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Pulmonary Specialist-Health Coach Consult Model Study (PuSHCon)

Primary Purpose

COPD Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PushCon Model
Usual care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD Asthma focused on measuring Health coaching, COPD, Asthma, Access to specialty care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Anthony Medical Clinic
  • Tom Waddell Urban Health Clinic
  • Potrero Hill Health Center
  • Family Health CenterRecruiting
  • Mission Neighborhood Health Center
  • Richard H. Fine People's Clinic (General Medicine Clinic)
  • Maxine Hall Health CenterRecruiting
  • Ocean Park Health Center
  • Southeast Health Center
  • Castro Mission Health CenterRecruiting
  • Silver Avenue Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PuSHCon model

Usual care

Arm Description

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,

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.

Outcomes

Primary Outcome Measures

Receipt of recommended care
Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines
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

Secondary Outcome Measures

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
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)
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
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.
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)
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

Full Information

First Posted
October 2, 2018
Last Updated
August 21, 2023
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03695276
Brief Title
Pulmonary Specialist-Health Coach Consult Model Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Asthma
Keywords
Health coaching, COPD, Asthma, Access to specialty care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, with randomization at the individual level
Masking
Investigator
Masking Description
Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PuSHCon model
Arm Type
Experimental
Arm Description
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,
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PushCon Model
Other Intervention Name(s)
Pulmonary specialist-health coach consultation model
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
The standard of care, which usually means management within primary care.
Primary Outcome Measure Information:
Title
Receipt of recommended care
Description
Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines
Time Frame
16 weeks after enrollment
Title
Receipt of recommended medications
Description
Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study
Time Frame
16 weeks after enrollment
Secondary Outcome Measure Information:
Title
Provider acceptance of recommended care
Description
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
Time Frame
16 weeks after enrollment
Title
Patient-Reported Disease-specific Quality of Life (for asthma and COPD)
Description
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)
Time Frame
16 weeks after enrollment
Title
Medication adherence
Description
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
Time Frame
16 weeks after enrollment
Title
Patient-reported quality of care
Description
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.
Time Frame
16 weeks after enrollment
Title
Disease specific symptoms score (COPD & Asthma)
Description
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)
Time Frame
16 weeks after enrollment
Title
Proportion of patients who engaged in chronic lung disease education
Description
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
Time Frame
16 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abby Cabrera, MPH
Phone
628.206.6454
Email
abby.cabrera@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Willard-Grace, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Anthony Medical Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Tom Waddell Urban Health Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Potrero Hill Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Family Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Mission Neighborhood Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Richard H. Fine People's Clinic (General Medicine Clinic)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Maxine Hall Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Ocean Park Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Southeast Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu
Facility Name
Castro Mission Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta, MPH
Email
lucy.villalta@ucsf.edu
Facility Name
Silver Avenue Family Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Villalta
Email
lucy.villalta@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pulmonary Specialist-Health Coach Consult Model Study

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