Cessation Service Use and Effectiveness for Hospitalized Smokers

NCT ID: NCT01236079

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Assisted Referral & IVR

Group Type EXPERIMENTAL

Assisted referral & IVR

Intervention Type BEHAVIORAL

includes assistance in enrolling in outpatient cessation services, pharmacy orders for cessation medication, interactive voice recognition follow-up

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Assisted referral & IVR

includes assistance in enrolling in outpatient cessation services, pharmacy orders for cessation medication, interactive voice recognition follow-up

Intervention Type BEHAVIORAL

Other Intervention Names

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pharmacologic treatment, interactive voice recognition follow-up calls

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

Legacy Health System

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey L Fellows, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Sunnyside

Clackamas, Oregon, United States

Site Status

Legacy Emanuel Hospital

Portland, Oregon, United States

Site Status

Oregon Health & Science Univeristy

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27647061 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26336372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22853325 (View on PubMed)

Other Identifiers

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1U01HL105231-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1U01HL105231-01

Identifier Type: NIH

Identifier Source: org_study_id

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