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Pulmonary Specialist-Health Coach Consult Model Study (PuSHCon)

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
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

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 a pulmonary consultation under usual care and 180 patients will receive the PuSHCon model.

Condition or disease Intervention/treatment Phase
COPD Asthma Behavioral: PushCon Model Behavioral: Usual care Not Applicable

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 primarily through recommendations for changes in care made by the PSNP, specifically, the proportion of PSNP 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 (PSNP time versus HC time), as well as by health care utilization.

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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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: PuSHCon model
A health coach will contact patients referred by their primary care clinician for a pulmonary specialty visit. 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,
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

Active Comparator: Usual care
Patients referred by their primary care clinician for a pulmonary specialty consultation will receive a case review electronically or in person. The pulmonary specialist will send recommendations to the primary care clinician.
Behavioral: Usual care
Patients referred for pulmonary consultation will be scheduled for an in-person visit at the central hospital-based office. Recommendations will be provided to the primary care clinician. Implementation of those recommendations will rely on follow up of the primary care clinician.




Primary Outcome Measures :
  1. Receipt of recommended care [ Time Frame: 16 weeks after referral ]
    Numerator: Number of specialist recommendations implemented by the patient; Denominator: Number of recommendations made by specialist

  2. Receipt of recommended medications [ Time Frame: 16 weeks after referral ]
    Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study


Secondary Outcome Measures :
  1. Provider acceptance of recommended care [ Time Frame: 16 weeks after referral ]
    Number of specialist recommendations where provider took action; Denominator: Number of recommendations made by specialist

  2. Patient-Reported Disease-specific Quality of Life (for asthma and COPD) [ Time Frame: 16 weeks after referral ]
    Score on St. George's Respiratory questionnaire, 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 is multiplied by 100. Scores are provided for three subscales (symptoms, activity, and impacts) and a total score is also calculated. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf)

  3. Medication adherence [ Time Frame: 16 weeks after referral ]
    Mean number of days in which patient took all doses of controller medications as prescribed in last 7 days

  4. Patient-reported quality of care [ Time Frame: 16 weeks after referral ]
    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 the aspect of high quality chronic care. Subscales (patient activation, delivery system practice design, goal setting/tailoring, problem solving/contextual), and follow up/coordination are also a mean of respective questions on a 1-5 scale.

  5. Disease specific symptoms score (COPD & Asthma) [ Time Frame: 16 weeks after referral ]
    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)

  6. Proportion of patient referred who receive consultation [ Time Frame: 16 weeks after referral ]
    Numerator: Number of people receiving a consultation based on visit history; Denominator: Number of people referred for a consultation by PCP

  7. Time from referral to consultation [ Time Frame: Within 16 week follow up period ]
    Number of days from date of referral to date of consultation for each study arm.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish speaking
  • At least 18 years of age
  • Diagnosed with asthma or COPD
  • Experiencing uncontrolled symptoms or exacerbations
  • Referred to see a pulmonary specialist

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

Information from the National Library of Medicine

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


Contacts
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Contact: Abby Cabrera, MPH 628.206.6454 abby.cabrera@ucsf.edu

Locations
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United States, California
St. Anthony Medical Clinic
San Francisco, California, United States, 94102
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Tom Waddell Urban Health Clinic
San Francisco, California, United States, 94102
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Potrero Hill Health Center
San Francisco, California, United States, 94107
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Family Health Center
San Francisco, California, United States, 94110
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Mission Neighborhood Health Center
San Francisco, California, United States, 94110
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Richard H. Fine People's Clinic (General Medicine Clinic)
San Francisco, California, United States, 94110
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Maxine Hall Health Center
San Francisco, California, United States, 94115
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Ocean Park Health Center
San Francisco, California, United States, 94122
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Southeast Health Center
San Francisco, California, United States, 94124
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Silver Avenue Family Health Center
San Francisco, California, United States, 94134
Contact: Camilla Bykhovsky       camilla.bykhovsky@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rachel Willard-Grace, MPH University of California, San Francisco
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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: April 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Health coaching
COPD
Asthma
Access to specialty care
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases