Problem-Solving Skills Training to Improve Care for Children With Asthma

Asthma Clinical Trial

Official title:

Reducing Barriers to Care for Vulnerable Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250588
• Other study ID #: R40 MC 00331
• Status: Completed
• Phase: N/A
• First received: November 4, 2005
• Last updated: April 25, 2013
• Start date: October 2003
• Est. completion date: October 2007

Study information

• Verified date: April 2013
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 U.S. health system presents formidable challenges to the timely receipt of high quality care, especially for vulnerable children (e.g., 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 6.9%, 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 and/or 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 intervention's effectiveness in improving outcomes 3 months after baseline.

2. tPST versus Care Coordination and Wait List to evaluate the intervention's effectiveness in maintaining outcomes 9 months after baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Child age 2 to 12 years old, inclusive

• Diagnosis of persistent asthma (mild, moderate, or severe) according to NHLBI criteria

• Family speaks English or Spanish

Exclusion Criteria:

• Family does not speak English or Spanish

• Child has other comorbid conditions that would affect care or outcomes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Problem solving skills training
See description in Results
• Asthma care coordination
See description in Results

Other:
• Usual Care
Usual clinical care

Locations

Country	Name	City	State
United States	Children's Hospital, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

References & Publications (1)

Seid M, Varni JW, Gidwani P, Gelhard LR, Slymen DJ. Problem-solving skills training for vulnerable families of children with persistent asthma: report of a randomized trial on health-related quality of life outcomes. J Pediatr Psychol. 2010 Nov;35(10):113 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)	The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.	Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)	No
Secondary	Counts of Patients With One or More Asthma-related Emergency Department Visits.	Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).	Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)	No
Secondary	Asthma Symptoms	Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.	Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)	No