A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults (HAP2)
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| ClinicalTrials.gov Identifier: NCT01972308 |
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Recruitment Status :
Active, not recruiting
First Posted : October 30, 2013
Results First Posted : August 6, 2018
Last Update Posted : July 15, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma Communication | Behavioral: Patient Advocate Behavioral: Usual Care | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 312 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Health Services Research |
| Official Title: | A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults |
| Actual Study Start Date : | December 12, 2013 |
| Actual Primary Completion Date : | March 16, 2017 |
| Estimated Study Completion Date : | May 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: 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 accomplishing medical advice, and transfer of information between provider and patient. |
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usual care
Patient receives asthma care as usual from their asthma provider
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Behavioral: Usual Care
Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines |
- Change in Asthma Control at One Year [ Time Frame: baseline and 1 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.
- Change in Emergency Department(ED) Visits at One Year [ Time Frame: 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
- Change in Asthma-related Quality of Life [ Time Frame: baseline to one year ]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.
- Change in Hospitalizations [ Time Frame: one year ]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.
- Risk of Prednisone Bursts [ Time Frame: baseline and one year ]a new dose or an increase in already prescribed prednisone dose
- Change in Urgent Office Visit [ Time Frame: one year ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age,
- physician's diagnosis of asthma,
- prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),
- moderate or severe persistent asthma according to the NHLBI Guidelines,
- 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,
- at least one appointment scheduled with the asthma physician during the 1st 6 months of participation
Exclusion Criteria:
- Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.
- Unable to understand and provide informed consent,
- Unable to communicate in English or Spanish.
- Participants of the pilot study for this project are excluded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972308
| United States, Pennsylvania | |
| University of Pennsylvania Health System | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Andrea J Apter, MD | University of Pennsylvania |
Documents provided by Andrea Apter, University of Pennsylvania:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrea Apter, Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01972308 |
| Other Study ID Numbers: |
1R18HL116285-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 30, 2013 Key Record Dates |
| Results First Posted: | August 6, 2018 |
| Last Update Posted: | July 15, 2021 |
| Last Verified: | July 2021 |
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asthma patient advocate health disparity patient-provider communication |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |