Pulmonary Specialist-Health Coach Consult Model Study

COPD Asthma Clinical Trial

— PuSHCon  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695276
• Other study ID #: 1R56HL143366-01
• Secondary ID: 1R01HL143366-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Abby Cabrera, MPH
• Phone: 628.206.6454
• Email: abby.cabrera[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD Asthma

Intervention

Behavioral:
• PushCon Model
Pulmonary specialist consultation facilitated by a trained health coach, who will gather information from the patient and medical record prior to the consultation and will using health coaching skills to support implementation of recommended care.
• Usual care
The standard of care, which usually means management within primary care.

Locations

Country	Name	City	State
United States	Castro Mission Health Center	San Francisco	California
United States	Family Health Center	San Francisco	California
United States	Maxine Hall Health Center	San Francisco	California
United States	Mission Neighborhood Health Center	San Francisco	California
United States	Ocean Park Health Center	San Francisco	California
United States	Potrero Hill Health Center	San Francisco	California
United States	Richard H. Fine People's Clinic (General Medicine Clinic)	San Francisco	California
United States	Silver Avenue Family Health Center	San Francisco	California
United States	Southeast Health Center	San Francisco	California
United States	St. Anthony Medical Clinic	San Francisco	California
United States	Tom Waddell Urban Health Clinic	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of recommended care	Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines	16 weeks after enrollment
Primary	Receipt of recommended medications	Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study	16 weeks after enrollment
Secondary	Provider acceptance of recommended care	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	16 weeks after enrollment
Secondary	Patient-Reported Disease-specific Quality of Life (for asthma and COPD)	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)	16 weeks after enrollment
Secondary	Medication adherence	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	16 weeks after enrollment
Secondary	Patient-reported quality of care	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.	16 weeks after enrollment
Secondary	Disease specific symptoms score (COPD & Asthma)	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)	16 weeks after enrollment
Secondary	Proportion of patients who engaged in chronic lung disease education	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	16 weeks after enrollment