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Cessation Service Use and Effectiveness for Hospitalized Smokers (I-TSAR)

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ClinicalTrials.gov Identifier: NCT01236079
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : August 31, 2016
Sponsor:
Collaborators:
Oregon Health and Science University
Legacy Health System
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The goal of this patient-randomized effectiveness trial is to demonstrate that an inpatient technology-supported assisted referral (I-TSAR) and follow-up approach is an effective and cost-effective method to help hospitalized patients successfully quit smoking. The proposed study represents a unique opportunity to assess the effectiveness and cost-effectiveness of linking inpatient and outpatient delivery of smoking cessation services in two large and very different health care delivery systems. We will enroll 900 participants (600 intervention, 300 controls) over 15-months and collect follow-up survey and health care utilization data over 12 months to estimate: 1) smoking abstinence at 6 and 12 months for I-TSAR intervention recipients compared to usual care; 2) the dose effect on smoking abstinence at 6 and 12 months for I-TSAR recipients compared to usual care; 3) total and mean costs per participant for I-TSAR and usual care recipients, and, if effective, estimate the incremental cost-effectiveness of the intervention vs. controls at 12 months from health plan/insurer and societal perspectives; and 4) differences in health care utilization at 12 months for I-TSAR versus controls.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Assisted referral & IVR Not Applicable

Detailed Description:

The goal of this patient-randomized effectiveness trial is to demonstrate that an inpatient technology-supported assisted referral (I-TSAR) and follow-up approach is an effective and cost-effective method to help hospitalized patients successfully quit smoking. The proposed study represents a unique opportunity to assess the effectiveness and cost-effectiveness of linking inpatient and outpatient delivery of smoking cessation services in two large and very different health care delivery systems. We will enroll 900 participants (600 intervention, 300 controls) over 15-months and collect follow-up survey and health care utilization data over 12 months to estimate: 1) smoking abstinence at 6 and 12 months for I-TSAR intervention recipients compared to usual care; 2) the dose effect on smoking abstinence at 6 and 12 months for I-TSAR recipients compared to usual care; 3) total and mean costs per participant for I-TSAR and usual care recipients, and, if effective, estimate the incremental cost-effectiveness of the intervention vs. controls at 12 months from health plan/insurer and societal perspectives; and 4) differences in health care utilization at 12 months for I-TSAR versus controls.

This innovative study will provide important evidence for the effectiveness and cost effectiveness of technologically supporting hospital-based tobacco treatment specialists' efforts to provide treatment assistance to smokers interested in quitting and arrange for telephone follow-up support. The Tobacco Treatment Specialists will identify and enroll into the study smokers and recent quitters (ages 18 and over) admitted to KSMC and OHSU inpatient units, and randomize participants into usual care and I-TSAR intervention arms. Patients enrolled into the treatment arm will receive information about existing tobacco cessation programs and medications, will be enrolled into the cessation program and medication of their choice while admitted, and will be enrolled to receive four post-discharge follow-up calls over 7 weeks using an automated interactive voice recognition program developed with and provided by Eliza Corp. The Tobacco Treatment Specialist will work with hospital staff to initiate pharmacy orders for cessation medications, and coordinate cessation treatment with the participants' usual source of primary care (provider or clinic). Study staff will also work with hospital staff and managers to develop periodic clinic enrollment feedback reports.

Testing the approach in two different health care systems will provide generalized data for other health plans and insurers about the value of using electronic medical records systems to help inpatient staff facilitate smoking cessation treatment after discharge.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Inpatient Technology-Supported Assisted Referral
Study Start Date : December 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Assisted Referral & IVR Behavioral: Assisted referral & IVR
includes assistance in enrolling in outpatient cessation services, pharmacy orders for cessation medication, interactive voice recognition follow-up
Other Name: pharmacologic treatment, interactive voice recognition follow-up calls
No Intervention: Usual Care



Primary Outcome Measures :
  1. Smoking abstinence [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • willing to remain abstinent post discharge
  • 1 cpd past 30 days
  • active phone
  • has a usual source of care
  • willing to participate
  • willing to provide contact information for follow up
  • provide informed consent

Exclusion Criteria:

  • critical care or labor/delivery units
  • pregnant or breastfeeding
  • physically unable to participate
  • cognitively impaired
  • no phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236079


Locations
United States, Oregon
Kaiser Permanente Sunnyside
Clackamas, Oregon, United States, 97015
Legacy Emanuel Hospital
Portland, Oregon, United States, 97227
Oregon Health & Science Univeristy
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Kaiser Permanente
Oregon Health and Science University
Legacy Health System
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeffrey L Fellows, PhD Kaiser Permanente