Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00245323 |
| Other study ID # |
036798 |
| Secondary ID |
RWJF #036798RWJF |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2003 |
| Est. completion date |
August 2004 |
Study information
| Verified date |
October 2005 |
| Source |
Virginia Commonwealth University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine if checking smoking status as a routine vital sign
increases the delivery rate of cessation counseling to adult smokers in primary care
practices.
Description:
Two national clinical practice guidelines (CPGs) have advised primary care physicians to
implement an office-wide system for screening and recording tobacco-use status for every
patient at every office visit. These guidelines specifically recommended checking smoking
status as a vital sign. This tracking system is elegantly simple: As a prompt for the
physician, the nursing staff records the patient's response to a brief inquiry of their
smoking status (current, former, never) with the other vital sign data.
Scientific evidence that this measure increases physician counseling or smoking cessation is
limited. The proposed study evaluates the effectiveness of the vital sign intervention
through a practice-level randomized controlled trial.
18 practices will be recruited for the 9 month study. Eligible practices will include primary
care practices (family practice or internal medicine) with an average of two or more
full-time equivalent providers (including physician assistants and nurse practitioners), not
already using (or planning to institute during the study period) a practice-wide tobacco
identification and reminder system, and willing to participate in the study.
Data collection will occur in two phases; baseline and post intervention. The purpose of
baseline data collection is to provide a baseline counseling rate for each office prior to
randomization.
Over the course of both data collection periods, research assistants (RAs) will visit
individual practices on a rotating basis (about 16 visits per site on average). On average,
practices will be visited once a week during the baseline month and twice a month during the
intervention phase. The frequency of visits will be adjusted in an ongoing fashion by the PI,
as practices with a smaller number of providers, a lower prevalence of smokers, or a lower
survey participation rate will necessitate proportionally more visits to keep data collection
balanced at each site.
The RA will recruit patients following their interaction with the provider to participate in
a one page in-office survey. Upon returning the in-office survey, self-identified adult
current smokers who visited a physician that day will be recruited to participate in a 4 page
mail-back survey.
Both surveys are anonymous. A matching key code will be recorded on the returned in-office
survey for those patients given a mail-back survey to allow linked analysis, while
maintaining complete patient anonymity.
Following the baseline data collection, practices will be matched in clusters (by baseline
cessation counseling rate) and randomized within each cluster to intervention and control.
In the intervention practices, the research coordinator will work with the office manager to
implement the most appropriate method of recording the vital sign for that practice. To
facilitate timely implementation, the research coordinator will begin these discussions with
all the practices early in the study so that it can be implemented smoothly once the
randomization is determined. Depending on how the practice currently records routine vital
signs and documents visits in the chart, smoking as vital sign could be implemented with a
stamp on the visit note, modification to forms and/or progress note paper, or modification to
a vital sign flow sheet.
Immediately prior to implementation of the smoking vital sign in the 9 intervention
practices, the research coordinator will conduct an in-service training session with the
practices' nursing staff. For the six months intervention period in the intervention
practices, the nursing staff will record the patient's response to a brief inquiry of their
smoking status (current, former, never) with the other vital sign data. This information is
to be assessed routinely at each adult patient visit to the practice.
With the exception of nursing staff assessing and recording the smoking vital sign, all other
work of data collection will be done by VCU research staff. No intervention with providers
will be done.
During the six months intervention period and only in the intervention sites, the office or
nursing manager will be provided with periodic reports on how often patients' report having
been asked whether they smoke (a measure of implementation of the intervention) and asked to
share this with the nursing staff through the practice's usual QA/QI mechanisms to reinforce
continued performance of the intervention.
Taking into account the clustered design, statistical significance for the primary and
secondary hypotheses will be tested by hierarchical logistic regression using the SAS and
Sudaan statistical software. The mean rates for intervention practices will be compared to
the mean rates for control practices. Temporal trends for patient report of intervention
performance (having been asked their smoking status) and of the rates of cessation counseling
for intervention and control practices will be portrayed in time-series graphs. A
repeated-measures design will be incorporated into the categorical models to test the
statistical significance of temporal trends. Secondary data analysis will examine possible
influences of visit and smoking-related factors, provider, patient demographics, and health
status by adding these covariables to the categorical models.
Resolving scientific uncertainty about the vital sign's effectiveness is important. Tobacco
remains the leading cause of death and disability in this country. Few practices have adopted
the vital sign or any other type of tobacco tracking or reminder system. Evidence that this
intervention increases physician counseling with smokers would therefore argue for a change
in current practice patterns. If the vital sign intervention is not effective, then
expectations that practices adopt it (as recommended in the CPG) may be misguided.
Increasingly, primary care physicians are being encouraged to modify their practices to
incorporate quality-of-care interventions that lack scientific evidence of effectiveness.
Using randomized controlled trials to test the effectiveness of guidelines, including those
that are evidence-based, is necessary to insure that they are relevant and useful when
applied in typical primary care practices.
