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Pulmonary Specialist-Health Coach Consult Model Pilot (PuSHCon)

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ClinicalTrials.gov Identifier: NCT03695276
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : March 6, 2019
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. A limited number of patients (50) from two clinics will be enrolled in the pilot study; 25 patients from one clinic will receive a pulmonary consultation under usual care and 25 patients from the other clinic 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 is a one-year cluster randomized controlled pilot trial comparing the Pulmonary specialist-health coach (PuSHCon) model to usual care for primary care patients referred for a consultation with a pulmonary specialist. This study is intended to prepare the way for a larger randomized controlled trial comparing the PuSHCon model to usual care for primary care patients referred for a consultation with a pulmonary specialist.

The investigators will use a combination of quantitative and qualitative methods to assess the implementation the PuSHCon model and measurement of patient-centered outcomes (Specific Aim 1) and the impact of PuSHCon model on patient reported quality of care, satisfaction, and patient receipt of care recommended by the pulmonary specialist (Specific Aim 2). The results of the current study will provide initial enrollment for a subsequent 5 year randomized controlled trial.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
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 : March 13, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

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 visit will be scheduled to see a pulmonary specialist, who will send recommendations to the primary care clinician. Implementation of the recommendations will be the responsibility of 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


Other Outcome Measures:
  1. 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)

  2. 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

  3. Patient-reported quality of care [ Time Frame: 16 weeks after referral ]
    Mean score on 11-item 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.

  4. 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)

  5. 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

  6. 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

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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 last 18 years of age
  • Diagnosed with asthma or COPD
  • 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: Margae Knox, MPH 415.206.6454 margae.knox@ucsf.edu

Locations
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United States, California
UCSF - Zuckerberg San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
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     History of Changes
Other Study ID Numbers: 1R56HL143366-01 ( U.S. NIH Grant/Contract )
1R56HL143366-01 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
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
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases