Asthma
Conditions
Keywords
Asthma, Child, Problem-solving, Quality of Life, Barriers to Care
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 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.
Interventions
BEHAVIORALProblem solving skills training
See description in Results
BEHAVIORALAsthma care coordination
See description in Results
OTHERUsual Care
Usual clinical care
Sponsors
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Counts of Patients With One or More Asthma-related Emergency Department Visits. | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) | 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). |
| Asthma Symptoms | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between June 11, 2004 and January 15, 2007. The final T3 follow up was completed on October 16, 2007.
Participants by arm
| Arm | Count |
|---|---|
| Care Coordination The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan). | 81 |
| Care Coordination+Problem Solving The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory. | 84 |
| Standard Care The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up. | 87 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 13 | 13 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 0 |
Baseline characteristics
| Characteristic | Care Coordination+Problem Solving | Standard Care | Care Coordination | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 84 Participants | 87 Participants | 81 Participants | 252 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7.37 years STANDARD_DEVIATION 3.1 | 7.26 years STANDARD_DEVIATION 3.02 | 7.47 years STANDARD_DEVIATION 3.13 | 7.37 years STANDARD_DEVIATION 3.07 |
| Region of Enrollment United States | 84 participants | 87 participants | 81 participants | 252 participants |
| Sex: Female, Male Female | 39 Participants | 34 Participants | 25 Participants | 98 Participants |
| Sex: Female, Male Male | 45 Participants | 53 Participants | 56 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 84 | 0 / 87 |
| serious Total, serious adverse events | 0 / 81 | 0 / 84 | 0 / 87 |
Outcome results
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.
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Coordination | Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | 81.2 units on a scale | Standard Error 1.4 |
| Care Coordination+Problem Solving | Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | 85.4 units on a scale | Standard Error 1.5 |
| Standard Care | Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | 80.8 units on a scale | Standard Error 1.5 |
Comparison: The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.p-value: 0.0595% CI: [0.63, 7.4]Mixed Models Analysis
Comparison: The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.p-value: 0.0595% CI: [-0.21, 6.4]Mixed Models Analysis
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.
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care Coordination | Asthma Symptoms | 21 participants |
| Care Coordination+Problem Solving | Asthma Symptoms | 9 participants |
| Standard Care | Asthma Symptoms | 24 participants |
Comparison: Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.p-value: 0.01195% CI: [0.13, 0.82]Regression, Logistic
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).
Time frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care Coordination | Counts of Patients With One or More Asthma-related Emergency Department Visits. | 10 participants |
| Care Coordination+Problem Solving | Counts of Patients With One or More Asthma-related Emergency Department Visits. | 4 participants |
| Standard Care | Counts of Patients With One or More Asthma-related Emergency Department Visits. | 10 participants |
p-value: 0.2195% CI: [0.18, 1.38]Regression, Logistic
p-value: 0.8595% CI: [0.53, 2.83]Regression, Logistic