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A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults

A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01972308
Acronym
HAP2
Enrollment
312
Registered
2013-10-30
Start date
2013-12-12
Completion date
2022-04-30
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Communication

Keywords

asthma, patient advocate, health disparity, patient-provider communication

Brief summary

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.

Detailed description

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

Interventions

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.

BEHAVIORALUsual Care

Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. \> 18 years of age, 2. physician's diagnosis of asthma, 3. prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician), 4. moderate or severe persistent asthma according to the NHLBI Guidelines, 5. evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) \< 80% predicted at the time of screening or within the 3 years prior to this screening, and (b) improvement with bronchodilator: either (i) an increase of \>15% and 200ml in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC \>12% and 200 ml in FEV1 within 30 minutes, 6. at least one appointment scheduled with the asthma physician during the 1st 6 months of participation

Exclusion criteria

1. Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities. 2. Unable to understand and provide informed consent, 3. Unable to communicate in English or Spanish. 4. Participants of the pilot study for this project are excluded

Design outcomes

Primary

MeasureTime frameDescription
Change in Asthma Control at One Yearbaseline and 1 yearAsthma 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.

Secondary

MeasureTime frameDescription
Change in Emergency Department(ED) Visits at One Yearone yearEmergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint
Change in Asthma-related Quality of Lifebaseline to one yearAsthma-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.
Change in Hospitalizationsone yearParticipants 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.
Risk of Prednisone Burstsbaseline and one yeara new dose or an increase in already prescribed prednisone dose
Change in Urgent Office Visitone yearRecords 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Patient Advocate
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. Patient Advocate: 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
156
Usual Care
Patient receives asthma care as usual from their asthma provider
156
Total312

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath41
Overall StudyLost to Follow-up46
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicPatient AdvocateUsual CareTotal
Age, Continuous52.6 years
STANDARD_DEVIATION 14.3
49.6 years
STANDARD_DEVIATION 13.7
51.1 years
STANDARD_DEVIATION 14
asthma control questionnaire2.3 units on a scale
STANDARD_DEVIATION 1.1
2.4 units on a scale
STANDARD_DEVIATION 1.2
2.4 units on a scale
STANDARD_DEVIATION 1.2
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants11 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
142 Participants145 Participants287 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
100 Participants106 Participants206 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants12 Participants26 Participants
Race (NIH/OMB)
White
40 Participants35 Participants75 Participants
Sex: Female, Male
Female
101 Participants115 Participants216 Participants
Sex: Female, Male
Male
55 Participants41 Participants96 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 1561 / 156
other
Total, other adverse events
71 / 15674 / 156
serious
Total, serious adverse events
89 / 15690 / 156

Outcome results

Primary

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

Population: 18 years or more, physician's diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateChange in Asthma Control at One Year-0.42 units on a scale
Usual CareChange in Asthma Control at One Year-0.11 units on a scale
95% CI: [-0.64, 0.04]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateChange in Asthma-related Quality of Life0.28 units on a scale
Usual CareChange in Asthma-related Quality of Life0.23 units on a scale
95% CI: [-0.33, 0.43]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateChange in Emergency Department(ED) Visits at One Year-0.90 visits per 6 months
Usual CareChange in Emergency Department(ED) Visits at One Year-0.24 visits per 6 months
95% CI: [-1.38, -0.01]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateChange in Hospitalizations-0.30 hospitalizations per 6 months
Usual CareChange in Hospitalizations-0.36 hospitalizations per 6 months
95% CI: [-0.42, 0.48]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateChange in Urgent Office Visit-0.24 urgent visits per 6 months
Usual CareChange in Urgent Office Visit-0.42 urgent visits per 6 months
95% CI: [-0.24, 0.6]
Secondary

Risk of Prednisone Bursts

a new dose or an increase in already prescribed prednisone dose

Time frame: baseline and one year

ArmMeasureValue (LEAST_SQUARES_MEAN)
Patient AdvocateRisk of Prednisone Bursts-0.005 risk of prednisone bursts
Usual CareRisk of Prednisone Bursts-0.05 risk of prednisone bursts
95% CI: [-0.1, 0.19]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026