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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem solving + care coordination | Experimental | Problem solving skills training and asthma care coordination |
|
| Asthma care coordination | Experimental | Asthma care coordination |
|
| Wait-list control | Active Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem solving skills training | Behavioral | See description in Results |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | The PedsQLâ„¢ 4.0 Generic Core Scales Total Scale Score (PedsQLâ„¢), 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 PedsQLâ„¢ 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Seid, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, San Diego | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20061311 | Result | 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):1133-43. doi: 10.1093/jpepsy/jsp133. Epub 2010 Jan 8. | |
| 18977978 | Derived |
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Participants were recruited between June 11, 2004 and January 15, 2007. The final T3 follow up was completed on October 16, 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) | The PedsQLâ„¢ 4.0 Generic Core Scales Total Scale Score (PedsQLâ„¢), 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 PedsQLâ„¢ 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Substantial dropout, particularly from CC+PST, is a limitation. Our sample size was not large enough, nor was there sufficient variability in our secondary outcomes, to detect differences in health care utilization despite the odds ratios.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Seid | CCHMC | 5138030083 | michael.seid@cchmc.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Asthma care coordination | Behavioral | See description in Results |
|
| Usual Care | Other | Usual clinical care |
|
| 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) |
| Seid M. Barriers to care and primary care for vulnerable children with asthma. Pediatrics. 2008 Nov;122(5):994-1002. doi: 10.1542/peds.2007-3114. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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). |
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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). | All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. | Posted | Number | participants | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) |
|
|
|
|
| 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. | 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. | Posted | Number | participants | Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) |
|
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | 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. | 0 | 84 | 0 | 84 |
| EG002 | 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. | 0 | 87 | 0 | 87 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 0.85 |
adjustment for age, race/ethnicity, Spanish language and mother's education |
| Odds Ratio (OR) |
| 1.22 |
| 2-Sided |
| 95 |
| 0.53 |
| 2.83 |
| No |
| Superiority or Other |