Trial · NCT01714323
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
NCT01714323, Not applicable, Completed, Massachusetts General Hospital; results first posted 2018-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers. Trials, record NCT01714323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01714323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
- NCT number
- NCT01714323
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,359 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder
- Interventions
- Sustained Care, Standard Care
- First posted
- 2012-10-25
- Last updated
- 2018-06-08
- Results first posted
- 2018-06-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tobacco Abstinence - 6 Month Follow-up | 6 months | Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up |
| Secondary | Continuous Tobacco Abstinence | 1 month, 3 months, 6 months | Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months. |
| Secondary | Point Prevalence Tobacco Abstinence | 1 month, 3 months, 6 months | 7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report |
| Secondary | Duration of Tobacco Abstinence After Hospital Discharge | 1 month, 3 months, 6 months | 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. |
| Secondary | Use of Smoking Cessation Treatment After Hospital Discharge | 1 month, 3 months, 6 months | 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). |
| Other | All-cause Hospitalizations | 12 months | Self-reported admission to a hospital in the 12 months after the index hospitalization. |
| Other | All-cause Mortality | 6 months | Death from any cause in the 6 months after hospital discharge |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tobacco Abstinence - 6 Month Follow-up | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Continuous Tobacco Abstinence | 1 month, 3 months, 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Point Prevalence Tobacco Abstinence | 1 month, 3 months, 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Tobacco Abstinence After Hospital Discharge | 1 month, 3 months, 6 months | days | MEDIAN | |
| SECONDARY | Use of Smoking Cessation Treatment After Hospital Discharge | 1 month, 3 months, 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | All-cause Hospitalizations | 12 months | hospital admissions | NUMBER | |
| OTHER_PRE_SPECIFIED | All-cause Mortality | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tobacco Abstinence - 6 Month Follow-up | Standard Care | 105 | Participants | ||
| Tobacco Abstinence - 6 Month Follow-up | Sustained Care | 113 | Participants | ||
| Continuous Tobacco Abstinence | Standard Care | 1 month follow-up | 179 | Participants | |
| Continuous Tobacco Abstinence | Sustained Care | 1 month follow-up | 211 | Participants | |
| Continuous Tobacco Abstinence | Standard Care | 3 month follow-up | 122 | Participants | |
| Continuous Tobacco Abstinence | Sustained Care | 3 month follow-up | 147 | Participants | |
| Continuous Tobacco Abstinence | Standard Care | 6 month follow-up | 101 | Participants | |
| Continuous Tobacco Abstinence | Sustained Care | 6 month follow-up | 121 | Participants | |
| Point Prevalence Tobacco Abstinence | Standard Care | 1 month follow-up | 217 | Participants | |
| Point Prevalence Tobacco Abstinence | Sustained Care | 1 month follow-up | 295 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Care | 677 | |
| Overall Study | STARTED | Sustained Care | 680 | |
| Overall Study | COMPLETED | Standard Care | 513 | |
| Overall Study | COMPLETED | Sustained Care | 508 | |
| Overall Study | NOT COMPLETED | Standard Care | 164 | |
| Overall Study | NOT COMPLETED | Sustained Care | 172 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospital Readmission | Gastrointestinal disorders | Standard Care | 66 | 677 | |
| serious | Hospital Readmission | Gastrointestinal disorders | Sustained Care | 70 | 680 | |
| serious | Hospital Readmission | Blood and lymphatic system disorders | Standard Care | 19 | 677 | |
| serious | Hospital Readmission | Blood and lymphatic system disorders | Sustained Care | 4 | 680 | |
| serious | Hospital Readmission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard Care | 6 | 677 | |
| serious | Hospital Readmission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sustained Care | 8 | 680 | |
| serious | Hospital Readmission | Cardiac disorders | Standard Care | 50 | 677 | |
| serious | Hospital Readmission | Cardiac disorders | Sustained Care | 48 | 680 | |
| serious | Hospital Readmission | Skin and subcutaneous tissue disorders | Standard Care | 21 | 677 | |
| serious | Hospital Readmission | Skin and subcutaneous tissue disorders | Sustained Care | 15 | 680 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Care | ||
| Total, all-cause mortality | Sustained Care | ||
| Total, other adverse events | Standard Care | 0 | 677 |
| Total, other adverse events | Sustained Care | 0 | 680 |
| Total, serious adverse events | Standard Care | 224 | 677 |
| Total, serious adverse events | Sustained Care | 216 | 680 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL111821 | Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers | RIGOTTI, NANCY A; TINDLE, HILARY A. | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2021 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sustained Care vs Standard Care: Tobacco Abstinence - 6 Month Follow-up | Trial comparisons |
| Sustained Care vs Standard Care: All-cause Mortality | Trial comparisons |
| Sustained Care vs Standard Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01714323
GET https://conductscience.org/api/trials/v1/NCT01714323/results?page=2