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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| North Shore Medical Center | OTHER |
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Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a "teachable moment" for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions.
Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence.
Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.
Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Other | At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. |
|
| Sustained Care | Experimental | A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained Care | Behavioral | A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Abstinence - 6 Month Follow-up | Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Tobacco Abstinence | Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months. | 1 month, 3 months, 6 months |
| Point Prevalence Tobacco Abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Hospitalizations | Self-reported admission to a hospital in the 12 months after the index hospitalization. | 12 months |
| All-cause Mortality | Death from any cause in the 6 months after hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Rigotti, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| North Shore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31687769 | Derived | Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168. | |
| 30156578 | Derived | Streck JM, Chang Y, Tindle HA, Regan S, Park ER, Levy DE, Singer DE, Ylioja T, Rigotti NA. Smoking Cessation After Hospital Discharge: Factors Associated With Abstinence. J Hosp Med. 2018 Nov 1;13(11):774-778. doi: 10.12788/jhm.2997. Epub 2018 Aug 29. |
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1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).
Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. |
| FG001 | Sustained Care | A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling. Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. |
| 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 - 6 Month Follow-up | Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up | Posted | Count of Participants | Participants | 6 months |
|
1 year (hospital readmissions); 6 months (deaths)
Hospital admissions for 1 year after index hospitalization were obtained by chart review of admissions to the network of hospitals affiliated with Partners HealthCare and University of Pittsburgh Medical Center. Deaths in the first 6 months were systematically identified at patient assessments (1, 3, and 6 months). No systematic assessment of other adverse events during the trial was done due to the intervention's minimal risk.
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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 | Standard Care | At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Readmission | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Rigotti, MD | Massachusetts General Hospital | 617-724-4709 | nrigotti@partners.org |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. |
|
7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
| 1 month, 3 months, 6 months |
| Duration of Tobacco Abstinence After Hospital Discharge | Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred. | 1 month, 3 months, 6 months |
| Use of Smoking Cessation Treatment After Hospital Discharge | Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling). | 1 month, 3 months, 6 months |
| 6 months |
| Salem |
| Massachusetts |
| 01970 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| 29582077 | Derived | Rigotti NA, Chang Y, Tindle HA, Kalkhoran SM, Levy DE, Regan S, Kelley JHK, Davis EM, Singer DE. Association of E-Cigarette Use With Smoking Cessation Among Smokers Who Plan to Quit After a Hospitalization: A Prospective Study. Ann Intern Med. 2018 May 1;168(9):613-620. doi: 10.7326/M17-2048. Epub 2018 Mar 27. |
| 28616847 | Derived | Rigotti NA, Chang Y, Rosenfeld LC, Japuntich SJ, Park ER, Tindle HA, Levy DE, Reid ZZ, Streck J, Gomperts T, Kelley JHK, Singer DE. Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. J Gen Intern Med. 2017 Sep;32(9):1005-1013. doi: 10.1007/s11606-017-4085-z. Epub 2017 Jun 14. |
| 27647060 | Derived | Rigotti NA, Tindle HA, Regan S, Levy DE, Chang Y, Carpenter KM, Park ER, Kelley JH, Streck JM, Reid ZZ, Ylioja T, Reyen M, Singer DE. A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial. Am J Prev Med. 2016 Oct;51(4):597-608. doi: 10.1016/j.amepre.2016.04.005. |
| 25879193 | Derived | Reid ZZ, Regan S, Kelley JH, Streck JM, Ylioja T, Tindle HA, Chang Y, Levy DE, Park ER, Singer DE, Carpenter KM, Reyen M, Rigotti NA. Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial. BMC Public Health. 2015 Feb 7;15:109. doi: 10.1186/s12889-015-1484-0. |
| BG001 | Sustained Care | A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling. Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling. Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. |
|
|
|
| Secondary | Continuous Tobacco Abstinence | Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months. | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months |
|
|
|
|
| Secondary | Point Prevalence Tobacco Abstinence | 7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months |
|
|
|
|
| Secondary | Duration of Tobacco Abstinence After Hospital Discharge | Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred. | Posted | Median | Inter-Quartile Range | days | 1 month, 3 months, 6 months |
|
|
|
| Secondary | Use of Smoking Cessation Treatment After Hospital Discharge | Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling). | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months |
|
|
|
|
| Other Pre-specified | All-cause Hospitalizations | Self-reported admission to a hospital in the 12 months after the index hospitalization. | Posted | Number | hospital admissions | 12 months |
|
|
|
|
| Other Pre-specified | All-cause Mortality | Death from any cause in the 6 months after hospital discharge | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 224 |
| 677 |
| 0 |
| 677 |
| EG001 | Sustained Care | A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling. Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. | 216 | 680 | 0 | 680 |
| Hospital Readmission | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hospital Readmission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hospital Readmission | Cardiac disorders | Systematic Assessment |
|
| Hospital Readmission | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospital Readmission | Endocrine disorders | Systematic Assessment |
|
| Hospital Readmission | Eye disorders | Systematic Assessment |
|
| Hospital Readmission | General disorders | Systematic Assessment |
|
| Hospital Readmission | Infections and infestations | Systematic Assessment |
|
| Hospital Readmission | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospital Readmisson | Hepatobiliary disorders | Systematic Assessment |
|
| Hospital Readmission | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hospital Readmission | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospital Readmission | Nervous system disorders | Systematic Assessment |
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| Hospital Readmission | Psychiatric disorders | Systematic Assessment |
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| Hospital Readmission | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hospital Readmission | Vascular disorders | Systematic Assessment |
|
| Death | Cardiac disorders | Systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Death | Hepatobiliary disorders | Systematic Assessment |
|
| Death | Infections and infestations | Systematic Assessment |
|
| Death | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 6 month follow-up |
|
| 6 month follow-up |
|
| <0.01 |
| Superiority |
| This is for Month 6 | Chi-squared | <0.09 | Superiority |
| 6 month follow-up |
|