Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02896400 |
| Other study ID # |
1603017332 |
| Secondary ID |
1R01CA201873-01A |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2017 |
| Est. completion date |
August 14, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators propose an innovative full-factorial design in a cohort of 1056 adult
smokers in an urban emergency department (ED), to test the efficacy of four key intervention
components: motivational interviewing, medication, quitline referral, and texting. At the
trial's completion, a mixed-methods approach will be used to identify the components that
were efficacious within the proposed cost constraint, along with feasibility and
acceptability to providers and subjects. The investigators will then assemble an intervention
that maximizes efficacy, given a cost-effectiveness constraint and findings from a
qualitative analysis.
Description:
The investigators propose to optimize the identification and treatment of adult smokers seen
in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to
develop a multicomponent intervention that will consist of some combination of the following:
(1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by
a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the
research participant, with application of the first patch in the ED (NRT); (3) active
referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a
short-messaging service (SMS) texting program for mobile phones (Text). Using MOST
principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify
the components most likely to be efficacious in combination. Although the factorial design
requires the allocation of participants to 16 different combinations of the 4 components
(Table 1), evaluation of each individual component is performed comparing all of those
receiving a component to all of those not receiving a component, making this an efficient
design. For instance, evaluation of the BNI component will compare those randomized to arms 1
through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a
2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention
package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test
the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated
Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and
SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed
constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified
components, delivered as a package, against a control arm in a new cohort of adult ED
smokers.
Our associated hypotheses are:
1. At 3 months, at least 1 intervention component will yield a biochemically verified
tobacco abstinence rate at least 5% greater than in the control condition. Carbon
monoxide breath test will be used for biochemical verification.
2. At 3 months, at least 1 intervention will be cost-effective, using a societal
perspective.
3. At 3 months, at least 1 intervention will be acceptable and feasible to providers and
subjects.
