Trial Outcomes & Findings for Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (NCT NCT01714323)
NCT ID: NCT01714323
Last Updated: 2018-06-08
Results Overview
Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1359 participants
Primary outcome timeframe
6 months
Results posted on
2018-06-08
Participant Flow
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
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
677
|
680
|
|
Overall Study
COMPLETED
|
513
|
508
|
|
Overall Study
NOT COMPLETED
|
164
|
172
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Baseline characteristics by cohort
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
Total
n=1357 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=5 Participants
|
348 Participants
n=7 Participants
|
689 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
677 participants
n=5 Participants
|
680 participants
n=7 Participants
|
1357 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsCotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
Tobacco Abstinence - 6 Month Follow-up
|
105 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 monthsContinuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
Continuous Tobacco Abstinence
1 month follow-up
|
179 Participants
|
211 Participants
|
|
Continuous Tobacco Abstinence
3 month follow-up
|
122 Participants
|
147 Participants
|
|
Continuous Tobacco Abstinence
6 month follow-up
|
101 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
Point Prevalence Tobacco Abstinence
1 month follow-up
|
217 Participants
|
295 Participants
|
|
Point Prevalence Tobacco Abstinence
3 month follow-up
|
206 Participants
|
253 Participants
|
|
Point Prevalence Tobacco Abstinence
6 month follow-up
|
180 Participants
|
209 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 monthsSelf-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.
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
Duration of Tobacco Abstinence After Hospital Discharge
|
7 days
Interval 2.0 to 75.0
|
14 days
Interval 3.0 to 90.0
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 monthsUse 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).
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
Use of Smoking Cessation Treatment After Hospital Discharge
1 month follow-up
|
306 Participants
|
491 Participants
|
|
Use of Smoking Cessation Treatment After Hospital Discharge
3 month follow-up
|
404 Participants
|
554 Participants
|
|
Use of Smoking Cessation Treatment After Hospital Discharge
6 month follow-up
|
448 Participants
|
580 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsSelf-reported admission to a hospital in the 12 months after the index hospitalization.
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
All-cause Hospitalizations
|
224 hospital admissions
|
216 hospital admissions
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsDeath from any cause in the 6 months after hospital discharge
Outcome measures
| Measure |
Standard Care
n=677 Participants
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.
|
Sustained Care
n=680 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.
|
|---|---|---|
|
All-cause Mortality
|
14 Participants
|
13 Participants
|
Adverse Events
Standard Care
Serious events: 224 serious events
Other events: 0 other events
Deaths: 0 deaths
Sustained Care
Serious events: 216 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care
n=677 participants at risk
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.
|
Sustained Care
n=680 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Hospital Readmission
|
9.7%
66/677 • 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.
|
10.3%
70/680 • 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.
|
|
Blood and lymphatic system disorders
Hospital Readmission
|
2.8%
19/677 • 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.
|
0.59%
4/680 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospital Readmission
|
0.89%
6/677 • 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.
|
1.2%
8/680 • 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.
|
|
Cardiac disorders
Hospital Readmission
|
7.4%
50/677 • 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.
|
7.1%
48/680 • 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.
|
|
Skin and subcutaneous tissue disorders
Hospital Readmission
|
3.1%
21/677 • 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.
|
2.2%
15/680 • 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.
|
|
Endocrine disorders
Hospital Readmission
|
1.5%
10/677 • 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.
|
3.7%
25/680 • 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.
|
|
Eye disorders
Hospital Readmission
|
0.30%
2/677 • 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.
|
0.15%
1/680 • 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.
|
|
General disorders
Hospital Readmission
|
3.2%
22/677 • 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.
|
1.9%
13/680 • 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.
|
|
Infections and infestations
Hospital Readmission
|
2.2%
15/677 • 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.
|
1.0%
7/680 • 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.
|
|
Injury, poisoning and procedural complications
Hospital Readmission
|
6.5%
44/677 • 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.
|
4.6%
31/680 • 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.
|
|
Hepatobiliary disorders
Hospital Readmisson
|
3.0%
20/677 • 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.
|
3.2%
22/680 • 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.
|
|
Metabolism and nutrition disorders
Hospital Readmission
|
2.5%
17/677 • 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.
|
5.1%
35/680 • 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.
|
|
Musculoskeletal and connective tissue disorders
Hospital Readmission
|
2.2%
15/677 • 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.
|
1.2%
8/680 • 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.
|
|
Nervous system disorders
Hospital Readmission
|
1.3%
9/677 • 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.
|
2.5%
17/680 • 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.
|
|
Psychiatric disorders
Hospital Readmission
|
4.3%
29/677 • 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.
|
2.8%
19/680 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospital Readmission
|
3.8%
26/677 • 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.
|
4.3%
29/680 • 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.
|
|
Vascular disorders
Hospital Readmission
|
3.5%
24/677 • 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.
|
4.6%
31/680 • 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.
|
|
Cardiac disorders
Death
|
1.0%
7/677 • 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.
|
0.29%
2/680 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.15%
1/677 • 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.
|
0.59%
4/680 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/677 • 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.
|
0.15%
1/680 • 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.
|
|
Hepatobiliary disorders
Death
|
0.30%
2/677 • 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.
|
0.15%
1/680 • 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.
|
|
Infections and infestations
Death
|
0.30%
2/677 • 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.
|
0.59%
4/680 • 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.
|
|
Injury, poisoning and procedural complications
Death
|
0.30%
2/677 • 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.
|
0.15%
1/680 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place