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
|Condition or disease||Intervention/treatment||Phase|
|COPD Asthma||Behavioral: PushCon Model Behavioral: Usual care||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized controlled trial|
|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|
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.
- 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
- 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
- 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.
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
|Contact: Margae Knox, MPHfirstname.lastname@example.org|
|United States, California|
|UCSF - Zuckerberg San Francisco General Hospital||Not yet recruiting|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Rachel Willard-Grace, MPH||University of California, San Francisco|