Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252902
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2005-11-11
Brief Title:
Emergency Department Initiated Tobacco Treatment EDITT
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Emergency Department Initiated Tobacco Treatment EDITT
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to refine the intervention protocols for two ED-initiated tobacco interventions and to assess the magnitude of the effect size that can be expected We expect the intervention groups to have greater sustained abstinence point-prevalence abstinence and motivation to change when compared to the treatment as usual group at 1- and 3-month follow-up
Detailed Description:
Most surveys of emergency physicians indicate that smoking cessation counseling rarely occurs in routine clinical practice Prochazka and colleagues 1996 studied 196 members of the Colorado Chapter of the American College of Emergency Physicians and found that only 27 reported routinely asking patients to quit smoking We conducted a similar survey study and found that only 19 of emergency physicians practicing in an urban teaching hospital reported that they routinely counseled their tobacco using patients to quit A study of 63 adult smokers presenting to the ED with symptoms of acute respiratory illness found that only 9 were offered any assistance with quitting Bock et al 2001 Clearly more research was needed to investigate smoking interventions initiated in the ED
Currently not much is known about how best to intervene with smokers in the ED This proposal describes a pilot study designed to explore two interventions Research that expands our knowledge of ED-initiated tobacco interventions has tremendous public health potential especially for the under-served populations that are over-represented in the ED patient populationThis study is designed primarily to yield effects size parameters so a larger RCT can be planned For this reason it is not powered specifically to detect a given difference but rather simply to provide an idea of the size of the effect so we can determine how many subjects would be needed in a future trial in order to demonstrate statistical significance and clinical utility It will also be used to refine the study design protocols and treatment manuals for the future trial
This study will be a randomized single-blind controlled trial that will compared two types of ED-initiated tobacco treatment to treatment-as-usual 75 ED patients who meet all inclusion and exclusion criteria will be randomly assigned to one of three groups using a 221 ratio Group One Enhanced Care n30 Group Two Dynamic Referral n30 or Group Three Clinic Referral n15 This assignment ratio is being used to maximize experience with the treatments The two interventions will be delivered by trained counselors and are described below Baseline measures of smoking and other related variables will be taken during the ED visit An interviewer blind to study group assignment will conduct follow-up assessments via telephone at 1- and 3-months after the ED visit We expect a 25 attrition yielding follow-up data at 3-months on 23 23 and 11 patients respectively for each Group
Primary outcomes will include sustained abstinence from the ED visit to the follow-up time periods and 7-day point prevalence abstinence Secondary outcomes will be presence of a quit attempt 24 hours and readiness to change
Currently not much is known about how best to intervene with smokers in the ED This proposal describes a pilot study designed to explore two interventions Research that expands our knowledge of ED-initiated tobacco interventions has tremendous public health potential especially for the under-served populations that are over-represented in the ED patient populationThis study is designed primarily to yield effects size parameters so a larger RCT can be planned For this reason it is not powered specifically to detect a given difference but rather simply to provide an idea of the size of the effect so we can determine how many subjects would be needed in a future trial in order to demonstrate statistical significance and clinical utility It will also be used to refine the study design protocols and treatment manuals for the future trial
This study will be a randomized single-blind controlled trial that will compared two types of ED-initiated tobacco treatment to treatment-as-usual 75 ED patients who meet all inclusion and exclusion criteria will be randomly assigned to one of three groups using a 221 ratio Group One Enhanced Care n30 Group Two Dynamic Referral n30 or Group Three Clinic Referral n15 This assignment ratio is being used to maximize experience with the treatments The two interventions will be delivered by trained counselors and are described below Baseline measures of smoking and other related variables will be taken during the ED visit An interviewer blind to study group assignment will conduct follow-up assessments via telephone at 1- and 3-months after the ED visit We expect a 25 attrition yielding follow-up data at 3-months on 23 23 and 11 patients respectively for each Group
Primary outcomes will include sustained abstinence from the ED visit to the follow-up time periods and 7-day point prevalence abstinence Secondary outcomes will be presence of a quit attempt 24 hours and readiness to change
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DA-16698-01 | None | None | None |