Terminé

Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

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Ce qui est testé

AD + Integrated Tobacco Order Set

Autre
Qui peut participer

Troubles Mentaux+1

+ Troubles liés aux substances

+ Troubles Induits par Produits Chimiques

À partir de 18 ans
+19 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : août 2013
Voir le détail du protocole

Résumé

Sponsor principalYale University
Dernière mise à jour : 5 septembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 août 2013

Date à laquelle le premier participant a commencé l'étude.

Cigarette smoking remains the leading cause of preventable death and illness in the United States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have far-reaching implications for the individual, workplace, society and the healthcare system. However, treatment is associated with significant individual and society benefits, and both counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with poverty and low education, smoking causes a greater loss of quality-adjusted life years than race, uninsurance, overweight, or binge drinking. Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that US hospitals are now smoke-free (per Joint Commission regulations), and many of these admissions are for tobacco-related conditions, the hospital admission represents a profound opportunity-a "teachable moment"-for tobacco control. Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and Medicaid Services require hospitals to report publicly their tobacco screening for patients admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although many hospitals have improved their performance considerably on these smoking measures, sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted instruction sheet that includes boilerplate text about smoking cessation. Thus, although most hospitals assess inpatients for tobacco use (either through a nursing assessment or the physician's initial history and physical examination), there are often no systems in place to initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents millions of smokers from accessing the many effective, evidence-based treatments for tobacco dependence during a period in which they may be particularly receptive to an intervention. Hence, the overarching goal of this project is to implement and study the effectiveness and cost-effectiveness of a tobacco intervention for hospitalized adults that begins during inpatient treatment and continues after discharge. To enhance dissemination, we will use resources currently available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses, and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL). In the final year, a toolkit will be disseminated by professional societies. We hypothesize that the proposed intervention is clinically effective, cost effective, sustainable, and generalizable. All interventions are evidence-based and consistent with the 2008 Public Health Service clinical practice guideline for tobacco dependence treatment. The Specific Aims of the proposed project are to: Primary Aims: Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS) compared to AD alone improves biologically verified smoking cessation at 12 months post-quit in a cohort of 960 smokers age > 18 years admitted to Yale New Haven Hospital (YNHH). Secondary Aims: Study ITOS's ability to encourage smokers to use treatment services and reduce consumption. Study ITOS's ability to enhance provider delivery of tobacco screening and treatment. Conduct an incremental cost-effectiveness analysis of the intervention. Our associated hypotheses are: Subjects treated by physicians in the AD+ITOS arm will have a higher rate of biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted to the inpatient units of Yale-New Haven Hospital. Subjects treated by AD+ITOS physicians will have made more quit attempts, and experienced greater reduction in daily cigarette consumption, than smokers treated by AD physicians. A higher proportion of patients treated by AD+ITOS physicians will have tobacco treatment initiated in hospital than patients treated by AD physicians. Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.

NCT01691105
Sponsor principalYale University
Dernière mise à jour : 5 septembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

1044 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxTroubles liés aux substancesTroubles Induits par Produits ChimiquesTrouble de l'usage du tabac

Critères

5 critères d'inclusion nécessaires pour participer
18 years or older

able to give written informed consent

admitted to any medical ward, telemetry or cardiac care unit

identified as a smoker by the nurse or physician in the admitting EMR

Voir plus de critères

14 critères d'exclusion empêchent la participation
current psychotic disorder or life-threatening or unstable medical or psychiatric condition within past 6 months

current suicide or homicide risk

currently receiving formal tobacco dependence treatment

do not have access to a phone with a CT area code (required to use the CT Tobacco Quitline)

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Pas d'intervention
Standard of care for patients who are smokers and admitted to the hospital.

Groupe II

Expérimental
Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Yale University

New Haven, United StatesOuvrir Yale University dans Google Maps
Terminé1 Centres d'Étude