An interventional study of Patient Advocate and Usual Care in Asthma and Communication, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.
This 5 year project tests the effectiveness, sustainability, and budget impact of a patient navigator intervention to facilitate and maintain patient-provider communication and access to chronic care of moderate or severe asthma in low income minority adults with other chronic morbidities. We will recruit from a variety of clinic practices including those of an urban academic health center, a VA, and a federally qualified health center and in both English-speaking and Spanish-speaking patients. The intervention is tailored to patients and their clinics, and informed by focus groups of patients and providers.
The Patient Advocate (PA), works with patients by coaching and modeling preparation for a visit with the asthma doctor, attending the visit with the permission of participant and provider, and confirming understanding of issues discussed. The PA also facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and exchange of information between providers and patients. The PAs are recent college graduates interested in health-related or education careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential subjects.
This dissemination and implementation project refines the intervention of RC1 HL099612 for real-world practice by 1) conducting a randomized controlled trial that compares the Patient Advocate Intervention (PAI) to currently practiced guideline-based usual care; 2) carrying out the intervention in a variety of primary care and asthma specialty practices; 3) extending the observation time to a year to test its sustainability; 4) assessing patient-centered outcomes including asthma control, quality of life, ED visits, and hospitalizations; 5) assessing mediators/moderators of the PAI-asthma outcome relationship; and 6) evaluating its cost-effectiveness.
We will recruit 300 adults, each to be followed for at least 1 year with moderate or severe persistent asthma from clinics serving low-income, urban, primarily minority patients and conduct a randomized controlled trial (RCT) to: 1) assess whether 6 months of the PAI improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion, 2) Assess whether the PAI improves other asthma outcomes (need for prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline compared with UC at 6 months and is sustained in the 6 months following the intervention's completion, 3) examine mediators and moderators of the relationship between the intervention and outcome, 4) assess the incremental direct and indirect costs of the PAI compared to usual care and the cost-effectiveness of the PAI relative to UC for the outcomes, and 5) in post-study focus groups of providers to explore awareness of the intervention and response to the PA
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 312 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Behavioral: Patient Advocate
Patient receives asthma care as usual from their asthma provider
Behavioral: Usual Care
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient.
Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines
Change in Asthma Control at One Year
Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \> 1.5 is considered inadequate control.
Time frame: baseline and 1 year
Change in Emergency Department(ED) Visits at One Year
Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint
Time frame: one year
Change in Asthma-related Quality of Life
Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.
Time frame: baseline to one year
Change in Hospitalizations
Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.
Time frame: one year
Risk of Prednisone Bursts
a new dose or an increase in already prescribed prednisone dose
Time frame: baseline and one year
Change in Urgent Office Visit
Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.
Time frame: one year
| Milestone | Patient Advocate | Usual Care |
|---|---|---|
| Started | 156 | 156 |
| Completed | 148 | 148 |
| Not completed | 8 | 8 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 4 | 6 |
| Withdrew: Death | 4 | 1 |
Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \> 1.5 is considered inadequate control.
| units on a scale | Patient Advocate | Usual Care |
|---|---|---|
| Change in Asthma Control at One Year | -0.42 (-0.65 to -0.18) | -0.11 (-0.37 to 0.12) |
Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint
| visits per 6 months | Patient Advocate | Usual Care |
|---|---|---|
| Change in Emergency Department(ED) Visits at One Year | -0.90 (-1.50 to -0.42) | -0.24 (-0.60 to 0.18) |
Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.
| units on a scale | Patient Advocate | Usual Care |
|---|---|---|
| Change in Asthma-related Quality of Life | 0.28 (0.01 to 0.54) | 0.23 (-0.05 to 0.48) |
Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.
| hospitalizations per 6 months | Patient Advocate | Usual Care |
|---|---|---|
| Change in Hospitalizations | -0.30 (-0.66 to -0.06) | -0.36 (-0.66 to -0.12) |
a new dose or an increase in already prescribed prednisone dose
| risk of prednisone bursts | Patient Advocate | Usual Care |
|---|---|---|
| Risk of Prednisone Bursts | -0.005 (-0.10 to 0.10) | -0.05 (-0.14 to 0.05) |
Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.
| urgent visits per 6 months | Patient Advocate | Usual Care |
|---|---|---|
| Change in Urgent Office Visit | -0.24 (-0.54 to 0.02) | -0.42 (-0.72 to -0.12) |
Collected over one year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Advocate | 4/156 (2.6%) | 89/156 (57.1%) | 71/156 (45.5%) |
| Usual Care | 1/156 (0.6%) | 90/156 (57.7%) | 74/156 (47.4%) |
| Event | Patient Advocate | Usual Care |
|---|---|---|
| BronchospasmRespiratory, thoracic and mediastinal disorders | 43/156 | 44/156 |
| surgical and medical procedureSurgical and medical procedures | 14/156 | 7/156 |
| back painMusculoskeletal and connective tissue disorders | 4/156 | 9/156 |
| abdominal painGastrointestinal disorders | 6/156 | 7/156 |
| short of breathRespiratory, thoracic and mediastinal disorders | 6/156 | 3/156 |
| chest painCardiac disorders | 6/156 | 6/156 |
| foot painMusculoskeletal and connective tissue disorders | 5/156 | 2/156 |
| fallInjury, poisoning and procedural complications | 3/156 | 5/156 |
| ankle sprainInjury, poisoning and procedural complications | 3/156 | 5/156 |
| headacheNervous system disorders | 2/156 | 5/156 |
| Event | Patient Advocate | Usual Care |
|---|---|---|
| BronchospasmRespiratory, thoracic and mediastinal disorders | 29/156 | 31/156 |
| foot painGeneral disorders | 8/156 | 4/156 |
| short of breathRespiratory, thoracic and mediastinal disorders | 7/156 | 6/156 |
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 6/156 | 2/156 |
| skin disordersSkin and subcutaneous tissue disorders | 6/156 | 1/156 |
| headacheNervous system disorders | 2/156 | 5/156 |
| depressionPsychiatric disorders | 4/156 | 4/156 |
| sinusitisInfections and infestations | 4/156 | 3/156 |
| surgical and medical proceduresSurgical and medical procedures | 3/156 | 3/156 |
| abdominal painGastrointestinal disorders | 2/156 | 3/156 |
| Age, Continuous(years) | Patient Advocate | Usual Care | Total |
|---|---|---|---|
| Mean | 52.6 ± 14.3 | 49.6 ± 13.7 | 51.1 ± 14.0 |
| Sex: Female, Male(Participants) | Patient Advocate | Usual Care | Total |
|---|---|---|---|
| Female | 101 | 115 | 216 |
| Male | 55 | 41 | 96 |
| Ethnicity (NIH/OMB)(Participants) | Patient Advocate | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 11 | 25 |
| Not Hispanic or Latino | 142 | 145 | 287 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patient Advocate | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 100 | 106 | 206 |
| White | 40 | 35 | 75 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 14 | 12 | 26 |
| asthma control questionnaire(units on a scale) | Patient Advocate | Usual Care | Total |
|---|---|---|---|
| Mean | 2.3 ± 1.1 | 2.4 ± 1.2 | 2.4 ± 1.2 |
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