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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
| Vanderbilt University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Experimental | 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. |
|
| eReferral to State Tobacco Quitline (QL) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transitional Tobacco Care Management (TTCM) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Abstinence, Biochemically Confirmed | 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. | 6 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | 1 month after hospital discharge |
| Tobacco Abstinence, Self-report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Rigotti, MD | Massachusetts General Hospital | Principal Investigator |
| Hilary A Tindle, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| University of Pittsburgh Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37209421 | Derived | Lee SS, Chang Y, Rigotti NA, Singer DE, Levy DE, Tyndale RF, Davis EM, Freiberg MS, King S, Wells QS, Tindle HA. Can Treatment Support Mitigate Nicotine Metabolism-Based Disparities in Smoking Abstinence? Secondary Analysis of the Helping HAND 4 Trial. Nicotine Tob Res. 2023 Aug 19;25(9):1575-1584. doi: 10.1093/ntr/ntad079. | |
| 35759282 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tobacco Abstinence, Biochemically Confirmed | 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. | Posted | Count of Participants | Participants | 6 months after hospital discharge |
|
6 months
Serious adverse events and other (not including serious) adverse events were not monitored or systematically assessed in this trial. However, when attempting to conduct follow-up assessments, study staff learned of some deaths of study participants, usually from a family member or the electronic health record. We are able to report the number of deaths of participants that we learned about during the routine follow-up procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Rigotti, MD | Massachusetts General Hospital | 617-724-3548 | nrigotti@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2020 | Apr 6, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| eReferral to State Tobacco Quitline (QL) | 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 | Drug | Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient. |
|
Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). |
| 3 months after hospital discharge |
| Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | 6 months after hospital discharge |
| Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment. | 1 month after hospital discharge |
| Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment | 3 months after hospital discharge |
| Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | 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 | 6 months follow-up |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| Rigotti NA, Chang Y, Davis EM, Regan S, Levy DE, Ylioja T, Kelley JHK, Notier AE, Gilliam K, Douaihy AB, Singer DE, Tindle HA. Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial. JAMA Intern Med. 2022 Aug 1;182(8):814-824. doi: 10.1001/jamainternmed.2022.2300. |
| 32299470 | Derived | Rigotti NA, Schnitzer K, Davis EM, Regan S, Chang Y, Kelley JHK, Notier AE, Gilliam K, Douaihy A, Levy DE, Singer DE, Tindle HA. Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial. Trials. 2020 Apr 16;21(1):336. doi: 10.1186/s13063-020-04257-7. |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cigarettes smoked per day, past 30 days | Mean | Standard Deviation | cigarettes/day |
|
| Smoke 1st cigarette within 30 min of waking | Measure of nicotine dependence. Smoking within 30 minutes of waking is associated with higher nicotine dependence. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
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| Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | Posted | Count of Participants | Participants | 3 months after hospital discharge |
|
|
|
|
| Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | Posted | Count of Participants | Participants | 6 months after hospital discharge |
|
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|
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| Secondary | Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment. | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
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| Secondary | Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment | Posted | Count of Participants | Participants | 3 months after hospital discharge |
|
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| Secondary | Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | 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 | Posted | Count of Participants | Participants | 6 months follow-up |
|
|
|
|
| 19 |
| 706 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 24 | 703 | 0 | 0 | 0 | 0 |
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