The BEACON Study: An update to the protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario
Notice bibliographique
Résumé
Abstract BackgroundMen who present to the emergency department (ED) with self-harm are at high risk of dying by suicide, with 2.7% of men dying in the year following their presentation, more than double the rate for women (1.2%). Despite this, care received after an ED visit is highly variable and many are not assessed for psychological needs. Furthermore, the limited psychological care that is available is often not covered by provincial health insurance. Even when referrals for follow-up care are made, engagement rates are low. Previous recommendations to improve engagement include written discharge plans, caring contacts, and focused interventions targeting middle-aged men at elevated risk of dying by suicide. Blended care, the incorporation of technology into traditional care, has also been proposed as a method to increase engagement in and clinical benefits from psychotherapy. This project aims to determine whether the delivery of an evidence based treatment (Problem Solving Therapy - PST) iss enhanced by the addition of a custom smartphone application (BEACON) compared to usual care. Due to the impact of the COVID-19 pandemic on site participation and the planned implementation, we have made several changes to the study design, primary outcome and implementation.MethodWe originally proposed a cohort study nested within a larger cluster randomized trial wherein intervention sites would deliver the blended care, and control sites, whose personnel were not aware of their participation, would continue delivering usual care. The cohort study evaluated participant level outcomes as previously described by Hatcher et al (2020). Due to pandemic related constraints, our number of participating sites dropped to five potential sites which left the cohort study underpowered. As such, we changed the study design to a multi-site, individual randomized controlled trial (RCT) among the five remaining sites. Participants will be randomized to six sessions of therapy (PST) alone, or to the therapy plus BEACON, and followed up for 6 months. Our primary outcome was changed to evaluate feasibility and acceptability with the aim of designing a definitive RCT. Study implementation was reimagined to allow for completely virtual/online conduct to comply with local COVID-19 and institutional restrictions on in-person activities.ConclusionThis updated protocol will provide strong results for the planning of a definitive RCT of the blended care intervention in the future, addressing areas of difficulty and concern prior to its implementation. We will evaluate the feasibility of the study intervention, assess recruitment and retention of participants, and address challenges with implementing the protocol. Lastly, we will evaluate the appropriateness of our primary outcome measure and accurately determine a sample size for a definitive RCT.Trial Registration ClinicalTrials.gov, NCT03473535. Registered on March 22, 2018, https://clinicaltrials.gov/ct2/show/NCT03473535.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,067 | 0,051 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,004 |
| Méta-épidémiologie (sens large) | 0,006 | 0,006 |
| Bibliométrie | 0,003 | 0,004 |
| Études des sciences et des technologies | 0,005 | 0,002 |
| Communication savante | 0,003 | 0,003 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,004 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,029 | 0,007 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».