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 Screening by Social Workers in Medical Patients with Risk of Post-Acute Care Needs: A Stepped Wedge Cluster Randomized Trial / Evaluation eines Screenings durch Sozialarbeiter bei medizinischen Patienten mit einem Risiko für post-akuten Nachsorgebedarf: eine stepped wedge clusterrandomisierte Studie

2018 ◽  
Vol 5 (1) ◽  
pp. 25-34
Author(s):  
Antoinette Conca ◽  
Doaa Ebrahim ◽  
Sandra Noack ◽  
Angela Gabele ◽  
Helen Weber ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Social Workers ◽  
Acute Care ◽  
Discharge Planning ◽  
Control Period ◽  
Stepped Wedge ◽  
Intervention Period ◽  
Care Needs ◽  
Cluster Randomized ◽  
Post Acute Care

AbstractBackgroundElderly patients often need post-acute care after hospital discharge. Involvement of social workers can positively affect the discharge planning process.AimTo investigate the effect of screening patients at risk for post-acute care needs by social workers on time with respect to social workers’ notification, length of stay and delays in discharge compared to usual care.MethodsCluster randomized stepped wedge trial design for five clusters (wards) and two steps (control to intervention) was used. A total of 400 patients (200 per period) with high risk of post-acute care needs (defined as Post-Acute Care Discharge score, PACD ≥ 7) were included. Social workers performed a screening to decide about self-referral to their services (intervention period), which was compared to a highly structured standard SW notification by physicians and nurses (control period). A Generalized Estimating Equations model adjusted the clustering and baseline differences.ResultsA total of 139 patients were referred to social services (intervention: n = 76; control: n = 63). Time to social workers’ notification was significantly shorter in the intervention period when adjusted for all the differences in baseline (Mdn 1.2 vs 1.7, Beta = -0.73, 95%-CI 1.39 to -0.09). Both the length of stay and the delayed discharge time in nights showed no significant differences (Mdn 10.0 vs 9.1, Beta = -0.12, 95%-CI 0.46 to .22 nights 95%-CI, resp. Mdn 0.0 vs 0.0, Beta = .11, 95%-CI -0.64 to 0.86).ConclusionScreening speeded up social workers’ notification but did not accelerate the discharge processes. The screening by social workers might show process improvement in settings with less structured discharge planning.

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 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 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 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

Digital Adherence Technology for Tuberculosis Treatment Supervision: A Stepped-Wedge Cluster Randomized Trial

2020 ◽  
Author(s):  
Adithya Cattamanchi ◽  
Rebecca R. Crowder ◽  
Alex Kityamuwesi ◽  
Noah Kiwanuka ◽  
Maureen Lamunu ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Tuberculosis Treatment ◽  
Stepped Wedge ◽  
Cluster Randomized

scholarly journals Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marc-Eric Nadeau ◽  
Justine L. Henry ◽  
Todd C. Lee ◽  
Émilie Bortolussi-Courval ◽  
Carole Goodine ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Trial ◽  
Study Design ◽  
Long Term Care ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Term Care ◽  
Medication Reviews ◽  
Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

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