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Tobacco DependenceSTTEPSNCT01839903

System Based Tracking and Treatment for Emergency Patients Who Smoke: STTEPS

A study testing EDIS and Care as usual in people with Tobacco Dependence, run by The Miriam Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Emergency Departments (EDs) are a critical component of the U.S. healthcare system, treating over 119 million patients each year. While EDs have historically neglected tobacco control efforts, several recent studies have examined the feasibility and efficacy of implementing tobacco cessation in the ED. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Dependence
What is being tested?
EDIS and Care as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
2 sitesUnited States
Study dates
19 Aug 2011to 30 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

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

  • Admitted to emergency department with sub-critical illness or injury
  • be 18 years of age or older,
  • smoke 3 or more cigarettes daily for the past 3 months or longer
  • English speaking
  • be reachable by telephone,
  • agree to participate in the study and be available for follow-up assessments

Who cannot join

  • altered mental status or are brought to the ED for treatment of alcohol or other drug ingestion or psychiatric illness or are taking psychoactive medications
  • currently using smokeless tobacco

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Massachusetts Medical School

    Worcester, Massachusetts

Other trials in United States

About this study

Emergency Departments (EDs) are a critical component of the U.S. healthcare system, treating over 119 million patients each year. While EDs have historically neglected tobacco control efforts, several recent studies have examined the feasibility and efficacy of implementing tobacco cessation in the ED. Work by our research team and others, has shown that tobacco treatment is both feasible and effective in the ED setting.

Effective, evidence-based interventions for treating tobacco dependence have also been codified in the United States Public Health Service guidelines. Even brief interventions delivered by physicians and other healthcare providers can produce significant increases in cessation across diverse clinical settings (e.g., outpatient clinics, surgery units, EDs), and patient groups (cardiac, respiratory, general admissions). However, in clinical practice, delivery of tobacco interventions is inconsistent at best, particularly in non-primary care settings.

Read more

This translational study uses an existing Emergency Department Information System (EDIS), to facilitate the identification of smokers and to enhance the provision of smoking cessation intervention materials and pharmacological adjuncts for patients receiving treatment in the ED. The EDIS tracks the geographic and chronologic progression of patients through the ED and contains triage and nursing notes, lab values, radiology reports and links to images, vital signs, embedded printable discharge instructions, and fax links to primary care provider (PCP) offices.

Following recruitment of a baseline (care-as-usual) cohort (Step 1), the investigators will provide training to ED physicians and staff to improve the identification and treatment of smokers. Following Step 1, the investigators will make adaptations to the EDIS system that include smoking status tracking, tobacco treatment prompts and medication information panels for the emergency treating physician, and links to printable discharge instructions, quit-smoking medication information and referral to a pro-active phone follow-up counseling for enrolled smokers. A second cohort of participants (Step 2) will be enrolled after implementation is complete. Contemporaneous with Steps 1 and 2, participant cohorts will be recruited at a control site (UMass Medical) to control for potential effects of historical trends. This study represents a comprehensive systems-based translation of empirically supported tobacco treatment built into a widely used patient tracking platform (MedHost) maximizing the probability of developing a sustainable tobacco intervention that can be readily disseminated.

Specific Aims A.1. To test the incremental efficacy of a modified Emergency Department Information System (EDIS) "MedHost", using a multiple-cohort design implemented in 2 steps. Two recruitment phases (baseline/care as usual and full implementation) will be used to assess the impact of EDIS enhancements on rates of identification and treatment of ED patients who smoke. The primary outcome is the difference in six-month abstinence between those recruited prior to program implementation (Baseline) versus those recruited when the program is fully implemented (Step 2). H1) Smokers enrolled during Step 2 at RIH will show significantly greater cessation at month 6 compared Step 1 and control site participants.

A.2. To compare rates of smoker identification, physician intervention and follow up care for smoking cessation and use of quit-smoking medications among ED patients recruited before and after EDIS modification. H2) Compared to Step 1 and the control site, Step 2 will show significantly higher rates of smoker identification, physician intervention and follow-up for smoking, and use of quit-smoking medications.

A.3. To investigate the effects of the EDIS enhancement on relevant behavioral and psychological constructs that may act as mediators of smoking behavior change ("Mechanisms of Action"), and the relationships of these potential mediators to smoking cessation (e.g., perceived risk, nicotine dependence; in Measures section). H3) Participants enrolled during Step 2 at RIH will show greater changes in posited mediational constructs than those enrolled in Step 1 and at the control site.

A.4. To examine the incremental costs of implementation of the intervention and to conduct analyses of marginal cost effectiveness using cost-per-smoker-quit. (This aim is not hypothesis driven) Exploratory Aim: A.5. To examine ED physician and other health care providers (HCP) attitudes regarding the utility of the EDIS system for tobacco intervention. The investigators will conduct interviews with ED physicians and nurses to elicit their perceptions of the usefulness and helpfulness of the modified EDIS, and its effects on their perceived self-efficacy and motivation to provide tobacco intervention. The investigators will also solicit direct feedback on the modified platform and user interface.

Being tested
EDIS, Care as usual
Keywords
Smoking, Tobacco, Emergency Department
Medical subject headings
Tobacco Use Disorder, Smoking, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EDISOther

    Changes made to EDIS system to improve tracking and treatment of smoking in the ED

  • Care as usualOther

    Care as usual in the ED will be tracked

Study groups in NCT01839903
Study groupRoleWhat they receive
RIH EDISActive comparatorData will be collected in two steps at the RIH site: step one will be care as usual. Step 2 will involve changes to the EDIS system
Receives: Other: EDIS; Other: Care as usual
Care as usualActive comparatorCare as usual in the ED will be tracked
Receives: Other: Care as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking abstinence

    Smoking abstinence at 6 month follow up. Abstinence is determined by Cotinine validated 7-day point prevalence abstinence at each follow up (24 hour, 3 month, 6, month)

    Measured: 6 month

Secondary outcomes (1)
  1. Changes in health care provider intervention

    Data will be collected on rates of smoker identification and intervention by ED health care personnel during the first phase and second phase (12 months each) of this study

    Measured: Basline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study start19 Aug 2011
  3. Primary completion30 Jun 2016
  4. Study completion30 Jun 2017

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839903
Sponsor's protocol ID
1R01CA156699
Acronym
STTEPS
Status last verified
Mar 2019
First submitted
22 Apr 2013
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing EDIS and Care as usual in people with Tobacco Dependence, run by The Miriam Hospital at 2 sites 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 6 inclusion and 2 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Smoking abstinence (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Apr 2019.

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