Trial Outcomes & Findings for Post-Discharge Smoking Cessation Strategies: Helping HAND 4 (NCT NCT03603496)

NCT ID: NCT03603496

Last Updated: 2022-05-05

Results Overview

Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1416 participants
• Primary outcome timeframe: 6 months after hospital discharge
• Results posted on: 2022-05-05

Participant Flow

708 patients were randomized to TTCM arm. 2 patients were excluded post-randomization but before hospital discharge and the start of the intervention and follow-up assessment due to not meeting eligibility criteria. 708 patients were randomized to QL arm. 5 patients were excluded post-randomization but before hospital discharge and the start of the intervention and follow-up assessment due to not meeting eligibility criteria.

Participant milestones

Measure	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. Transitional Tobacco Care Management (TTCM): TTCM 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: 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Overall Study STARTED	706	703
Overall Study COMPLETED	520	518
Overall Study NOT COMPLETED	186	185

Reasons for withdrawal

Measure	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. Transitional Tobacco Care Management (TTCM): TTCM 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: 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Overall Study Death	19	24
Overall Study Lost to Follow-up	141	141
Overall Study Withdrawal by Subject	26	20

Baseline Characteristics

Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Baseline characteristics by cohort

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	Total n=1409 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 13 • n=93 Participants	52 years STANDARD_DEVIATION 12 • n=4 Participants	52 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	391 Participants n=93 Participants	393 Participants n=4 Participants	784 Participants n=27 Participants
Sex: Female, Male Male	315 Participants n=93 Participants	310 Participants n=4 Participants	625 Participants n=27 Participants
Race/Ethnicity, Customized White non-Hispanic	539 Participants n=93 Participants	550 Participants n=4 Participants	1089 Participants n=27 Participants
Race/Ethnicity, Customized Black non-Hispanic	116 Participants n=93 Participants	100 Participants n=4 Participants	216 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	39 Participants n=93 Participants	43 Participants n=4 Participants	82 Participants n=27 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Other/unknown	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Cigarettes smoked per day, past 30 days	16 cigarettes/day STANDARD_DEVIATION 10 • n=93 Participants	17 cigarettes/day STANDARD_DEVIATION 11 • n=4 Participants	16 cigarettes/day STANDARD_DEVIATION 11 • n=27 Participants
Smoke 1st cigarette within 30 min of waking	547 Participants n=93 Participants	563 Participants n=4 Participants	1110 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months after hospital discharge

Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration <=10 ng/ml OR breath sample with a carbon monoxide concentration <=9 ppm.

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Tobacco Abstinence, Biochemically Confirmed	110 Participants	96 Participants

SECONDARY outcome

Timeframe: 1 month after hospital discharge

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Tobacco Abstinence, Self-report	291 Participants	246 Participants

SECONDARY outcome

Timeframe: 3 months after hospital discharge

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Tobacco Abstinence, Self-report	276 Participants	218 Participants

SECONDARY outcome

Timeframe: 6 months after hospital discharge

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Tobacco Abstinence, Self-report	234 Participants	202 Participants

SECONDARY outcome

Timeframe: 1 month after hospital discharge

Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Engagement in Cessation Treatment	489 Participants	369 Participants

SECONDARY outcome

Timeframe: 3 months after hospital discharge

Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Engagement in Cessation Treatment	434 Participants	319 Participants

SECONDARY outcome

Timeframe: 6 months follow-up

Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge

Outcome measures

Measure	Transitional Tobacco Care Management (TTCM) n=706 Participants 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. Transitional Tobacco Care Management (TTCM): TTCM 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: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.	eReferral to State Tobacco Quitline (QL) n=703 Participants 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. 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. Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge	120 Participants	91 Participants

Adverse Events

Transitional Tobacco Care Management (TTCM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 19 deaths

eReferral to State Tobacco Quitline (QL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Rigotti, MD

Massachusetts General Hospital

Phone: 617-724-3548

Email: nrigotti@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place