Clinical trial NCT01236079: Cessation Service Use and Effectiveness for Hospitalized Smokers
Official title: Inpatient Technology-Supported Assisted Referral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Legacy Health System
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-11-07
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Smoking abstinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clackamas
country: United States
facility: Kaiser Permanente Sunnyside
state: Oregon
city: Portland
country: United States
facility: Legacy Emanuel Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science Univeristy
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Jeffrey L Fellows, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.