Post-Discharge Smoking Cessation Strategies: Helping HAND 4 (HH4)

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Behavioral: eReferral to State Tobacco Quitline (QL); Drug: Nicotine replacement therapy; Behavioral: Transitional Tobacco Care Management (TTCM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03603496

2017P000774/PHS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,416 participants in 2 patient groups

Transitional Tobacco Care Management (TTCM)

Experimental group

Description:

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.

Treatment:

Behavioral: Transitional Tobacco Care Management (TTCM)

Drug: Nicotine replacement therapy

eReferral to State Tobacco Quitline (QL)

Active Comparator group

Description:

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.

Treatment:

Behavioral: eReferral to State Tobacco Quitline (QL)

Drug: Nicotine replacement therapy