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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: Patient Opinion Surveys; Other: On-site Practice Assessment; Other: Clinical Staff Questionnaires; Other: Modular online COPD Education; Other: COPD in Primary Care/CAPTURE Introduction Focus Groups

• Registration Number: NCT03653611
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study First Submitted: 2018-06-26
• Study Start: 2018-07-30
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-31
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-07
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinician Participants	COPD in Primary Care/CAPTURE Introduction Focus Groups	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.
Patient Participants	Patient Opinion Surveys	200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey
Clinician Participants	On-site Practice Assessment	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.
Clinician Participants	Clinical Staff Questionnaires	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.
Clinician Participants	Modular online COPD Education	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.

Primary Outcome Measures

Name	Time	Method
Primary care clinician perspective on implementing CAPTURE into primary care practice.	Baseline to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.	Baseline to 2 years	Primary care clinician attitudes and beliefs will be assessed using a questionnaire to self report respiratory care in their current practice.
Patient comprehension of CAPTURE tool instructions and questions.	Baseline to 2 years	Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.
Primary care clinician knowledge about respiratory care at the provider level.	Baseline to 2 years	Primary care clinician knowledge will be assessed using two focus groups to self report on the staff's knowledge regarding respiratory care.
Existing COPD Clinical care operations within a variety of primary care practices.	Baseline to 2 years	Details of COPD clinical care operations at various practices will be assessed using a questionnaire to self report current COPD clinical care operations within primary care clinicians own practices.
Patient ease of completion of the CAPTURE tool.	Baseline to 2 years	Patients' ease of completion of the CAPTURE tool will be assessed using a CAPTURE opinion survey to self report ease of completion.
Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.	Baseline to 2 years	Primary care clinician attitudes and beliefs regarding quality improvement and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.
Primary care clinician self-efficacy in provider-specific respiratory clinical care.	Baseline to 2 years	Primary care clinician self-efficacy will be assessed using two focus groups to self report on the staff's perspective regarding self-efficacy of provider-specific respiratory practices.
Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.	Baseline to 2 years	Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using a prescriber questionnaire to self report attitude and beliefs.

Trial Locations

Locations (6)

Duke University; 🇺🇸 Durham, North Carolina, United States

LANet; 🇺🇸 Los Angeles, California, United States

High Plains Research Network; 🇺🇸 Aurora, Colorado, United States

COPD Foundation; 🇺🇸 Miami, Florida, United States

Atrium Healthcare; 🇺🇸 Charlotte, North Carolina, United States

Oregon Rural Practice-based Research Network (ORPRN); 🇺🇸 Portland, Oregon, United States