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Smoking Interventions for Hospital Patients (Helping HAND)

16 de septiembre de 2014 actualizado por: Nancy A. Rigotti, Massachusetts General Hospital

Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial

Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related disease or death. A hospital admission provides an opportunity for a smoker to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for >1 month after discharge. Smoking cessation medications add benefit to counseling but are not often used. The challenge is to translate this efficacy research into routine clinical practice. The major barrier is to make the transition from inpatient to outpatient care. An evidence-based, cost-effective intervention model that can be adopted by U.S. hospitals is needed to realize the potential impact of hospital smoking interventions.

The Specific Aim of this project is to conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in hospitalized patients: (1) a hospital-only intervention that meets the current standard of the National Hospital Quality Measures("Standard Care"), and (2) an "Extended Care Management" model with 2 components that aims to encourage and facilitate the sustained use of smoking cessation treatment (counseling and medication use) after discharge in order to achieve long-term abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and feature 2 innovations: (1) to increase medication use, smokers willing to make a quit attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers interested in or most likely to benefit from continued counseling after discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care, is feasible and will increase (1) the use of smoking cessation treatment after discharge, (2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence 6 months after hospital discharge (primary outcome). The principal secondary outcome measure is self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months, prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The cost-effectiveness (cost per quit) of the interventions will be also be compared.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

397

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Cigarette smoker (daily smoker when smoking in usual way during the month before hospital admission)
  • Counseled by hospital smoking counselor during hospital stay
  • Plans to stop smoking tobacco products after hospital discharge
  • Appropriate for use of smoking cessation medication after discharge

Exclusion Criteria:

  • Expected hospital length of stay <24 hours
  • Not expected to be discharged to home
  • No access to a telephone
  • Unable to communicate by telephone
  • Severe psychiatric or neurologic disease precluding ability to be counseled
  • Pregnant, nursing, or planning to become pregnant in next 3 months
  • Active substance abuse other than tobacco
  • Unable to speak English

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Standard Care
Standard tobacco counseling provided to hospital inpatients as part of routine, clinical-guideline compliant care in the study hospital. No post-discharge treatment is offered in this arm.
Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
Experimental: Extended Care Management
In addition to Standard Care, subjects in this arm receive Extended Care Management intervention to facilitate the continued use of smoking cessation treatment (counseling and medication use) after hospital discharge. This consists of 3 months of telephone-based contact after discharge.
Telephone-based care management of tobacco cessation for 3 months after hospital discharge that features 2 innovations: (1) to increase medication use, smokers receive a free refillable 30-day sample of their choice of FDA-approved smoking cessation medication (nicotine replacement, bupropion, or varenicline) at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers seeking or most likely to benefit from continued counseling after hospital discharge.
Otros nombres:
  • vareniclina
  • bupropión
  • terapia de reemplazo de nicotina
  • interactive voice response
  • telephone counseling for smoking cessation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Validated 7-day point prevalence tobacco abstinence
Periodo de tiempo: 6 months after discharge
7-day point prevalence tobacco abstinence, validated by saliva cotinine <= 10 ng/ml or if using NRT, expired air CO <=9ppm, or confirmation by proxy
6 months after discharge

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Use of tobacco treatment after hospital discharge
Periodo de tiempo: during 3 months and 6 months after hospital discharge
patient-reported receipt of either smoking cessation counseling (defined as contact in person or by telephone) or smoking cessation pharmacotherapy (use of nicotine replacement therapy, bupropion, or varenicline)in the 3 months after hospital discharge
during 3 months and 6 months after hospital discharge
Duration of tobacco abstinence after hospital discharge
Periodo de tiempo: Up to 6 months after hospital discharge
Number of days that patient reports not smoking any tobacco product after hospital discharge
Up to 6 months after hospital discharge
Self-reported 7-day point prevalence tobacco abstinence
Periodo de tiempo: 6 month follow-up
6 month follow-up
Self-reported 7-day point prevalence tobacco abstinence
Periodo de tiempo: 3 months after hospital dicharge
3 months after hospital dicharge
Self-reported 7-day point prevalence tobacco abstinence
Periodo de tiempo: 1 month after hospital discharge
1 month after hospital discharge
Prolonged tobacco abstinence
Periodo de tiempo: at 1, 3, and 6 months after hospital discharge
Self-reported 7-day point prevalence abstinence at each of 3 time points: 1 month, 3 months, and 6 months after hospital discharge
at 1, 3, and 6 months after hospital discharge
Continuous tobacco abstinence
Periodo de tiempo: Up to 6 months after hospital discharge
Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge
Up to 6 months after hospital discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2010

Finalización primaria (Actual)

1 de noviembre de 2012

Finalización del estudio (Actual)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2010

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2010

Publicado por primera vez (Estimar)

6 de agosto de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de septiembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2014

Última verificación

1 de septiembre de 2014

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Standard Care

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