COPD Asthma Clinical Trial
— PuSHConOfficial 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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Completed |
NCT05162157 -
Home Spirometry in Primary Care: an Implementation Study
|
||
Not yet recruiting |
NCT03249428 -
E-Cigarette Inner City RCT
|
N/A | |
Recruiting |
NCT05398133 -
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
|
||
Completed |
NCT03275935 -
Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)
|
N/A | |
Completed |
NCT05564156 -
Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases
|
N/A | |
Enrolling by invitation |
NCT03056066 -
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
|
||
Completed |
NCT03137303 -
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
|
Phase 3 | |
Completed |
NCT02985814 -
Identifying Patients With the COPD-Asthma Overlap Phenotype: Therapeutic Implications
|
N/A | |
Not yet recruiting |
NCT05732922 -
ORCHARD- Optimising Home Assessment of Rural Patients
|
N/A | |
Completed |
NCT05397275 -
The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
|
N/A | |
Completed |
NCT03739359 -
The Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery: A Double-blinded, Randomized Controlled Trial
|
N/A | |
Completed |
NCT03395418 -
Evaluation of the Right Use of Inhaled Therapeutics
|