EducationCMPNCT00510341
Evaluating the Collaborative Management in Pediatrics (CMP) Training Program Among Pediatric Resident Doctors and Their Patients With Asthma or Obesity
A study testing Collaborative Management in Pediatrics (CMP) Program in people with Education and Asthma, run by University of Washington at 3 sites in United States.
Trial summary
Self-care behaviors are decisions and actions that people can take to improve their health or cope with a health problem. It is important for people with long-term illnesses to develop and maintain effective self-care behaviors. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Collaborative Management in Pediatrics (CMP) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2006to Mar 2008
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attends the University of Washington's pediatric residency program and has a continuity clinic at one of the three participating sites (Odessa Brown Children's Clinic, Pediatric Care Center, or Harborview's Children and Teens Clinic)
- Diagnosed with either asthma or obesity and on the continuity panel of a participating resident doctor
Who cannot join
- Previously participated in the project development of the CMP training
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harborview's Children and Teens Clinic
Seattle, Washington, 98104
Pediatric Care Center
Seattle, Washington, 98105
Odessa Brown Children's Clinic
Seattle, Washington, 98122
About this study
Official title: Asthma Management Support Training in Pediatrics
Self-care behaviors are decisions and actions that people can take to improve their health or cope with a health problem. It is important for people with long-term illnesses to develop and maintain effective self-care behaviors. This study will evaluate the usefulness and practicality of the Collaborative Management in Pediatrics (CMP) program, which is a training program developed to encourage pediatric resident doctors to promote self-management of illness and behavior change among children with asthma or obesity and their families.
Read the detailed description
Collaborative management health care involves strengthening and supporting self-care among people with long-term illnesses while assuring that effective medical, preventive, and health maintenance treatments occur. In collaborative management, it is important for patients, family members, and health care providers to understand each other's roles and responsibilities as they work toward a shared goal of improving the patient's health. Examples of self-care behaviors include reading books or other materials about relevant health care topics, exercising, following a low-fat diet, seeing a doctor on a regular basis, and making lifestyle changes. It is crucial that doctors, case managers, nurses, pharmacists, and other medical professionals understand the challenges that patients face when attempting to incorporate these self-care behaviors into their lives. Currently, there are few collaborative management programs that specifically address pediatric long-term illness and even fewer programs that identify doctors as the primary medical professional responsible for encouraging behavior change.
The CMP program will incorporate a collaborative management technique with a motivational interviewing approach. Motivational interviewing is a counseling style that attempts to increase awareness of the potential problems, causes, consequences experienced, and risks faced as a result of the behavior in question. The goal of the CMP program is to help pediatric resident doctors accomplish the following: assess patients' asthma and obesity status and related health behaviors; assess the child/family aspect of self-care; motivate parents and children to change asthma or obesity health behaviors; collaboratively set goals for asthma management by the family; and provide tailored follow-up to patients and their families. The purpose of this study is to evaluate the feasibility of the various components of the CMP program. Results from this study will be used to develop a larger clinical trial that will evaluate the effectiveness of the CMP program.
This pilot study will enroll 18 first-year pediatric resident doctors; each doctor will select five of their pediatric patients with asthma or obesity to participate in the study. Each resident doctor will be randomly assigned to take part in either the CMP program or a control group. All resident doctors will complete an Objective Structured Clinical Examination (OSCE), which will be used to assess their skills and ability in the areas of communication, clinical examination, medical procedures, prescribing medication, and interpretation of test results. Resident doctors participating in the CMP program will then receive CMP training. Three weeks following the initial OSCE, all resident doctors will perform a repeat OSCE, which will evaluate the effectiveness of the CMP training. One health care visit will then be conducted with each participating patient. During this visit, the resident doctor will conduct a collaborative management session emphasizing the family's central role in managing the child's health. Study researchers will conduct a 30-minute telephone interview with the child's parents at baseline, Week 6, following the heath care visit, and Month 3. Parent/child behaviors, attitudes related to asthma or obesity, management of their child's health, and satisfaction with care will be assessed during the telephone interviews. All residents will complete a repeat OSCE at Month 6 to assess any increase or decrease in skills.
- Being tested
- Collaborative Management in Pediatrics (CMP) Program
- Keywords
- Behavior Change Counseling, Motivational Interviewing, Chronic Care Model, Communication, Residency Training, Skill Assessment
- Medical subject headings
- Asthma, Obesity, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Management in Pediatrics (CMP) ProgramBehavioural
Pediatric residents will receive two 4.5 hour training sessions on the CMP Program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CMP program Receives: Behavioral: Collaborative Management in Pediatrics (CMP) Program |
| 2 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of various components of the CMP program
Measured: Measured at the completion of the 1-year study
Secondary outcomes (2)
Effect size of CMP training on resident skills and patient-centered outcomes
Measured: Measured at the completion of the 1-year study
Reliability of the OSCEs, which are used to assess resident skill
Measured: Measured at the completion of the 1-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startApr 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Paula Lozano, MD, MPH, Principal investigator, Child Heatlh Institute, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510341
- Sponsor's protocol ID
- 405
- Other IDs
- R21HL080067-01
- Acronym
- CMP
- Status last verified
- Dec 2012
- First submitted
- 31 Jul 2007
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lozano P, McPhillips HA, Hartzler B, Robertson AS, Runkle C, Scholz KA, Stout JW, Kieckhefer GM. Randomized trial of teaching brief motivational interviewing to pediatric trainees to promote healthy behaviors in families. Arch Pediatr Adolesc Med. 2010 Jun;164(6):561-6. doi: 10.1001/archpediatrics.2010.86.
PubMed 20530307
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Management Support Training in Pediatrics
- ClinicalTrials.gov ID
- NCT00510341
- Acronym / sponsor ID
- CMP / 405
- Keywords
- Behavior Change Counseling, Motivational Interviewing, Chronic Care Model, Communication, Residency Training, Skill Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Aug 2007 (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.
Self-care behaviors are decisions and actions that people can take to improve their health or cope with a health problem. It is important for people with long-term illnesses to develop and maintain effective self-care behaviors. This study will evaluate the usefulness and practicality of the Collaborative Management in Pediatrics (CMP) program, which is a training program developed to encourage pediatric resident doctors to promote self-management of illness and behavior change among children with asthma or obesity and their families.
Detailed description
Collaborative management health care involves strengthening and supporting self-care among people with long-term illnesses while assuring that effective medical, preventive, and health maintenance treatments occur. In collaborative management, it is important for patients, family members, and health care providers to understand each other's roles and responsibilities as they work toward a shared goal of improving the patient's health. Examples of self-care behaviors include reading books or other materials about relevant health care topics, exercising, following a low-fat diet, seeing a doctor on a regular basis, and making lifestyle changes. It is crucial that doctors, case managers, nurses, pharmacists, and other medical professionals understand the challenges that patients face when attempting to incorporate these self-care behaviors into their lives. Currently, there are few collaborative management programs that specifically address pediatric long-term illness and even fewer programs that identify doctors as the primary medical professional responsible for encouraging behavior change.
The CMP program will incorporate a collaborative management technique with a motivational interviewing approach. Motivational interviewing is a counseling style that attempts to increase awareness of the potential problems, causes, consequences experienced, and risks faced as a result of the behavior in question. The goal of the CMP program is to help pediatric resident doctors accomplish the following: assess patients' asthma and obesity status and related health behaviors; assess the child/family aspect of self-care; motivate parents and children to change asthma or obesity health behaviors; collaboratively set goals for asthma management by the family; and provide tailored follow-up to patients and their families. The purpose of this study is to evaluate the feasibility of the various components of the CMP program. Results from this study will be used to develop a larger clinical trial that will evaluate the effectiveness of the CMP program.
This pilot study will enroll 18 first-year pediatric resident doctors; each doctor will select five of their pediatric patients with asthma or obesity to participate in the study. Each resident doctor will be randomly assigned to take part in either the CMP program or a control group. All resident doctors will complete an Objective Structured Clinical Examination (OSCE), which will be used to assess their skills and ability in the areas of communication, clinical examination, medical procedures, prescribing medication, and interpretation of test results. Resident doctors participating in the CMP program will then receive CMP training. Three weeks following the initial OSCE, all resident doctors will perform a repeat OSCE, which will evaluate the effectiveness of the CMP training. One health care visit will then be conducted with each participating patient. During this visit, the resident doctor will conduct a collaborative management session emphasizing the family's central role in managing the child's health. Study researchers will conduct a 30-minute telephone interview with the child's parents at baseline, Week 6, following the heath care visit, and Month 3. Parent/child behaviors, attitudes related to asthma or obesity, management of their child's health, and satisfaction with care will be assessed during the telephone interviews. All residents will complete a repeat OSCE at Month 6 to assess any increase or decrease in skills.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Collaborative Management in Pediatrics (CMP) ProgramCMP program |
| 2 | No intervention | –Control group |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attends the University of Washington's pediatric residency program and has a continuity clinic at one of the three participating sites (Odessa Brown Children's Clinic, Pediatric Care Center, or Harborview's Children and Teens Clinic)
- Diagnosed with either asthma or obesity and on the continuity panel of a participating resident doctor
Key exclusion criteria (1 listed)
- Previously participated in the project development of the CMP training
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 |
|---|---|---|
| Collaborative Management in Pediatrics (CMP) ProgramPediatric residents will receive two 4.5 hour training sessions on the CMP Program. | Behavioural | 1 |
Primary outcome
Feasibility and acceptability of various components of the CMP program
Time frame: Measured at the completion of the 1-year study
2 secondary outcomes
Effect size of CMP training on resident skills and patient-centered outcomes
Time frame: Measured at the completion of the 1-year study
Reliability of the OSCEs, which are used to assess resident skill
Time frame: Measured at the completion of the 1-year study
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 20 Dec 2012.
- Derived from this study: PubMed 20530307Lozano P, McPhillips HA, Hartzler B, Robertson AS, Runkle C, Scholz KA, Stout JW, Kieckhefer GM. Randomized trial of teaching brief motivational interviewing to pediatric trainees to promote healthy behaviors in families. Arch Pediatr Adolesc Med. 2010 Jun;164(6):561-6. doi: 10.1001/archpediatrics.2010.86.
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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.
Paula Lozano, MD, MPH principal investigator
Child Heatlh Institute, University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Management in Pediatrics (CMP) Program in people with Education and Asthma, run by University of Washington 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 2 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 20 Dec 2012. 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.
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?
Feasibility and acceptability of various components of the CMP program (time frame: Measured at the completion of the 1-year study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510341, which also lists 1 linked publication.
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 20 Dec 2012.