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Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2)

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ClinicalTrials.gov Identifier: NCT01714323
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
University of Pittsburgh
North Shore Medical Center
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cigarette Smoking
Tobacco Smoking
Tobacco Use Disorder
Interventions Behavioral: Sustained Care
Behavioral: Standard Care
Enrollment 1359
Recruitment Details 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
Pre-assignment Details 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).
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 677 680
Completed 513 508
Not Completed 164 172
Arm/Group Title Standard Care Sustained Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 677 680 1357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 677 participants 680 participants 1357 participants
49.8  (12.4) 49.6  (12.8) 49.7  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 677 participants 680 participants 1357 participants
Female
336
  49.6%
332
  48.8%
668
  49.2%
Male
341
  50.4%
348
  51.2%
689
  50.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 677 participants 680 participants 1357 participants
677 680 1357
1.Primary Outcome
Title Tobacco Abstinence - 6 Month Follow-up
Hide Description Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Count of Participants
Unit of Measure: Participants
105
  15.5%
113
  16.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow–Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.84 to 1.37
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Continuous Tobacco Abstinence
Hide Description Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
Time Frame 1 month, 3 months, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Count of Participants
Unit of Measure: Participants
1 month follow-up
179
  26.4%
211
  31.0%
3 month follow-up
122
  18.0%
147
  21.6%
6 month follow-up
101
  14.9%
121
  17.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Point Prevalence Tobacco Abstinence
Hide Description 7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
Time Frame 1 month, 3 months, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Count of Participants
Unit of Measure: Participants
1 month follow-up
217
  32.1%
295
  43.4%
3 month follow-up
206
  30.4%
253
  37.2%
6 month follow-up
180
  26.6%
209
  30.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments This compares at Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments This is analysis for Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments This is for Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.09
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Duration of Tobacco Abstinence After Hospital Discharge
Hide Description 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.
Time Frame 1 month, 3 months, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Median (Inter-Quartile Range)
Unit of Measure: days
7
(2 to 75)
14
(3 to 90)
5.Secondary Outcome
Title Use of Smoking Cessation Treatment After Hospital Discharge
Hide Description 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).
Time Frame 1 month, 3 months, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Count of Participants
Unit of Measure: Participants
1 month follow-up
306
  45.2%
491
  72.2%
3 month follow-up
404
  59.7%
554
  81.5%
6 month follow-up
448
  66.2%
580
  85.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.
Method Chi-squared
Comments [Not Specified]
6.Other Pre-specified Outcome
Title All-cause Hospitalizations
Hide Description Self-reported admission to a hospital in the 12 months after the index hospitalization.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Number
Unit of Measure: hospital admissions
224 216
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Other Pre-specified Outcome
Title All-cause Mortality
Hide Description Death from any cause in the 6 months after hospital discharge
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 677 680
Measure Type: Count of Participants
Unit of Measure: Participants
14
   2.1%
13
   1.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care, Sustained Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 1 year (hospital readmissions); 6 months (deaths)
Adverse Event Reporting Description 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.
 
Arm/Group Title Standard Care Sustained Care
Hide Arm/Group Description

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.

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
Standard Care Sustained Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Care Sustained Care
Affected / at Risk (%) Affected / at Risk (%)
Total   224/677 (33.09%)   216/680 (31.76%) 
Blood and lymphatic system disorders     
Hospital Readmission   19/677 (2.81%)  4/680 (0.59%) 
Cardiac disorders     
Hospital Readmission   50/677 (7.39%)  48/680 (7.06%) 
Death   7/677 (1.03%)  2/680 (0.29%) 
Endocrine disorders     
Hospital Readmission   10/677 (1.48%)  25/680 (3.68%) 
Eye disorders     
Hospital Readmission   2/677 (0.30%)  1/680 (0.15%) 
Gastrointestinal disorders     
Hospital Readmission   66/677 (9.75%)  70/680 (10.29%) 
General disorders     
Hospital Readmission   22/677 (3.25%)  13/680 (1.91%) 
Hepatobiliary disorders     
Hospital Readmisson   20/677 (2.95%)  22/680 (3.24%) 
Death   2/677 (0.30%)  1/680 (0.15%) 
Infections and infestations     
Hospital Readmission   15/677 (2.22%)  7/680 (1.03%) 
Death   2/677 (0.30%)  4/680 (0.59%) 
Injury, poisoning and procedural complications     
Hospital Readmission   44/677 (6.50%)  31/680 (4.56%) 
Death   2/677 (0.30%)  1/680 (0.15%) 
Metabolism and nutrition disorders     
Hospital Readmission   17/677 (2.51%)  35/680 (5.15%) 
Musculoskeletal and connective tissue disorders     
Hospital Readmission   15/677 (2.22%)  8/680 (1.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hospital Readmission   6/677 (0.89%)  8/680 (1.18%) 
Death   1/677 (0.15%)  4/680 (0.59%) 
Nervous system disorders     
Hospital Readmission   9/677 (1.33%)  17/680 (2.50%) 
Psychiatric disorders     
Hospital Readmission   29/677 (4.28%)  19/680 (2.79%) 
Respiratory, thoracic and mediastinal disorders     
Hospital Readmission   26/677 (3.84%)  29/680 (4.26%) 
Death   0/677 (0.00%)  1/680 (0.15%) 
Skin and subcutaneous tissue disorders     
Hospital Readmission   21/677 (3.10%)  15/680 (2.21%) 
Vascular disorders     
Hospital Readmission   24/677 (3.55%)  31/680 (4.56%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care Sustained Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/677 (0.00%)   0/680 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nancy Rigotti, MD
Organization: Massachusetts General Hospital
Phone: 617-724-4709
Responsible Party: Nancy A. Rigotti, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01714323     History of Changes
Other Study ID Numbers: 1R01HL111821 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2012
First Posted: October 25, 2012
Results First Submitted: November 23, 2016
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018