Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250588
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2005-11-04
Brief Title:
Problem-Solving Skills Training to Improve Care for Children With Asthma
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
Reducing Barriers to Care for Vulnerable Children With Asthma
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Problem-Solving Skills Training is effective in reducing barriers to health care and improving health-related quality of life for children with persistent asthma
Detailed Description:
Brief description This 4-year research project will develop and test culturally and linguistically appropriate brief interventions to reduce barriers to health care for vulnerable children with persistent asthma
Background The US health system presents formidable challenges to the timely receipt of high quality care especially for vulnerable children eg those in families of color lower SES limited English ability This population is at greatest risk for poor health outcomes Children with asthma are an important vulnerable subgroup Asthma with an estimated prevalence of 69 is the most common chronic condition in children It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes
A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children connect the family with needed resources and coordinate care from different settings Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma Despite this evidence there is concern that the effects of care coordination may not be maintained once these services end This is particularly important given financial pressures to reduce the length and intensity of such services In order to maintain the gains achieved during care coordination families need to be able to identify and overcome barriers to care for and by themselves This can be achieved through the use of Problem Solving Therapy a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions
Study Goals The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma The specific aims of this two-phase project are
Phase I to adapt in collaboration with community health workers and parents existing materials to create two culturally and linguistically appropriate treatment manuals a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed step-by-step guide for implementing this approach to reduce barriers to care
Phase II to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy tPST in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma
Evidence for the efficacy of tPST and the availability of culturally and linguistically appropriate treatment manuals should spur diffusion of this innovation to other practitioners and programs seeking evidence-based optimal clinical management strategies
Methodology
Phase I Existing materials for the Care Coordination and tPST manuals will be edited andor rewritten to make them specific to asthma Then both the manuals and the proposed interventions will be assessed for cultural acceptability though two series of parallel focus groups one for parents of children with asthma and the other for home visitors already providing care coordination for families of children with asthma The revised educational materials will then be translated into Spanish
Phase II Children ages 2-12 years with persistent asthma and their families n 366 will be randomized into two brief interventions
1 tPST six sessions plus Care Coordination six home visits over 3 months versus a Wait List control group usual care to evaluate the interventions effectiveness in improving outcomes 3 months after baseline
2 tPST versus Care Coordination and Wait List to evaluate the interventions effectiveness in maintaining outcomes 9 months after baseline
Background The US health system presents formidable challenges to the timely receipt of high quality care especially for vulnerable children eg those in families of color lower SES limited English ability This population is at greatest risk for poor health outcomes Children with asthma are an important vulnerable subgroup Asthma with an estimated prevalence of 69 is the most common chronic condition in children It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes
A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children connect the family with needed resources and coordinate care from different settings Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma Despite this evidence there is concern that the effects of care coordination may not be maintained once these services end This is particularly important given financial pressures to reduce the length and intensity of such services In order to maintain the gains achieved during care coordination families need to be able to identify and overcome barriers to care for and by themselves This can be achieved through the use of Problem Solving Therapy a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions
Study Goals The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma The specific aims of this two-phase project are
Phase I to adapt in collaboration with community health workers and parents existing materials to create two culturally and linguistically appropriate treatment manuals a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed step-by-step guide for implementing this approach to reduce barriers to care
Phase II to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy tPST in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma
Evidence for the efficacy of tPST and the availability of culturally and linguistically appropriate treatment manuals should spur diffusion of this innovation to other practitioners and programs seeking evidence-based optimal clinical management strategies
Methodology
Phase I Existing materials for the Care Coordination and tPST manuals will be edited andor rewritten to make them specific to asthma Then both the manuals and the proposed interventions will be assessed for cultural acceptability though two series of parallel focus groups one for parents of children with asthma and the other for home visitors already providing care coordination for families of children with asthma The revised educational materials will then be translated into Spanish
Phase II Children ages 2-12 years with persistent asthma and their families n 366 will be randomized into two brief interventions
1 tPST six sessions plus Care Coordination six home visits over 3 months versus a Wait List control group usual care to evaluate the interventions effectiveness in improving outcomes 3 months after baseline
2 tPST versus Care Coordination and Wait List to evaluate the interventions effectiveness in maintaining outcomes 9 months after baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None