A Web-Based Contraception Decision Tool for Individuals With Health Conditions in US Outpatient Clinics: Protocol for a Mixed Methods Cluster Randomized Controlled Trial
Notice bibliographique
Résumé
BACKGROUND: Choosing contraception is a highly personal, often complex decision. People with acute and chronic health conditions (eg, pulmonary embolism, diabetes, and hypertension) must deliberate additional factors including whether and to what extent a contraceptive method may affect their health conditions or interact with their medications. "My Health My Choice" (web application developed by Alfa Jango) is a web-based decision support tool designed to help patients understand their contraceptive options considering their health conditions, medications, and personal priorities. OBJECTIVE: We will evaluate the efficacy of "My Health My Choice" (MHMC) use among people with diverse health conditions who seek contraception in US outpatient clinics. METHODS: This mixed methods cluster randomized controlled trial will compare MHMC and usual contraceptive care (intervention arm) to usual contraceptive care only (control arm). Fourteen clinics that specialize in primary care or obstetrics and gynecology will be enrolled, with 7 clinics in each arm. We will enroll 726 patients (363 in each group) who (1) are 18-49 years old, (2) are able to speak and read English, (3) are seeking contraception for pregnancy prevention, and (4) have at least 1 health condition among 60 eligible health conditions and characteristics (eg, cigarette smoking and postpartum state). Aim 1 (quantitative) is to assess the primary outcome of patient-reported contraceptive nonuse (yes or no) at 3 months. Aim 2 (mixed methods) starts with a quantitative summary of patient-reported contraceptive use by method type (eg, pills and shot) and corresponding Medical Eligibility Risk Category (Category 1, 2, 3, or 4) based on the Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria (US MEC) Contraceptive Guidelines. We will conduct exit interviews of a subsample of approximately 30 patients and 30 clinicians to qualitatively understand how MHMC and other contextual factors influenced perceptions about contraceptive risk and contraceptive decisions. Aim 3 (quantitative) is to explore patient-reported contraceptive decisional conflict (measured by the Decisional Conflict Scale) and patient-reported quality of interaction with their contraceptive provider (measured by the Interpersonal Quality of Family Planning Scale) as mediators of the effects of MHMC on the primary outcome. This paper describes the study protocol per the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) checklist. RESULTS: The National Institute of Child Health and Human Development funded this study (R01HD110570, Principal Investigator JPW) in 2023. The study team is collaborating with the DARTNet Institute (Aurora, Colorado) to enroll and prepare health clinics for trial launch. Fourteen clinics have enrolled in the trial and are in various stages of study preparation and regulatory approval. We anticipate patient enrollment to run from October 2025 to September 2028. CONCLUSIONS: This is the first mixed methods cluster randomized controlled trial of MHMC, a novel web-based decision support tool for people with health conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT07075536; https://clinicaltrials.gov/study/NCT07075536. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71101.
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,043 | 0,017 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».