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

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00273806
First received: January 4, 2006
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Smoking
Problem Drinking
Sedentary Lifestyle
Unhealthy Diet
Behavioral: Intervention for 4 behavioral risks by medical assistants.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Engaging the Team: A Multilevel Program to Promote Healthy Behaviors

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).

Secondary Outcome Measures:
  • Total number of health risks identified and interventions ordered by medical assistants (measure program impact).
  • Rate of behavioral risks identified by MA's (risks identified/patients assessed).
  • Rate of interventions ordered by MA's (interventions ordered/patients assessed).
  • Time-motion impact of intervention on medical assistants.
  • Impact on MA satisfaction (qualitative interviews).
  • Cost of intervention.

Enrollment: 864
Study Start Date: December 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Medical assistant identification and referral for behavioral risk factors.
Behavioral: Intervention for 4 behavioral risks by medical assistants.
No Intervention: 2
Usual care for behavioral risk factors.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273806

Locations
United States, Texas
University Health Center Downtown
San Antonio, Texas, United States, 78207
University Health Center Southeast
San Antonio, Texas, United States, 78223
University Health Center Southwest
San Antonio, Texas, United States, 78237
University Health Center North
San Antonio, Texas, United States, 78216
University Center for Community Health
San Antonio, Texas, United States, 78207
University Physicians Group - Diagnostic Pavilion
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Robert L Ferrer, MD, MPH The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00273806     History of Changes
Other Study ID Numbers: 053766
Study First Received: January 4, 2006
Last Updated: August 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Behavioral risk factors
Primary Care
Health services research

Additional relevant MeSH terms:
Smoking
Alcoholism
Habits
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014