Smoking CessationPhase 4HH4NCT03603496
Post-Discharge Smoking Cessation Strategies: Helping HAND 4
A Phase 4 study testing Transitional Tobacco Care Management (TTCM), eReferral to State Tobacco Quitline (QL) and Nicotine replacement therapy in people with Smoking Cessation, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Transitional Tobacco Care Management (TTCM), eReferral to State Tobacco Quitline (QL) and Nicotine replacement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,416 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2018to 17 Nov 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
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.
Read the detailed 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.
- Conditions
- Smoking Cessation
- Being tested
- Transitional Tobacco Care Management (TTCM), eReferral to State Tobacco Quitline (QL), Nicotine replacement therapy
- Keywords
- Tobacco, Cessation, Hospitalization, eReferral, Interactive Voice Response, Tobacco Quitline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Tobacco Care Management (TTCM)Behavioural
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.
eReferral to State Tobacco Quitline (QL)Behavioural
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 therapyDrug
Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transitional Tobacco Care Management (TTCM); Drug: Nicotine replacement therapy |
| 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. Receives: Behavioral: eReferral to State Tobacco Quitline (QL); Drug: Nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after hospital discharge
Secondary outcomes (6)
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).
Measured: 1 month 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Sep 2018
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Nancy A. Rigotti, Massachusetts General Hospital
- Investigators
- Nancy A Rigotti, MD, Principal investigator, Massachusetts General HospitalHilary A Tindle, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603496
- Sponsor's protocol ID
- 2017P000774/PHS
- Acronym
- HH4
- Status last verified
- May 2022
- First submitted
- 18 Jul 2018
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37209421Rigotti 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.
PubMed 35759282Rigotti 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.
PubMed 32299470
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
- ClinicalTrials.gov ID
- NCT03603496
- Acronym / sponsor ID
- HH4 / 2017P000774/PHS
- Conditions
- Smoking Cessation
- Keywords
- Tobacco, Cessation, Hospitalization, eReferral, Interactive Voice Response, Tobacco Quitline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Vanderbilt University Medical Center
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Experimental | Behavioral: Transitional Tobacco Care Management (TTCM), Drug: Nicotine replacement therapyTTCM 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 | Behavioral: eReferral to State Tobacco Quitline (QL), Drug: Nicotine replacement therapyReferral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Transitional Tobacco Care Management (TTCM) |
| 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. | Behavioural | eReferral to State Tobacco Quitline (QL) |
| Nicotine replacement therapyUp to 8 weeks of nicotine replacement therapy provided at no cost to the patient. | Drug | Transitional Tobacco Care Management (TTCM), eReferral to State Tobacco Quitline (QL) |
Primary outcome
Tobacco Abstinence, Biochemically Confirmed
Time frame: 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.
6 secondary outcomes
Tobacco Abstinence, Self-report
Time frame: 1 month after hospital discharge
Tobacco Abstinence, Self-report
Time frame: 3 months after hospital discharge
Tobacco Abstinence, Self-report
Time frame: 6 months after hospital discharge
Engagement in Cessation Treatment
Time frame: 1 month after hospital discharge
Engagement in Cessation Treatment
Time frame: 3 months after hospital discharge
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge
Time frame: 6 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37209421Lee 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.
- Derived from this study: PubMed 35759282Rigotti 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.
- Derived from this study: PubMed 32299470Rigotti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Rigotti, MD principal investigator
Massachusetts General Hospital
Hilary A Tindle, MD, MPH principal investigator
Vanderbilt University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transitional Tobacco Care Management (TTCM), eReferral to State Tobacco Quitline (QL) and Nicotine replacement therapy in people with Smoking Cessation, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Abstinence, Biochemically Confirmed (time frame: 6 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603496, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.