Smoking CessationNCT03452371
Hospital-based Patient Navigation and Smoking Cessation
A study testing Patient Navigation and Enhanced Traditional Care in people with Smoking Cessation, run by Boston Medical Center at 1 site in United States.
Trial summary
In a pilot randomized controlled trial (RCT), smokers hospitalized on the general internal medicine or family medicine service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation (PN). 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?
- Patient Navigation and Enhanced Traditional Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 4 Jun 2019
- Phase
- Interventional
- 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
- Hospitalized on the General Internal Medicine or Family Medicine service
- Have a primary care provider at BMC
- Smoked ≥1 cigarettes/day in the past month
- Must have plans to quit smoking
- Read, understand, speak English
- Possession of a telephone (home or cell)
- Able to consent
Who cannot join
- Cannot give informed consent or participate in counseling due to psychiatric or cognitive impairment or communication barrier
- Admitted to surgical, obstetric or psychiatric units
- Estimated life expectancy of <12 months
- Medical instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
In a pilot randomized controlled trial (RCT), smokers hospitalized on the general internal medicine or family medicine service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation (PN). Patients will be assessed at 3 months for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting. Medical charts will be reviewed to ascertain if a prescription for smoking cessation medications was sent to the participants' pharmacy (primary outcome), if participants received inpatient tobacco counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of mental health and substance use.
Read the detailed description
An Electronic Privacy Information Center(EPIC programmer who works with the Inpatient Tobacco Treatment Program will identify potential participants using electronic health record (EHR) data each week.
Eligible patients who are interested in the study and provide informed consent will be randomized and informed of the randomization assignment by the research assistant. We will stratify randomization by participants' response regarding their plan to quit smoking ("in the next month" or "more than a month from now"). A computer-generated sequence of random numbers will assign treatment groups. Participants will be randomized to one of two treatment arms: (1) standard of care, or (2) PN: a patient navigator to coordinate tobacco treatment with the smoker's outpatient healthcare team and address any underlying social determinants of health that are barriers to cessation (identified using a validated social determinants of health screening tool).
Assessments. A trained research assistant will administer these assessments either in-person or over the phone. The assessments require under 30 minutes to complete. The PI will also conduct an in-depth interview with the patient navigator to explore barriers to successful navigation. Outcome assessments will be conducted at baseline (prior to randomization) and at 3-months after randomization. Participants will be assessed at 3-months, for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting.
Enhanced Traditional Care: Participants randomized to this group will receive a resource card that has information on quitlines, Boston Medical Center (BMC) outpatient program number, and websites for smoking cessation.
Patient Navigation Intervention: This intervention is based on the Social Contextual Model, a multi-level approach to health education which stresses the influence of life experiences (e.g. stress and financial problems) and social relationships (e.g. social networks and family roles) on the practice of health behaviors. Participants randomized into this group will meet the trained navigator in person if she is available, or will be introduced by telephone. Participants will receive up to ten hours of patient navigation, in person or over the phone, over a three-month period. Patient navigation contacts will involve individual counseling to help the patient achieve abstinence from smoking. Navigators will also screen participants for social determinants of health which may be preventing them from quitting smoking, using an adapted version of a validated social determinants of health screening tool. Patient navigation intervention calls will use motivational interviewing (MI) strategies to do the following: (1) Assess stage of change for smoking cessation; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce or quit smoking; (3) Explore the patient's motivation to quit smoking, drawing on recent illness, financial situation, and family situation as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications (e.g. lack of trust, cost, misconceptions about treatment (e.g. that nicotine replacement therapy (NRT) is more harmful than cigarettes); (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.
Minimum navigation intervention dose: completion of social determinants of health screener and at least part of MI script (at least 1 item)
Navigator Training and Evaluation. A standard, validated motivational interviewing (MI) booster training program will be provided to one navigator. Training will include information about 1) tobacco dependence and treatment; and 2) barriers to treatment engagement among poor/minority patients. Our navigator will also be trained in MI. This additional training will take place over a half day and will focus on reviewing MI skills and delivery of the navigator intervention. MI skills will be reviewed through didactics, demonstrations, role-plays, and video. The navigator will be evaluated on both process (helpfulness, warmth, empathy), and content (intervention adherence). Following training the principal investigator (PI) will meet weekly with the navigator to ensure skill maintenance by reviewing audiotapes of intervention calls and providing corrective feedback.
Preserving Internal Validity/Treatment Fidelity, and Program Tracking. The intervention is manual-based. After each patient interaction, the navigator will complete a checklist of intervention components that were delivered. We will use these checklists to ensure that the intervention is delivered as intended, and to estimate intervention "dose" and treatment exposure. 5 participant interactions will be audio taped with permission from the participant. the PI will monitor tapes for protocol adherence.
Chart review. The research assistant will review participants' medical record to see if they have talked to their doctor about quitting smoking, if they have been prescribed medications to quit smoking, if they have attended a smoking cessation group at Boston Medical Center, if they received tobacco counseling from TTS, and if they have reduced the number of cigarettes or have quit smoking. We will collect data on mental health and substance use diagnoses. The investigators define mental health and substance use as the presence of diagnosed mental illness/substance use on the problem list/ annotations to problem list. the investigators will also determine whether participants have participated in any smoking cessation counseling sessions over the phone from the Massachusetts Quitworks Program.
- Conditions
- Smoking Cessation
- Being tested
- Patient Navigation, Enhanced Traditional Care
- Keywords
- Patient Navigation, Hospitalized smokers
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.
Enhanced Traditional CareBehavioural
Enhanced traditional care will include a resource card with information on quitlines, Boston Medical Center's (BMC's) Tobacco Treatment Center Program number, and websites for smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Traditional Care | Active comparator | Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support. Receives: Behavioral: Enhanced Traditional Care |
| Patient Navigation Intervention | Experimental | Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months. Receives: Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication
Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
Measured: Three months
Secondary outcomes (5)
Number of Participants With Self-reported Smoking Cessation
Self-report of 7-day point prevalence abstinence
Measured: Three months
Number of Participants With Utilization of Smoking Cessation Medication
self-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)
Measured: Three months
Number of Participants With Stage of Change for Smoking Cessation
Based on the Transtheoretical Model by Prochaska \& DiClemente. The stages of change are: precontemplation, contemplation, preparation, action, maintenance, and relapse.
Defined as moving from pre-contemplation to contemplation, or contemplation to preparation stage.
Measured: Three months
Mean Fagerstrom Test Score for Nicotine Dependence
Standard validated 6 item instrument for assessing the intensity of addiction to nicotine. The 3 yes/no items are scored from 0 to 1. The 3 multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Measured: Three months
Use of Other Tobacco Treatment Support
Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start4 Jun 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
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 (8)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Sponsor
- Investigators
- Karen Lasser, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452371
- Sponsor's protocol ID
- H-37040
- Other IDs
- 1UL1TR001430
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2018
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lasser KE, Quintiliani LM, Truong V, Xuan Z, Murillo J, Jean C, Pbert L. Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1798-1807. doi: 10.1001/jamainternmed.2017.4372.
PubMed 29084312Lasser KE, Kenst KS, Quintiliani LM, Wiener RS, Murillo J, Pbert L, Xuan Z, Bowen DJ. Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial. J Ethn Subst Abuse. 2013;12(4):374-90. doi: 10.1080/15332640.2013.819311.
PubMed 24215228Kendzor DE, Businelle MS, Poonawalla IB, Cuate EL, Kesh A, Rios DM, Ma P, Balis DS. Financial incentives for abstinence among socioeconomically disadvantaged individuals in smoking cessation treatment. Am J Public Health. 2015 Jun;105(6):1198-205. doi: 10.2105/AJPH.2014.302102. Epub 2014 Nov 13.
PubMed 25393172Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. doi: 10.2105/ajph.94.2.230.
PubMed 14759932Borrelli B, McQuaid EL, Novak SP, Hammond SK, Becker B. Motivating Latino caregivers of children with asthma to quit smoking: a randomized trial. J Consult Clin Psychol. 2010 Feb;78(1):34-43. doi: 10.1037/a0016932.
PubMed 20099948Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
PubMed 17766528Prochaska J, Redding C, Evers K. The Transtheoretical Model and Stages of Change. Health Behavior and Health Education: Theory, Research, and Practice.. Glanz K, Lewis FM, Rimer BK, editors. San Francisco: Jossey-Bass; 1997
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03452371
- Acronym / sponsor ID
- H-37040
- Conditions
- Smoking Cessation
- Keywords
- Patient Navigation, Hospitalized smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a pilot randomized controlled trial (RCT), smokers hospitalized on the general internal medicine or family medicine service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation (PN). Patients will be assessed at 3 months for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting. Medical charts will be reviewed to ascertain if a prescription for smoking cessation medications was sent to the participants' pharmacy (primary outcome), if participants received inpatient tobacco counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of mental health and substance use.
Detailed description
An Electronic Privacy Information Center(EPIC programmer who works with the Inpatient Tobacco Treatment Program will identify potential participants using electronic health record (EHR) data each week.
Eligible patients who are interested in the study and provide informed consent will be randomized and informed of the randomization assignment by the research assistant. We will stratify randomization by participants' response regarding their plan to quit smoking ("in the next month" or "more than a month from now"). A computer-generated sequence of random numbers will assign treatment groups. Participants will be randomized to one of two treatment arms: (1) standard of care, or (2) PN: a patient navigator to coordinate tobacco treatment with the smoker's outpatient healthcare team and address any underlying social determinants of health that are barriers to cessation (identified using a validated social determinants of health screening tool).
Assessments. A trained research assistant will administer these assessments either in-person or over the phone. The assessments require under 30 minutes to complete. The PI will also conduct an in-depth interview with the patient navigator to explore barriers to successful navigation. Outcome assessments will be conducted at baseline (prior to randomization) and at 3-months after randomization. Participants will be assessed at 3-months, for self-report of quitting, use of smoking cessation medications, and use of counseling in the outpatient setting.
Enhanced Traditional Care: Participants randomized to this group will receive a resource card that has information on quitlines, Boston Medical Center (BMC) outpatient program number, and websites for smoking cessation.
Patient Navigation Intervention: This intervention is based on the Social Contextual Model, a multi-level approach to health education which stresses the influence of life experiences (e.g. stress and financial problems) and social relationships (e.g. social networks and family roles) on the practice of health behaviors. Participants randomized into this group will meet the trained navigator in person if she is available, or will be introduced by telephone. Participants will receive up to ten hours of patient navigation, in person or over the phone, over a three-month period. Patient navigation contacts will involve individual counseling to help the patient achieve abstinence from smoking. Navigators will also screen participants for social determinants of health which may be preventing them from quitting smoking, using an adapted version of a validated social determinants of health screening tool. Patient navigation intervention calls will use motivational interviewing (MI) strategies to do the following: (1) Assess stage of change for smoking cessation; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce or quit smoking; (3) Explore the patient's motivation to quit smoking, drawing on recent illness, financial situation, and family situation as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications (e.g. lack of trust, cost, misconceptions about treatment (e.g. that nicotine replacement therapy (NRT) is more harmful than cigarettes); (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.
Minimum navigation intervention dose: completion of social determinants of health screener and at least part of MI script (at least 1 item)
Navigator Training and Evaluation. A standard, validated motivational interviewing (MI) booster training program will be provided to one navigator. Training will include information about 1) tobacco dependence and treatment; and 2) barriers to treatment engagement among poor/minority patients. Our navigator will also be trained in MI. This additional training will take place over a half day and will focus on reviewing MI skills and delivery of the navigator intervention. MI skills will be reviewed through didactics, demonstrations, role-plays, and video. The navigator will be evaluated on both process (helpfulness, warmth, empathy), and content (intervention adherence). Following training the principal investigator (PI) will meet weekly with the navigator to ensure skill maintenance by reviewing audiotapes of intervention calls and providing corrective feedback.
Preserving Internal Validity/Treatment Fidelity, and Program Tracking. The intervention is manual-based. After each patient interaction, the navigator will complete a checklist of intervention components that were delivered. We will use these checklists to ensure that the intervention is delivered as intended, and to estimate intervention "dose" and treatment exposure. 5 participant interactions will be audio taped with permission from the participant. the PI will monitor tapes for protocol adherence.
Chart review. The research assistant will review participants' medical record to see if they have talked to their doctor about quitting smoking, if they have been prescribed medications to quit smoking, if they have attended a smoking cessation group at Boston Medical Center, if they received tobacco counseling from TTS, and if they have reduced the number of cigarettes or have quit smoking. We will collect data on mental health and substance use diagnoses. The investigators define mental health and substance use as the presence of diagnosed mental illness/substance use on the problem list/ annotations to problem list. the investigators will also determine whether participants have participated in any smoking cessation counseling sessions over the phone from the Massachusetts Quitworks Program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Traditional Care | Active comparator | Behavioral: Enhanced Traditional CareParticipants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support. |
| Patient Navigation Intervention | Experimental | Behavioral: Patient NavigationParticipants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Hospitalized on the General Internal Medicine or Family Medicine service
- Have a primary care provider at BMC
- Smoked ≥1 cigarettes/day in the past month
- Must have plans to quit smoking
Key exclusion criteria (4 listed)
- Cannot give informed consent or participate in counseling due to psychiatric or cognitive impairment or communication barrier
- Admitted to surgical, obstetric or psychiatric units
- Estimated life expectancy of <12 months
- Medical instability
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 |
|---|---|---|
| Patient NavigationNavigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing. | Behavioural | Patient Navigation Intervention |
| Enhanced Traditional CareEnhanced traditional care will include a resource card with information on quitlines, Boston Medical Center's (BMC's) Tobacco Treatment Center Program number, and websites for smoking cessation. | Behavioural | Enhanced Traditional Care |
Primary outcome
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication
Time frame: Three months
Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
5 secondary outcomes
Number of Participants With Self-reported Smoking Cessation
Time frame: Three months
Number of Participants With Utilization of Smoking Cessation Medication
Time frame: Three months
Number of Participants With Stage of Change for Smoking Cessation
Time frame: Three months
Mean Fagerstrom Test Score for Nicotine Dependence
Time frame: Three months
Use of Other Tobacco Treatment Support
Time frame: Three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29084312Lasser KE, Quintiliani LM, Truong V, Xuan Z, Murillo J, Jean C, Pbert L. Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1798-1807. doi: 10.1001/jamainternmed.2017.4372.
- Background: PubMed 24215228Lasser KE, Kenst KS, Quintiliani LM, Wiener RS, Murillo J, Pbert L, Xuan Z, Bowen DJ. Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial. J Ethn Subst Abuse. 2013;12(4):374-90. doi: 10.1080/15332640.2013.819311.
- Background: PubMed 25393172Kendzor DE, Businelle MS, Poonawalla IB, Cuate EL, Kesh A, Rios DM, Ma P, Balis DS. Financial incentives for abstinence among socioeconomically disadvantaged individuals in smoking cessation treatment. Am J Public Health. 2015 Jun;105(6):1198-205. doi: 10.2105/AJPH.2014.302102. Epub 2014 Nov 13.
- Background: PubMed 14759932Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. doi: 10.2105/ajph.94.2.230.
- Background: PubMed 20099948Borrelli B, McQuaid EL, Novak SP, Hammond SK, Becker B. Motivating Latino caregivers of children with asthma to quit smoking: a randomized trial. J Consult Clin Psychol. 2010 Feb;78(1):34-43. doi: 10.1037/a0016932.
- Background: PubMed 17766528Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
- BackgroundProchaska J, Redding C, Evers K. The Transtheoretical Model and Stages of Change. Health Behavior and Health Education: Theory, Research, and Practice.. Glanz K, Lewis FM, Rimer BK, editors. San Francisco: Jossey-Bass; 1997
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- 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.
Karen Lasser, MD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and Enhanced Traditional Care in people with Smoking Cessation, run by Boston Medical Center at 1 site 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 8 inclusion and 4 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2020). 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?
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication (time frame: Three months). 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 NCT03452371, which also lists 8 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 31 Mar 2020.