Feasibility of the BREATHE Asthma Intervention Trial
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Healthy Studies |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2017 |
| Start Date: | April 4, 2017 |
| End Date: | September 22, 2017 |
Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial
Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured
adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn
may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A
brief shared decision-making intervention for use by primary care providers in Federally
Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve
asthma control in this high-risk patient group.
adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn
may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A
brief shared decision-making intervention for use by primary care providers in Federally
Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve
asthma control in this high-risk patient group.
Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled
corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in
poor and minority populations. Non-adherence to ICS is associated with erroneous personal
health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this,
no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared
decision-making interventions have not been tested in underserved Black adults, despite this
model's success in pediatric populations and in White, privately insured patients with
asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients
achieve asthma control but are overlooked in asthma intervention research. Process
evaluations are often lacking during intervention development. We will address these
treatment and methodological gaps.
Objectives: This pilot study will (1) develop a brief shared decision-making intervention
delivered by primary care providers (PCPs) to improve asthma control in Black adults
receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and
(3) assess preliminary evidence of intervention effects on asthma control, ICS adherence,
forced expiratory volume in one second (FEV1) - an objective lung function measure - and
asthma quality of life (QOL) over a 3-month follow-up period.
Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months,
relative to controls, patients whose PCPs are trained in the intervention will have
significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma
QOL (secondary outcomes).
Methods: Using community-based participatory research and including a Patient Advocate, we
will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention
development is guided by patient and family/support persons of asthma patients input, as well
as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from
2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with
uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs
will be randomized within FQHC to intervention and control; patients will be followed for 3
months. Process evaluation interviews with patients and PCPs will obtain feedback regarding
intervention procedures.
Significance: This study has high public health significance because it (1) targets a highly
vulnerable population for poor asthma control - Black poor adults with erroneous asthma care
beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a
novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and
negative ICS beliefs, and which has the potential to amplify intervention effects and
increase the likelihood of sustainability; and (3) includes a process evaluation, bridging
the gap between science and practice, and aiding in the design of a full-scale randomized
controlled trial (RCT).
corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in
poor and minority populations. Non-adherence to ICS is associated with erroneous personal
health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this,
no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared
decision-making interventions have not been tested in underserved Black adults, despite this
model's success in pediatric populations and in White, privately insured patients with
asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients
achieve asthma control but are overlooked in asthma intervention research. Process
evaluations are often lacking during intervention development. We will address these
treatment and methodological gaps.
Objectives: This pilot study will (1) develop a brief shared decision-making intervention
delivered by primary care providers (PCPs) to improve asthma control in Black adults
receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and
(3) assess preliminary evidence of intervention effects on asthma control, ICS adherence,
forced expiratory volume in one second (FEV1) - an objective lung function measure - and
asthma quality of life (QOL) over a 3-month follow-up period.
Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months,
relative to controls, patients whose PCPs are trained in the intervention will have
significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma
QOL (secondary outcomes).
Methods: Using community-based participatory research and including a Patient Advocate, we
will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention
development is guided by patient and family/support persons of asthma patients input, as well
as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from
2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with
uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs
will be randomized within FQHC to intervention and control; patients will be followed for 3
months. Process evaluation interviews with patients and PCPs will obtain feedback regarding
intervention procedures.
Significance: This study has high public health significance because it (1) targets a highly
vulnerable population for poor asthma control - Black poor adults with erroneous asthma care
beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a
novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and
negative ICS beliefs, and which has the potential to amplify intervention effects and
increase the likelihood of sustainability; and (3) includes a process evaluation, bridging
the gap between science and practice, and aiding in the design of a full-scale randomized
controlled trial (RCT).
The intervention trial will be informed by focus groups
Focus Group Inclusion Criteria:
- Adult patients with persistent asthma or loved ones of adult patients with persistent
asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at
the participating FQHCs
Focus Group Exclusion Criteria:
- Patients with persistent asthma or loved ones of patients with persistent asthma under
they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs
Intervention Inclusion Criteria:
Patients must be:
1. Adults (18 years of age or older)
2. PCP-diagnosed persistent asthma
3. Currently prescribed ICS
4. Receiving asthma care at participating FQHCs
5. Who screen positive for uncontrolled asthma
6. Have erroneous personal health and/or negative ICS beliefs
Intervention Exclusion Criteria:
1. Participation in focus groups during the development phase
2. Non-English speaking
3. Serious mental health conditions (e.g., psychosis) that preclude completion of study
procedures or confound analyses
We found this trial at
2
sites
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