Clinical trial NCT00273806: A Medical Assistant-Based Program to Promote Healthy Behaviors in Primary Care
Official title: Engaging the Team: A Multilevel Program to Promote Healthy Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Problem Drinking
Sedentary Lifestyle
Unhealthy Diet
Keywords: Behavioral risk factors
Primary Care
Health services research
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-01-09
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Uninsured, enrolled in Bexar County CareLink program
* Has completed baseline Health Risk Assessment

Exclusion Criteria:

* Unwillingness to participate

Primary outcomes:
measure: Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).
Secondary outcomes:
measure: Total number of health risks identified and interventions ordered by medical assistants (measure program impact).
measure: Rate of behavioral risks identified by MA's (risks identified/patients assessed).
measure: Rate of interventions ordered by MA's (interventions ordered/patients assessed).
measure: Time-motion impact of intervention on medical assistants.
measure: Impact on MA satisfaction (qualitative interviews).
measure: Cost of intervention.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Center for Community Health
state: Texas
city: San Antonio
country: United States
facility: University Health Center Downtown
state: Texas
city: San Antonio
country: United States
facility: University Health Center North
state: Texas
city: San Antonio
country: United States
facility: University Health Center Southeast
state: Texas
city: San Antonio
country: United States
facility: University Physicians Group - Diagnostic Pavilion
state: Texas
city: San Antonio
country: United States
facility: University Health Center Southwest
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Robert L Ferrer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: