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Pulmonary Specialist-Health Coach Consult Model Pilot (PuSHCon)

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ClinicalTrials.gov Identifier: NCT03695276
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE April 3, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Receipt of recommended care [ Time Frame: 3 months after referral ]
Number of specialist recommendations implemented by the patient; Denominator: Number of recommendations made by specialist
Change History Complete list of historical versions of study NCT03695276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Acceptability [ Time Frame: At least 3 months after model implementation ]
    Response of staff and clinicians at pilot site to question, "On a scale of 0 to 10, with 10 being the highest, how likely are you to recommend this model to colleagues?"
  • Provider acceptance of recommended care [ Time Frame: 3 months after referral ]
    Number of specialist recommendations where provider took action; Denominator: Number of recommendations made by specialist
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2019)
  • 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)
  • 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
  • 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.
  • 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)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 2, 2018)
  • Patient-Reported General Quality of Life [ Time Frame: 3 months after referral ]
    Mean score on EurQol 5 Dimension-5 Level (EQ-5D-5L) (Scoring: select 1 of 5 levels on each of dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - score is mean across 5 dimensions, where higher scores on a 1-5 scale mean worse quality of life) and response to a single item question "How good or bad is your health today?" scored on a 0-100 point scale, where higher scores mean better health.
  • Medication adherence [ Time Frame: 3 months after referral ]
    Numerator: Mean number of missed doses in last week; Denominator: Total number of doses prescribed
  • Patient-reported quality of care [ Time Frame: 3 months 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 systm practice design, goal setting/tailoring, problem solving/contextual), and follow up/coordination are also a mean of respective questions on a 1-5 scale.
  • Disease specific quality of life score (COPD) [ Time Frame: 3 months after referral, for patients with COPD ]
    Score on St. George's Respiratory questionnaire, based on weighted scoring algorithm; a sum is taken of the weighted responses, is multiplied by 100, and then is divided by the sum of weights for all items in the component. 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)
  • Disease specific quality of life score (Asthma) [ Time Frame: 3 months after referral, for patients with asthma ]
    Mean score on Mini Asthma Quality of Life Questionnaire (Mini AQLQ): Scores range from 0-6, with lower scores indicative of worse asthma quality of life.The Mini AQLQ score is calculated as a mean of item scores. Subscales scores (symptoms, environment, emotions, activity) are calculated as means of their respective items.
  • Disease specific symptoms score (COPD) [ Time Frame: 3 months after referral, for patients with COPD ]
    Sum score on eight items of COPD Assessment Test (CAT): each items is scored 0-5, with 5 indicative of greater symptoms; a total is taken across the 8 items, for a total of 0-40 points).
  • Disease specific symptoms score (Asthma) [ Time Frame: 3 months after referral, for patients with asthma ]
    Summary score on the Asthma Symptoms Utility Index (ASUI): The ASUI is a 10-item self-administered questionnaire with four questions on asthma symptoms (cough, wheeze, shortness of breath, and awakening at night) and one question about side effects of asthma medications. For each symptom, there are two dimensions - frequency and severity. The questionnaire is based on a two week patient recall of symptoms and is scored using a previously derived multi-attribute utility function. The summary score is a continuous scale from 0 to 1, with lower scores indicating worse asthma symptoms.
  • Proportion of patient referred who receive consultation [ Time Frame: 3 months after referral ]
    Numerator: Number of people receiving a consultation based on visit history; Denominator: Number of people referred for a consultation by PCP
 
Descriptive Information
Brief Title  ICMJE Pulmonary Specialist-Health Coach Consult Model Pilot
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE COPD Asthma
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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,
    Intervention: Behavioral: PushCon 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.
    Intervention: Behavioral: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margae Knox, MPH 415.206.6454 margae.knox@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03695276
Other Study ID Numbers  ICMJE 1R56HL143366-01( U.S. NIH Grant/Contract )
1R56HL143366-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Rachel Willard-Grace, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP