Tobacco Use DisorderPhase 1NCT00269009
CHERL, Connecting Primary Care Patients With Community Resources to Facilitate Behavior Change
A Phase 1 study testing CHERL in people with Tobacco Use Disorder and Alcohol Abuse, run by Great Lakes Research Into Practice Network at 3 sites in United States.
Trial summary
The investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Alcohol Abuse, Lack of Physical Activity
- What is being tested?
- CHERL
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Feb 2007
- Phase
- Phase 1
- 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
- Patients, clinicians, and their staff participating in this GRIN study.
Who cannot join
- Patients, clinicians, and their staff who are not participating in this GRIN study.
Trial locations and contacts
3 sites in 1 country.
Jodi Holtrop contact
United States3 sites, 3 recruiting
- Recruiting
Genesys Health System
Flint, Michigan, 48446
Amy Thompson, 810-245-4523
- Recruiting
MCRC
Grand Rapids, Michigan, 48823
Lori Fitzpartick, 616-732-6213
- Recruiting
UP Health Education Corporation
Marquette, Michigan, 49855
Debra Weymouth, 906-225-7667
About this study
The investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.
Read the detailed description
What is this about? Prescription for Health (P4H) is a national initiative funded by the Robert Wood Johnson Foundation. Nine projects have been funded nationally in this second round to advance the goals of improving health behavior identification and delivery in primary care practice. Each project is conducted through a practice-based research network (PBRN). In Michigan, our PBRN is called the Great Lakes Research In Practice Network (GRIN).
What is the purpose of the CHERL project? In our study, we want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.
Primary care providers play a key roll in encouraging patients to choose healthy behaviors. However, effective behavior change requires long term follow up and support that may not be readily available within the office practice. CHERL can help provide or link to those services thus helping the healthy message promoted by the clinician to have a more powerful and lasting effect.
What is the CHERL intervention? With this funding, we will hire and train a CHERL to work with practices. The purpose of the CHERL is for him/her to help secure behavior change support for your patients either by referring to an available resource within the community or directly providing the service. This service is available to patients with or without chronic disease diagnoses (i.e, patients with diabetes, heart disease, hypertension, obesity, back pain, lung disease, or generally healthy with opportunities to change unhealthy habits).
Patients are referred to the CHERL and he/she will determine an appropriate next step for your patient - either referral to a community program or the CHERL will provide brief telephone counseling. The health care provider will receive feedback specifically on each patient referred.
In addition, some practices (consultant-enhanced) will receive additional assistance from the CHERL, as he/she serves as a consultant to the practice, helping the practice to identify systematic mechanisms for identification and referral of at risk patients to the CHERL.
- Being tested
- CHERL
- Keywords
- Tobacco use
- Medical subject headings
- Tobacco Use Disorder, Alcoholism, Sedentary Behavior, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHERLBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest is the referral rate for any unhealthy behavior to the CHERL with the predictor variable being referral-only versus consultant-enhanced practices.
Secondary outcomes (1)
Aim 2 of the study is to determine if the patients referred to the CHERL demonstrate health behavior improvements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJan 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Great Lakes Research Into Practice Network
- Sponsor type
- Research network
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ), Michigan Department of Community Health, Marquette General Health System, Upper Peninsula Health Education Corporation;, Grand Rapids Medical Education and Research Center for Health Professions, Greater Flint Health Coalition, Genesee Health Plan, Genesys Health System
- Investigators
- Jodi Holtrop, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269009
- Sponsor's protocol ID
- 61-9165
- Status last verified
- Sep 2006
- First submitted
- 22 Dec 2005
- Last updated
- 11 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHERL, Connecting Primary Care Patients With Community Resources to Facilitate Behavior Change
- ClinicalTrials.gov ID
- NCT00269009
- Acronym / sponsor ID
- 61-9165
- Keywords
- Tobacco use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Great Lakes Research Into Practice NetworkResearch network
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ), Michigan Department of Community Health, Marquette General Health System, Upper Peninsula Health Education Corporation;, Grand Rapids Medical Education and Research Center for Health Professions, Greater Flint Health Coalition, Genesee Health Plan, Genesys Health System
- Study start
- Jan 2006
- Study completion
- Feb 2007
- First posted
- 23 Dec 2005 (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 investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.
Detailed description
What is this about? Prescription for Health (P4H) is a national initiative funded by the Robert Wood Johnson Foundation. Nine projects have been funded nationally in this second round to advance the goals of improving health behavior identification and delivery in primary care practice. Each project is conducted through a practice-based research network (PBRN). In Michigan, our PBRN is called the Great Lakes Research In Practice Network (GRIN).
What is the purpose of the CHERL project? In our study, we want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.
Primary care providers play a key roll in encouraging patients to choose healthy behaviors. However, effective behavior change requires long term follow up and support that may not be readily available within the office practice. CHERL can help provide or link to those services thus helping the healthy message promoted by the clinician to have a more powerful and lasting effect.
What is the CHERL intervention? With this funding, we will hire and train a CHERL to work with practices. The purpose of the CHERL is for him/her to help secure behavior change support for your patients either by referring to an available resource within the community or directly providing the service. This service is available to patients with or without chronic disease diagnoses (i.e, patients with diabetes, heart disease, hypertension, obesity, back pain, lung disease, or generally healthy with opportunities to change unhealthy habits).
Patients are referred to the CHERL and he/she will determine an appropriate next step for your patient - either referral to a community program or the CHERL will provide brief telephone counseling. The health care provider will receive feedback specifically on each patient referred.
In addition, some practices (consultant-enhanced) will receive additional assistance from the CHERL, as he/she serves as a consultant to the practice, helping the practice to identify systematic mechanisms for identification and referral of at risk patients to the CHERL.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, clinicians, and their staff participating in this GRIN study.
Key exclusion criteria (1 listed)
- Patients, clinicians, and their staff who are not participating in this GRIN study.
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 |
|---|---|---|
| CHERL | Behavioural | – |
Primary outcome
The primary outcome of interest is the referral rate for any unhealthy behavior to the CHERL with the predictor variable being referral-only versus consultant-enhanced practices.
1 secondary outcome
Aim 2 of the study is to determine if the patients referred to the CHERL demonstrate health behavior improvements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2007.
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
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.
Jodi Holtrop contact
Jodi Holtrop, PhD principal investigator
Michigan State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHERL in people with Tobacco Use Disorder and Alcohol Abuse, run by Great Lakes Research Into Practice Network at 3 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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annette M Sokolnicki (517/353-0772 ext. 421, annette.sokolnicki@hc.msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of interest is the referral rate for any unhealthy behavior to the CHERL with the predictor variable being referral-only versus consultant-enhanced practices.. 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 11 Jan 2007.