Clinical trial NCT03695276: Pulmonary Specialist-Health Coach Consult Model Study
Official title: Pulmonary Specialist-Health Coach Consult (PuSHCon) Model to Improve Access to Specialist Consultation and Receipt of Recommended Evidence-based Care for Vulnerable Patients With Chronic Obstructive Pulmonary Disease (COPD) and Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD Asthma
Keywords: Health coaching
COPD
Asthma
Access to specialty care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, with randomization at the individual level
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Pulmonary Specialist-Health Coach Consultation (PuSHCon) study examines the implementation of health coach-assisted consultations to improve access to specialist care and implementation of specialist recommendations for patients with COPD, asthma, and asthma COPD overlap syndrome (ACOS) for low-income and vulnerable patients seen at public health clinics. Three hundred sixty (360) patients from ten clinics will be enrolled in the study and randomized at the individual level to receive health coaching or usual care; 180 patients will receive usual care and 180 patients will receive the PuSHCon model.

Detailed description: While evidence-based care for chronic obstructive pulmonary disease (COPD) and asthma can substantially reduce disease burden and prevent emergency visits and hospitalizations, it is estimated that 55% of patients with COPD do not receive all recommended care and that less than 50% of patients with asthma are well controlled.

The proposed study will evaluate the effectiveness of a novel model for pulmonary specialist-health coach consultations (PuSHCon) in its ability to increase access to specialty recommendations and the provision of evidence-based care for patients with chronic obstructive pulmonary disease (COPD) and/or asthma receiving care at federally qualified health centers (FQHCs). The specific aims of the study are to compare the use of evidence-based care and of patient reported outcomes 4 months after the consultation. In addition, the study will evaluate the cost per patient in each model to determine the model's effectiveness in increasing access and lowering cost.

The first aim of comparing the use of evidence-based care will be measured as the proportion of guideline-based recommendations that are ultimately received by the patients. The secondary endpoint for this aim will be measured through the proportion of patients receiving guideline-concordant medications at 4 months after consultation compared to baseline.

The second aim of the study regarding patient-reported outcomes will be measured primarily through the change in COPD and/or asthma related quality of life measures from baseline to 4 months post consultation. The secondary measure for this aim will look at changes in COPD and/or asthma specific symptom scores.

The third aim of the study is to assess the impact of this model on access to care and cost of care. Access will be measured by tracking the number of patients who successfully complete a consultation per month. Costs will be determined by calculating time spent per patients, as well as by health care utilization.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* At least 18 years of age
* Diagnosed with asthma or COPD
* Experiencing uncontrolled symptoms or exacerbations

Exclusion Criteria:

* Do not plan to attend primary care clinic for at least 3 months
* Already engaged in pulmonary specialty care (defined as at least one visit in last 12 months)
* Cognitive dysfunction that would prevent interaction with a health coach
* Not having a phone at which the participant can be reached

Primary outcomes:
measure: Receipt of recommended care
timeFrame: 16 weeks after enrollment
measure: Receipt of recommended medications
timeFrame: 16 weeks after enrollment
Secondary outcomes:
measure: Provider acceptance of recommended care
timeFrame: 16 weeks after enrollment
measure: Patient-Reported Disease-specific Quality of Life (for asthma and COPD)
timeFrame: 16 weeks after enrollment
measure: Medication adherence
timeFrame: 16 weeks after enrollment
measure: Patient-reported quality of care
timeFrame: 16 weeks after enrollment
measure: Disease specific symptoms score (COPD & Asthma)
timeFrame: 16 weeks after enrollment
measure: Proportion of patients who engaged in chronic lung disease education
timeFrame: 16 weeks after enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: St. Anthony Medical Clinic
state: California
city: San Francisco
country: United States
facility: Tom Waddell Urban Health Clinic
state: California
city: San Francisco
country: United States
facility: Potrero Hill Health Center
state: California
city: San Francisco
country: United States
facility: Family Health Center
state: California
city: San Francisco
country: United States
facility: Mission Neighborhood Health Center
state: California
city: San Francisco
country: United States
facility: Richard H. Fine People's Clinic (General Medicine Clinic)
state: California
city: San Francisco
country: United States
facility: Maxine Hall Health Center
state: California
city: San Francisco
country: United States
facility: Ocean Park Health Center
state: California
city: San Francisco
country: United States
facility: Southeast Health Center
state: California
city: San Francisco
country: United States
facility: Castro Mission Health Center
state: California
city: San Francisco
country: United States
facility: Silver Avenue Family Health Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rachel Willard-Grace, MPH
role: PRINCIPAL_INVESTIGATOR
References: