spread use of WeChat provides a promising and cost-effective medium for health intervention delivery. The current study aims to assess a WeChat WeChat-based integrative family intervention (WIFI) embedded in the Reward Policy to support family caregiving of schizophrenia. Methods We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of and the implementation process of the WIFI program. The program will include three core components: 1) psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through 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 the 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 two months during an 8-month intervention period in four clusters of 3 communities each. All clusters will receive the usual financial benefit of the Reward Policy as the control condition, and then successively and in random order, will cross over to the WIFI intervention at 2-month intervals until the study ends. Outcomes will be assessed for both family caregivers and the family member with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support and coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. Schizophrenia individuals will be assessed for their symptoms and functioning, quality of life, recovery and rehospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, we will collect process data including fidelity and quality of program implementation as well as users’ attitudes will also be collected. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling (GLMM) 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 (ICERs). Qualitative analysis will use the grounded theory approach and immersion-crystallization process. All statistical analyses will be conducted according to the intention-to-treat principle. Discussion This is the first hybrid effectiveness-implementation study to test a WeChat-based mHealth intervention to support family caregiving of 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 schizophrenia individuals. If found to be effective, the intervention could potentially be integrated into current national policy to support family caregiving. The intervention could also be adapted for use with other populations with a persistent and disabling condition.

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 Evaluating the instructional design and the effect on knowledge, teamwork, and skills of a technology-enhanced simulation-based training in obstetrics in Uganda: a stepped-wedge cluster randomized trial (Preprint)

2019 ◽  
Author(s):  
Anne Antonia Cornelia van Tetering ◽  
Maartje Henrica Martine Segers ◽  
Peter Ntuyo ◽  
Imelda Namagambe ◽  
M Beatrijs van der Hout-van der Jagt ◽  
...  
Keyword(s):  
Instructional Design ◽  
Low Income ◽  
Cluster Randomized Trial ◽  
Technical Skills ◽  
Stepped Wedge ◽  
Design Features ◽  
Low Income Country ◽  
Simulation Based ◽  
Cluster Randomized

BACKGROUND Simulation-based training is a common strategy for improving the quality of facility-based maternity services and is often evaluated using Kirkpatrick’s theoretical model. The results on the Kirkpatrick’s levels are closely related to the quality of the instructional design of a training program. The instructional design is generally considered as the ‘set of prescriptions for teaching methods to improve the quality of instruction with a goal of optimizing learning outcomes’. OBJECTIVE The aim of this study is to evaluate the instructional design of a technology-enhanced simulation-based training in obstetrics, the reaction of participants, and the effect on knowledge, teamwork, and skills in a low-income country. METHODS A stepped-wedge cluster randomized trial was performed in a University Hospital in Kampala, Uganda, with an annual delivery rate of over 31,000. In November 2014 a medical simulation center was installed with a full body birthing simulator (Noelle® S550, Gaumard, Miami), an interactive neonate (new-born Simon® S102, Gaumard, Miami) and an audio- and video recording system. Twelve local obstetricians were trained and certified as medical simulation trainer. From 2014 to 2016 training was provided to 57 residents in groups of six to nine students. Descriptive statistics were calculated for ten instructional design features of the training course measured by the 42-item ID-SIM. Wilcoxon signed rank test was conducted to investigate the difference in scores on knowledge, the clinical teamwork scale, and medical technical skills. RESULTS The mean scores on the ten instructional design features differed between 54.9 (95%CI 48.5 – 61.3) and 84.3 (95%CI 80.9-87.6) out of 100. The highest mean score was given on the feature feedback and the lowest scores on repetitive practice and controlled environment. The overall score for the training day was rated 92.8 out of 100 (95%CI 89.5 – 96.1). Knowledge improved significantly with a test score of 63.4 (95%CI 60.7 – 66.1) percent before and 78.9 (95%CI 76.8 – 81.1) percent after the training (P<.001). The overall score of the clinical teamwork scale, scored on a 10-point scale, was 6.0 (95%CI 4.4 – 7.6) before, and 5.9 (95%CI 4.5 – 7.2) after the training (P=.78). Medical technical skills were scored 55.5% (95%CI 47.2 – 63.8) before and 65.6% (95%CI 56.5 – 74.7) after training (P=.08). CONCLUSIONS Most instructional design features of a technology-enhanced simulation-based training in obstetrics in a low-income country were scored high, although intervals were large. The overall score for the training day was high, knowledge did improve after the training program, but no changes in teamwork and (most) medical technical skills were found. The lowest scored instructional design features may be improved to achieve further learning aims. CLINICALTRIAL ISRCTN98617255, retrospectively registered

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

scholarly journals Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Toles ◽  
C. Colón-Emeric ◽  
L. C. Hanson ◽  
M. Naylor ◽  
M. Weinberger ◽  
...  
Keyword(s):  
Acute Care ◽  
Transitional Care ◽  
Discharge Planning ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Skilled Nursing ◽  
Transition Plan ◽  
Cluster Randomized ◽  
Seriously Ill

Abstract Background Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90 days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home. Methods The study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients’ home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients (N = 360) and their caregivers (N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient’s illness at home; and (b) a Connect-Home Activation RN visits the patient’s home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient’s preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients’ quality of life, functional status, and days of acute care use and (b) caregivers’ burden and distress. Discussion Study results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications. Trial registration ClinicalTrials.gov NCT03810534. Registered on January 18, 2019.

scholarly journals Performance feedback on the quality of care in hospitals performing thrombectomy for ischemic stroke (PERFEQTOS): protocol of a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marzyeh Amini ◽  
Sanne J. den Hartog ◽  
Nikki van Leeuwen ◽  
Frank Eijkenaar ◽  
Laurien S. Kuhrij ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Quality Of Care ◽  
Performance Feedback ◽  
Primary Outcome ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Feedback Intervention ◽  
Endovascular Thrombectomy ◽  
Cluster Randomized

Abstract Background Although the provision of performance feedback to healthcare professionals based on data from quality registries is common practice in many fields of medicine, observational studies of its effect on the quality of care have shown mixed results. The objective of this study is to evaluate the effect of performance feedback on the quality of care for acute ischemic stroke. Methods PERFEQTOS is a stepped wedge cluster randomized trial in 13 hospitals in the Netherlands providing endovascular thrombectomy for ischemic stroke. The primary outcome is the hospital’s door-to-groin time. The study starts with a 6-month period in which none of the hospitals receives the performance feedback intervention. Subsequently, every 6 months, three or four hospitals are randomized to cross over from the control to the intervention conditions, until all hospitals receive the feedback intervention. The feedback intervention consists of a dashboard with quarterly reports on patient characteristics, structure, process, and outcome indicators related to patients with ischemic stroke treated with endovascular thrombectomy. Hospitals can compare their present performance with their own performance in the past and with other hospitals. The performance feedback is provided to local quality improvement teams in each hospital, who define their own targets on specific indicators and develop performance improvement plans. The impact of the performance feedback and improvement plans will be evaluated by comparing the primary outcome before and after the intervention. Discussion This study will provide evidence on the effectiveness of performance feedback to healthcare providers. The results will be actively disseminated through peer-reviewed journals, conference presentations, and various stakeholder engagement activities. Trial registration Netherlands Trial Register NL9090. Registered on December 3, 2020

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