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.
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.
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Smoking, Problem Drinking, Sedentary Lifestyle, Unhealthy Diet
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Medical assistant identification and referral for behavioral risk factors. Receives: Behavioral: Intervention for 4 behavioral risks by medical assistants. |
| 2 | No intervention | Usual care for behavioral risk factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).
Secondary outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Robert L Ferrer, MD, MPH, Principal investigator, The University of Texas Health Science Center at San Antonio
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging the Team: A Multilevel Program to Promote Healthy Behaviors
- ClinicalTrials.gov ID
- NCT00273806
- Acronym / sponsor ID
- 053766
- Conditions
- Smoking, Problem Drinking, Sedentary Lifestyle, Unhealthy Diet
- Keywords
- Behavioral risk factors, Primary Care, Health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Intervention for 4 behavioral risks by medical assistants.Medical assistant identification and referral for behavioral risk factors. |
| 2 | No intervention | –Usual care for behavioral risk factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over
- Uninsured, enrolled in Bexar County CareLink program
- Has completed baseline Health Risk Assessment
Key exclusion criteria (1 listed)
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for 4 behavioral risks by medical assistants. | Behavioural | 1 |
Primary outcome
Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.
- Link to Robert Wood Johnson Foundation's Prescription for Health ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Ferrer, MD, MPH principal investigator
The University of Texas Health Science Center at San Antonio
6 sites in 1 country: see every site and its status.
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.