Smoking Clinical Trial
Official title:
Engaging the Team: A Multilevel Program to Promote Healthy Behaviors
The purpose of the study is to determine whether a program of screening and intervention for four health risk behaviors (smoking, problem drinking, sedentary lifestyle, unhealthy diet) carried out by medical assistants in primary care practices can help patients improve their behaviors. The hypothesis is that patients who receive the intervention will demonstrate higher rates of health behavior change than patients who receive usual care.
Unhealthy behaviors are the most common actual causes of death in the United States. The
high prevalence of behavioral risk factors in primary care calls for a response of
appropriate scale. One strategy to achieve a greater scale of delivering interventions is to
relieve the bottleneck of physician assessment and management. Creating a system that
engages other members of the primary care team to link patients who are ready to change with
practice, health system and community resources is a mechanism to amplify the practice's
impact and thus achieve the necessary scale.
The project evaluates a model of primary care that manages population risk with appropriate
expertise at the necessary scale. We test the effectiveness of a medical assistant-based
program to link patients with behavioral risk factors to interventions at the practice,
health system, and community levels. We hypothesize that intervention-group patients will
achieve higher rates of behavior change than control patients.
The study is a controlled trial in the PRENSA network, which includes six urban practices
serving a disadvantaged Latino population. Using data from a health risk assessment (HRA)
routinely collected in PRENSA practices, medical assistants will assess 4500 patients'
behavioral risks and apply behavior-specific "assess-advise-agree-assist-arrange" algorithms
to engage behavioral interventions in the practices, health system, and local public health
department. Outcomes data will be collected at 6-9 month follow-up with repeated completion
of a standardized health risk assessment. The primary analyses will compare outcome measures
for smoking, problem drinking, sedentary lifestyle, and unhealthy diet in intervention and
control patients.
We anticipate the study will show a medical assistant-based program to address smoking,
risky drinking, sedentary living, and unhealthy diet in primary care to be feasible and
effective. We will evaluate program effectiveness by assessing the number of patients
reached, interventions requested and completed, impact on medical assistant workflow and
satisfaction, costs to the practices, and impact on health behaviors.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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