Pulmonary Specialist-Health Coach Consult Model Study
- Conditions
- COPD Asthma
- Interventions
- Behavioral: PushCon ModelBehavioral: Usual care
- Registration Number
- NCT03695276
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
- English or Spanish speaking
- At least 18 years of age
- Diagnosed with asthma or COPD
- Experiencing uncontrolled symptoms or exacerbations
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PuSHCon model PushCon Model A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts, Usual care Usual care Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time.
- Primary Outcome Measures
Name Time Method Receipt of recommended care 16 weeks after enrollment Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines
Receipt of recommended medications 16 weeks after enrollment Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study
- Secondary Outcome Measures
Name Time Method Medication adherence 16 weeks after enrollment Mean number of days in which patient took all doses of controller medications (i.e., inhalers taken daily to prevent flare ups) as prescribed in last 7 days
Patient-reported quality of care 16 weeks after enrollment Mean score on Patient Assessment of Chronic Illness Care (PACIC) measure, with response options ranging from 1 (Almost never) to 5 (Almost Always). The scale is scored as an overall mean (1-5), with higher scores indicating a more frequent presence of high quality care. Four PACIC subscales (patient activation, delivery system practice design, goal setting/tailoring, problem solving/contextual), plus follow up/coordination are also represented by means of respective items.
Provider acceptance of recommended care 16 weeks after enrollment Number of guideline-based recommendations where provider took action (e.g., prescribed or referred patient for care); Denominator: Number of minimal recommendations based on GOLD/GINA guidelines
Patient-Reported Disease-specific Quality of Life (for asthma and COPD) 16 weeks after enrollment Score on St. George's Respiratory questionnaire, based on weighted scoring algorithm; a sum is taken of the weighted responses, divided by the sum of weights for all items in the component, and then multiplied by 100. Mean scores are provided for three subscales (symptoms, activity, and impacts) in addition to total score. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf)
Proportion of patients who engaged in chronic lung disease education 16 weeks after enrollment Numerator: Number of people who engage with at least one existing resources such as group education classes or pulmonary care; Denominator: Number of people enrolled in the study
Disease specific symptoms score (COPD & Asthma) 16 weeks after enrollment Score on St. George's Respiratory Questionnaire symptom subscale, based on weighted scoring algorithm; a sum is taken of the weighted responses, is divided by the sum of weights for all items in the component , and then multiplied by 100. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf)
Trial Locations
- Locations (11)
St. Anthony Medical Clinic
🇺🇸San Francisco, California, United States
Tom Waddell Urban Health Clinic
🇺🇸San Francisco, California, United States
Family Health Center
🇺🇸San Francisco, California, United States
Potrero Hill Health Center
🇺🇸San Francisco, California, United States
Mission Neighborhood Health Center
🇺🇸San Francisco, California, United States
Richard H. Fine People's Clinic (General Medicine Clinic)
🇺🇸San Francisco, California, United States
Maxine Hall Health Center
🇺🇸San Francisco, California, United States
Ocean Park Health Center
🇺🇸San Francisco, California, United States
Castro Mission Health Center
🇺🇸San Francisco, California, United States
Southeast Health Center
🇺🇸San Francisco, California, United States
Silver Avenue Family Health Center
🇺🇸San Francisco, California, United States