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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03695276
Other study ID # 1R56HL143366-01
Secondary ID 1R01HL143366-01A
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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