The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2)

NCT03653611 | Completed DMC

• 2 other identifiers: 1803019032-2R01HL136682-01
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 6

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; CAPTURE; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Primary care clinician perspective on implementing CAPTURE into primary care practice.

  Primary care clinician perspective on implementing CAPTURE will be assessed using the RE-AIM approach in two focus group sessions consisting of clinical staff self-reporting current clinical practices, the process for implementing a new tool into practice and review of the CAPTURE tool.

  Baseline to 2 years

Secondary Outcomes (11)

• Primary care clinician knowledge about respiratory care at the provider level.

  Baseline to 2 years

• Primary care clinician knowledge about respiratory care at the provider level.

  Baseline to 2 years

• Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.

  Baseline to 2 years

• Primary care clinician self-efficacy in provider-specific respiratory clinical care.

  Baseline to 2 years

• Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.

  Baseline to 2 years

Study Arms (2)

Clinician Participants

Two Aim 2 practices are 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.

Other: On-site Practice Assessment; Other: Clinical Staff Questionnaires; Other: Modular online COPD Education; Other: COPD in Primary Care/CAPTURE Introduction Focus Groups

Patient Participants

200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey

Other: Patient Opinion Surveys

Interventions

On-site Practice Assessment OTHER

The assessment takes place in three parts; the pre-observation practice overview (conducted with the 2 practice clinicians - 60 minutes), the ½ day practice workflow observation (observation by one member of the Aim 2 research team of common and testing areas used for the respiratory patient). There is no patient engagement and no collection of patient-specific identification or health information), and the post-observation practice summary (conducted with the same 2 practice clinicians - 30 minutes).

Clinician Participants

Clinical Staff Questionnaires OTHER

Written or on-line questionnaires are provided to participating and consented staff personnel at two practice levels -- Non-Prescribing clinical (also known as "support") staff and Prescribing (PR) clinical (also known as "provider") staff.

Clinician Participants

Patient Opinion Surveys OTHER

200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.

Patient Participants

Modular online COPD Education OTHER

Access to free, COPD on-line, continuing education is provided for all clinical staff at each practice. Each module will take 20 minutes or less. Aim 2 clinician participant access and completion of COPD education modules is assessed by clinician questionnaires and focus group item response over 12 months (between months 2 and 14 of Aim 2 timeline).

Clinician Participants

COPD in Primary Care/CAPTURE Introduction Focus Groups OTHER

Two 45 to 60-minute focus group discussions occur at each Aim 2 practice. Focus groups are informed by practice demographics, practice assessment data, as well as patient opinion from CAPTURE surveys and past CAPTURE study. Focus group candidate themes and prompts are developed for non-prescribing clinical staff (NPR) and prescribing clinical staff (PR) and are presented at separate on-site focus group sessions to allow more detailed discussion of role responsibility in the context of daily practice workflow.

Clinician Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinician Participants:
• Provision of signed and dated informed consent form.
• 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).
• Male or female, aged 45 - 80 years
• Patient participants \[200 participants enrolled in Aim 1 of the CAPTURE Study for an opinion survey\]:
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 45 - 80 years.

You may not qualify if:

• Clinician participants: current employment at practices participating in aims 1 and/or 3
• Clinician participants: from practices providing fewer than 2 clinician participants

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Michigan: collaborator
• National Jewish Health: collaborator
• Wake Forest University Health Sciences: collaborator
• Duke University: collaborator
• High Plains Research Network: collaborator
• L.A. Net Community Health Resource Network: collaborator
• Oregon Health and Science University: collaborator
• University of Minnesota: collaborator
• University of Kentucky: collaborator
• COPD Foundation: collaborator

Study Sites (6)

LANet

Los Angeles, California, 90802, United States

Location

High Plains Research Network

Aurora, Colorado, 80054, United States

Location

COPD Foundation

Miami, Florida, 33134, United States

Location

Atrium Healthcare

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Oregon Rural Practice-based Research Network (ORPRN)

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando J Martinez, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 31, 2018
• Study Start: July 30, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 22, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)