AzTrials
AzTrials

SmokingNCT00273806

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

A study testing Intervention for 4 behavioral risks by medical assistants. in people with Smoking and Problem Drinking, run by The University of Texas Health Science Center at San Antonio at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking, Problem Drinking, Sedentary Lifestyle
What is being tested?
Intervention for 4 behavioral risks by medical assistants.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
864 participants
Where
6 sitesUnited States
Study dates
Dec 2005to May 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Unwillingness to participate

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • University Center for Community Health

    San Antonio, Texas, 78207

  • University Health Center Downtown

    San Antonio, Texas, 78207

  • University Health Center North

    San Antonio, Texas, 78216

  • University Health Center Southeast

    San Antonio, Texas, 78223

  • University Physicians Group - Diagnostic Pavilion

    San Antonio, Texas, 78229

  • University Health Center Southwest

    San Antonio, Texas, 78237

Other trials in United States

About this study

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.

Read the 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.

Being tested
Intervention for 4 behavioral risks by medical assistants.
Keywords
Behavioral risk factors, Primary Care, Health services research
Medical subject headings
Smoking, Alcoholism, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention for 4 behavioral risks by medical assistants.Behavioural

Study groups in NCT00273806
Study groupRoleWhat they receive
1ExperimentalMedical assistant identification and referral for behavioral risk factors.
Receives: Behavioral: Intervention for 4 behavioral risks by medical assistants.
2No interventionUsual care for behavioral risk factors.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).

Secondary outcomes (6)
  1. Total number of health risks identified and interventions ordered by medical assistants (measure program impact).

  2. Rate of behavioral risks identified by MA's (risks identified/patients assessed).

  3. Rate of interventions ordered by MA's (interventions ordered/patients assessed).

  4. Time-motion impact of intervention on medical assistants.

  5. Impact on MA satisfaction (qualitative interviews).

  6. Cost of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
864 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273806
Sponsor's protocol ID
053766
Status last verified
Aug 2008
First submitted
4 Jan 2006
Last updated
27 Aug 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention for 4 behavioral risks by medical assistants. in people with Smoking and Problem Drinking, run by The University of Texas Health Science Center at San Antonio at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in