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

Inpatient Technology-Supported Assisted Referral

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Assisted referral & IVR

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
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Kaiser Permanente Sunnyside
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
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 Names: pharmacologic treatment, interactive voice recognition follow-up calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking abstinence	6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Oregon Health and Science University; Legacy Health System
• Investigators: Principal Investigator: Jeffrey L Fellows, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Fellows JL, Mularski RA, Leo MC, Bentz CJ, Waiwaiole LA, Francisco MC, Funkhouser K, Stoney CM. Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial. Am J Prev Med. 2016 Oct;51(4):609-19. doi: 10.1016/j.amepre.2016.06.014.
• Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
• Fellows JL, Mularski R, Waiwaiole L, Funkhouser K, Mitchell J, Arnold K, Luke S. Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:129. doi: 10.1186/1745-6215-13-129.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1U01HL105231-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No