NCT01236079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

October 7, 2010

Last Update Submit

August 29, 2016

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence

    6 months

Study Arms (2)

Assisted Referral & IVR

EXPERIMENTAL
Behavioral: Assisted referral & IVR

Usual Care

NO INTERVENTION

Interventions

Assisted referral & IVRBEHAVIORAL

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

Also known as: pharmacologic treatment, interactive voice recognition follow-up calls
Assisted Referral & IVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willing to remain abstinent post discharge
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente Sunnyside

Clackamas, Oregon, 97015, United States

Location

Legacy Emanuel Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health & Science Univeristy

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • 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.

    PMID: 27647061DERIVED

  • 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.

    PMID: 26336372DERIVED

  • 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.

    PMID: 22853325DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jeffrey L Fellows, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2010

First Posted

November 8, 2010

Study Start

December 1, 2011

Primary Completion

November 1, 2013

Study Completion

July 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

US(3)