A 6‐month prospective randomized controlled trial of remotely delivered group format epilepsy self‐management versus waitlist control for high‐risk people with epilepsy

Sajatovic, Martha; Colón-Zimmermann, Kari; Kahriman, Mustafa; Fuentes-Casiano, Edna; Liu, Hongyan; Tatsuoka, Curtis; Cassidy, Kristin A.; Lhatoo, Samden D.; Einstadter, Douglas; Chen, Peijun

doi:10.1111/epi.14527

Cited by 57 publications

(34 citation statements)

References 37 publications

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“…Targeted Training for Illness Management (TTIM) is an evidence-based, manualized, modular group intervention for the self-management of chronic illness, originally developed for people with severe mental illness. The evidence-based TTIM approach has been successfully adapted for a variety of chronic health conditions including epilepsy, stroke, Parkinson's disease, and diabetes [32][33][34][35][36]. TTIM was selected for this study by our stakeholders because it met the criteria for having both physical and mental health topics and had a version specific to diabetes.…”

Section: Curriculummentioning

confidence: 99%

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Kwan

Dickinson

Glasgow

et al. 2020

Trials

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Background: Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. Methods: This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice-and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practicelevel value and sustainability. Discussion: Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model.

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Section: Curriculummentioning

confidence: 99%

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Kwan

Dickinson

Glasgow

et al. 2020

Trials

Self Cite

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“…One in the USA looked at the delivery of self-management intervention for people with epilepsy and a history of negative health events (SMART) using wide ranging assessment tools. It found that participants who had better SMART attendance had a reduction in negative health events counts (NHE), and seizure frequency, from base line to six month when compared to controls, however, seizure severity was not reduced, and no significance was found when specifically looking at ED attendance [22]. A US quality improvement project looked at the use of educational materials focusing on self-management and seizure first aid, such as educational handouts and a DVD, to see whether they reduced ED attendances.…”

Section: Educational Interventionsmentioning

confidence: 99%

“…Six reports looked at educational programmes for people living with epilepsy attending EDs [22][23][24][25][26][27]. One in the USA looked at the delivery of self-management intervention for people with epilepsy and a history of negative health events (SMART) using wide ranging assessment tools.…”

Section: Educational Interventionsmentioning

confidence: 99%

Exploring epilepsy attendance at the emergency department and interventions which may reduce unnecessary attendances: A scoping review

Burrows

Lennard

Hudson

et al. 2020

Seizure

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Background: Repeat attendances to emergency departments for seizures, impacts on the individual and burdens health care systems. We conducted a review to identify implementable measures which improve the management of people with epilepsy reducing healthcare costs and their supportive evidence. Methods: A scoping review design using suitable search strategy as outlined by PRISMA-ScR was used to examine seven databases: MEDLINE, EMBASE, CINAHL, AMED, PsychINFO, HMIC and BNI. A manual search of the COCHRANE database and citation searching was also conducted. A thematic analysis was conducted to explore the context and reasons of emergency department attendance for seizures, particularly repeat attendances and the strategies and measures deployed to reduce repeat attendances. Results: Twenty-nine reports were included, comprising of a systematic review, a randomised control study, a multi-method study, quantitative studies (n = 17), qualitative studies (n = 6), an audit, a survey and a quality improvement project. Thematic analysis identified four broad areas for reducing repeat attendances. These were developing care pathways, conducting care and treatment reviews, providing educational interventions and role of ambulance staff. Conclusion: The findings indicate varied reasons for attendance at ED following seizure, including mental health and knowledge of seizure management and lack of education. Implementations of care pathways in ED have been found to reduce admission related costs.

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“…Specifically, only one RCT-by Sajatovic et al 60 has considered change in ED use following epilepsy self-management. 61 Conducted in the USA, it compared 'Self-MAnagement for people with epilepsy and ahistoRy of negative health evenTs' (SMART)-an 8-session group intervention-to wait list control.…”

Section: Discussionmentioning

confidence: 99%

Seizure First Aid Training For people with Epilepsy (SAFE) frequently attending emergency departments and their significant others: results of a UK multi-centre randomised controlled pilot trial

et al. 2020

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ObjectiveTo determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).DesignPilot RCT with embedded microcosting.SettingThree English hospital emergency departments (EDs).ParticipantsPatients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs).InterventionsPatients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course.Main outcome measuresTwo criteria evaluated a definitive RCT’s feasibility: (1) ≥20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12 months postrandomisation needed securing for ≥75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE’s effect and intervention cost.ResultsOf ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12 months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ~674 patient participants and ~39 recruitment sites. Obtaining routine data was challenging, taking ~8.5 months.ConclusionsIn satisfying only one predetermined ‘stop/go’ criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial’s finding’s external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population.Trial registration numberISRCTN13871327

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A 6‐month prospective randomized controlled trial of remotely delivered group format epilepsy self‐management versus waitlist control for high‐risk people with epilepsy

Abstract: SMART is associated with reduced health complications and improved mood, quality of life, and health functioning in high-risk people with epilepsy. Additional efforts are needed to investigate potential for scale-up.

Cited by 57 publications

References 37 publications

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Exploring epilepsy attendance at the emergency department and interventions which may reduce unnecessary attendances: A scoping review

Seizure First Aid Training For people with Epilepsy (SAFE) frequently attending emergency departments and their significant others: results of a UK multi-centre randomised controlled pilot trial

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