- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510341
Evaluating the Collaborative Management in Pediatrics (CMP) Training Program Among Pediatric Resident Doctors and Their Patients With Asthma or Obesity (CMP)
Asthma Management Support Training in Pediatrics
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98122
- Odessa Brown Children's Clinic
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Seattle, Washington, United States, 98104
- Harborview's Children and Teens Clinic
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Seattle, Washington, United States, 98105
- Pediatric Care Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Pediatric Resident Doctors:
- 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)
Inclusion Criteria for Child Participants:
- Diagnosed with either asthma or obesity and on the continuity panel of a participating resident doctor
Exclusion Criteria for Pediatric Resident Doctors:
- Previously participated in the project development of the CMP training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 2
Control group
|
|
ACTIVE_COMPARATOR: 1
CMP program
|
Pediatric residents will receive two 4.5 hour training sessions on the CMP Program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility and acceptability of various components of the CMP program
Time Frame: Measured at the completion of the 1-year study
|
Measured at the completion of the 1-year study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect size of CMP training on resident skills and patient-centered outcomes
Time Frame: Measured at the completion of the 1-year study
|
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
|
Measured at the completion of the 1-year study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paula Lozano, MD, MPH, Child Heatlh Institute, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 405
- R21HL080067-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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