Cessation Service Use and Effectiveness for Hospitalized Smokers

Smoking Clinical Trial

— I-TSAR  

Official title:

Inpatient Technology-Supported Assisted Referral

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236079
• Other study ID #: 1U01HL105231-01
• Secondary ID: 1U01HL105231-01
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: August 29, 2016
• Start date: December 2011
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: July 2016
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Assisted referral & IVR
includes assistance in enrolling in outpatient cessation services, pharmacy orders for cessation medication, interactive voice recognition follow-up

Locations

Country	Name	City	State
United States	Kaiser Permanente Sunnyside	Clackamas	Oregon
United States	Legacy Emanuel Hospital	Portland	Oregon
United States	Oregon Health & Science Univeristy	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Legacy Health System, National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence		6 months	No