Clinical trial NCT03653611: The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2)
Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
CAPTURE
Chronic Obstructive Pulmonary Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Michigan
name: National Jewish Health
name: Wake Forest University Health Sciences
name: Duke University
name: High Plains Research Network
name: L.A. Net Community Health Resource Network
name: Oregon Health and Science University
name: University of Minnesota
name: University of Kentucky
name: COPD Foundation
First posted: 2018-08-31
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practices participating in Aim 2, will be selected by each of their 5 affiliated PBRNs based upon willingness to participate and variability of primary care practice type within the PBRN. Differences in practice size, staffing, ownership, prior quality improvement engagement, geography, patient population socioeconomic status (SES) or languages spoken are among the among the selection criteria the PBRNs will utilize to choose.

Brief summary: This is a qualitative research exploration engaging clinical staff at all levels from 10 Practice-Based Research Networks (PBRNs) serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends, in the incorporation of a one-page, five-item questionnaire with selective PEF measurement (CAPTURE).

Detailed description: This is a prospective, multi-center qualitative study engaging clinical staff at all levels from primary care practices serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends.

The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.

This study will assess, using the RE-AIM approach, how real-word primary care practices might potentially use CAPTURE to: a) identify target populations (Reach); b) appraise optimal targeted respiratory history and symptoms consistent with clinically significant COPD (Effectiveness); c) integrate into practice workflow (Adoption); d) deliver changes and improvements to COPD care within the scope of real-world clinical practice (Implementation); and e) persist in use and quality over time (Maintenance).

Approximately 150 clinicians from 10 participating primary care practices will undergo detailed implementation investigation of the CAPTURE case finding model for clinically significant COPD. In addition, 200 enrolled participants will complete a 10-minute written CAPTURE opinion survey.

Using the RE-AIM framework and consistent phased qualitative analyses, this aim ascertains reach, impact, adoption, implementation and maintenance primary care feasibility recommendation characteristics of CAPTURE via pooled assessment of prescriber clinical staff, non-prescriber clinical staff, CAPTURE-eligible patients and local PBRN clinical quality improvement expertise from 10 primary care practices across 5 US regions.

Eligibility criteria: Inclusion Criteria:

Clinician Participants:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with availability and all study procedures for the duration of the study by the 10 practices (through PBRN recruitment) and their up to 15 clinicians within (through informed consent).
3. Male or female, aged 45 - 80 years

Patient participants \[200 participants enrolled in Aim 1 of the CAPTURE Study for an opinion survey\]:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 45 - 80 years.

Exclusion Criteria:

1. Clinician participants: current employment at practices participating in aims 1 and/or 3
2. Clinician participants: from practices providing fewer than 2 clinician participants
3. Patient participants: meeting the exclusion criteria for aims 1 and 3 (above)

Primary outcomes:
measure: Primary care clinician perspective on implementing CAPTURE into primary care practice.
timeFrame: Baseline to 2 years
Secondary outcomes:
measure: Primary care clinician knowledge about respiratory care at the provider level.
timeFrame: Baseline to 2 years
measure: Primary care clinician knowledge about respiratory care at the provider level.
timeFrame: Baseline to 2 years
measure: Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.
timeFrame: Baseline to 2 years
measure: Primary care clinician self-efficacy in provider-specific respiratory clinical care.
timeFrame: Baseline to 2 years
measure: Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.
timeFrame: Baseline to 2 years
measure: Existing COPD Clinical care operations within a variety of primary care practices.
timeFrame: Baseline to 2 years
measure: Existing COPD Clinical care operations within a variety of primary care practices.
timeFrame: Baseline to 2 years
measure: Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
timeFrame: Baseline to 2 years
measure: Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
timeFrame: Baseline to 2 years
measure: Patient comprehension of CAPTURE tool instructions and questions.
timeFrame: Baseline to 2 years
measure: Patient ease of completion of the CAPTURE tool.
timeFrame: Baseline to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LANet
state: California
city: Aurora
country: United States
facility: High Plains Research Network
state: Colorado
city: Miami
country: United States
facility: COPD Foundation
state: Florida
city: Charlotte
country: United States
facility: Atrium Healthcare
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Rural Practice-based Research Network (ORPRN)
state: Oregon
Study officials:
affiliation: Weill Medical College of Cornell University
name: Fernando J Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: