Pulmonary Specialist-Health Coach Consult Model Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03695276

Acronym

PuSHCon

Enrollment

328

Registered

2018-10-04

Start date

2020-10-20

Completion date

2025-01-31

Last updated

2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Asthma

Keywords

Health coaching, COPD, Asthma, Access to specialty care

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.

Interventions

BEHAVIORALPushCon 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.

BEHAVIORALUsual care

The standard of care, which usually means management within primary care.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Investigator)

Masking description

Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.

Intervention model description

Randomized controlled trial, with randomization at the individual level

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Medication Adherence	16 weeks after enrollment	Number and percentage of patients taking all controller inhalers as prescribed for at least 5 of the 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
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) with range of 0-100, where 0 is highest quality of life and 100 is lowest. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ\_download/sgrq-c-manual-april-2012.pdf)
Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score	16 weeks after enrollment	Score on St. George's Respiratory questionnaire (overall) with range of 0-100, where 0 is highest quality of life and 100 is lowest. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ\_download/sgrq-c-manual-april-2012.pdf)

Countries

United States

Participant flow

Participants by arm

Arm	Count
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,	165
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.	163
Total	328

Baseline characteristics

Characteristic	Usual Care	PuSHCon Model	Total
Age, Continuous	53.1 Years STANDARD_DEVIATION 14	51.9 Years STANDARD_DEVIATION 13.6	52.5 Years STANDARD_DEVIATION 13.8
Breathing-related quality of life	52.0 Scores on a scale STANDARD_DEVIATION 16.8	51.6 Scores on a scale STANDARD_DEVIATION 16.6	51.8 Scores on a scale STANDARD_DEVIATION 16.7
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants	59 Participants	115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants	106 Participants	213 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	9 Participants	7 Participants	16 Participants
Race (NIH/OMB) Black or African American	63 Participants	60 Participants	123 Participants
Race (NIH/OMB) More than one race	6 Participants	12 Participants	18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	3 Participants	5 Participants
Race (NIH/OMB) Unknown or Not Reported	63 Participants	59 Participants	122 Participants
Race (NIH/OMB) White	19 Participants	23 Participants	42 Participants
Sex/Gender, Customized Female	128 Participants	118 Participants	246 Participants
Sex/Gender, Customized Male	34 Participants	43 Participants	77 Participants
Sex/Gender, Customized Other	1 Participants	4 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 165	0 / 163
other Total, other adverse events	0 / 165	0 / 163
serious Total, serious adverse events	0 / 165	0 / 163

Outcome results

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