Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-11-17

Brief Summary

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This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.

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Detailed Description

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This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transitional Tobacco Care Management (TTCM)

TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.

Group Type EXPERIMENTAL

Transitional Tobacco Care Management (TTCM)

Intervention Type BEHAVIORAL

PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.

Nicotine replacement therapy

Intervention Type DRUG

Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.

eReferral to State Tobacco Quitline (QL)

Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.

Group Type ACTIVE_COMPARATOR

eReferral to State Tobacco Quitline (QL)

Intervention Type BEHAVIORAL

Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.

Nicotine replacement therapy

Intervention Type DRUG

Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.

Interventions

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Transitional Tobacco Care Management (TTCM)

PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.

Intervention Type BEHAVIORAL

eReferral to State Tobacco Quitline (QL)

Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.

Intervention Type BEHAVIORAL

Nicotine replacement therapy

Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Current cigarette smoker (\>=1 cigarette in the week before admission and \>=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
* Admitted to a study hospital
* Seen by hospital smoking counselor during inpatient stay
* Plans to try to quit smoking after hospital discharge

Exclusion Criteria

* Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
* Life expectancy \<12 months
* Medical instability
* No reliable telephone access or inability to use telephone
* Non-English speaking
* Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No