A Medical Assistant-Based Program to Promote Healthy Behaviors in Primary Care

Smoking Clinical Trial

Official title:

Engaging the Team: A Multilevel Program to Promote Healthy Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273806
• Other study ID #: 053766
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: August 26, 2008
• Start date: December 2005
• Est. completion date: May 2007

Study information

• Verified date: August 2008
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or over

• Uninsured, enrolled in Bexar County CareLink program

• Has completed baseline Health Risk Assessment

Exclusion Criteria:

• Unwillingness to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Problem Drinking
• Sedentary Lifestyle
• Smoking
• Unhealthy Diet

Intervention

Behavioral:
• Intervention for 4 behavioral risks by medical assistants.

Locations

Country	Name	City	State
United States	University Center for Community Health	San Antonio	Texas
United States	University Health Center Downtown	San Antonio	Texas
United States	University Health Center North	San Antonio	Texas
United States	University Health Center Southeast	San Antonio	Texas
United States	University Health Center Southwest	San Antonio	Texas
United States	University Physicians Group - Diagnostic Pavilion	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Agency for Healthcare Research and Quality (AHRQ), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).
Secondary	Total number of health risks identified and interventions ordered by medical assistants (measure program impact).
Secondary	Rate of behavioral risks identified by MA's (risks identified/patients assessed).
Secondary	Rate of interventions ordered by MA's (interventions ordered/patients assessed).
Secondary	Time-motion impact of intervention on medical assistants.
Secondary	Impact on MA satisfaction (qualitative interviews).
Secondary	Cost of intervention.

External Links

•   Link to Robert Wood Johnson Foundation's Prescription for Health Program