Pulmonary Specialist-Health Coach Consult Model Study (PuSHCon)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03695276 |
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Recruitment Status :
Recruiting
First Posted : October 4, 2018
Last Update Posted : December 8, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD Asthma | Behavioral: PushCon Model Behavioral: Usual care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized controlled trial, with randomization at the individual level |
| Masking: | Single (Investigator) |
| Masking Description: | Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups. |
| Primary Purpose: | Health Services Research |
| 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 |
| Actual Study Start Date : | October 20, 2020 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | September 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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,
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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.
Other Name: Pulmonary specialist-health coach consultation model |
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Active Comparator: 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.
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Behavioral: Usual care
The standard of care, which usually means management within primary care. |
- Receipt of recommended care [ Time Frame: 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 [ Time Frame: 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
- Provider acceptance of recommended care [ Time Frame: 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) [ Time Frame: 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)
- Medication adherence [ Time Frame: 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 [ Time Frame: 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.
- Disease specific symptoms score (COPD & Asthma) [ Time Frame: 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)
- Proportion of patients who engaged in chronic lung disease education [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695276
| Contact: Abby Cabrera, MPH | 628.206.6454 | abby.cabrera@ucsf.edu |
| United States, California | |
| St. Anthony Medical Clinic | Not yet recruiting |
| San Francisco, California, United States, 94102 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Tom Waddell Urban Health Clinic | Not yet recruiting |
| San Francisco, California, United States, 94102 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Potrero Hill Health Center | Not yet recruiting |
| San Francisco, California, United States, 94107 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Family Health Center | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Mission Neighborhood Health Center | Not yet recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Richard H. Fine People's Clinic (General Medicine Clinic) | Not yet recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Maxine Hall Health Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Ocean Park Health Center | Not yet recruiting |
| San Francisco, California, United States, 94122 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Southeast Health Center | Not yet recruiting |
| San Francisco, California, United States, 94124 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Silver Avenue Family Health Center | Not yet recruiting |
| San Francisco, California, United States, 94134 | |
| Contact: Rebeca Garcia rebeca.garcia@ucsf.edu | |
| Principal Investigator: | Rachel Willard-Grace, MPH | University of California, San Francisco |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT03695276 |
| Other Study ID Numbers: |
1R56HL143366-01 ( U.S. NIH Grant/Contract ) 1R01HL143366-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 4, 2018 Key Record Dates |
| Last Update Posted: | December 8, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Health coaching COPD Asthma Access to specialty care |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |