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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— CAPTURE  

Official title:

The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653611
• Other study ID #: 1803019032-2
• Secondary ID: R01HL136682-01
• Status: Completed
• Start date: July 30, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• On-site Practice Assessment
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).
• Clinical Staff Questionnaires
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.
• Patient Opinion Surveys
200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.
• Modular online COPD Education
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).
• COPD in Primary Care/CAPTURE Introduction Focus Groups
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.

Locations

Country	Name	City	State
United States	High Plains Research Network	Aurora	Colorado
United States	Atrium Healthcare	Charlotte	North Carolina
United States	Duke University	Durham	North Carolina
United States	LANet	Los Angeles	California
United States	COPD Foundation	Miami	Florida
United States	Oregon Rural Practice-based Research Network (ORPRN)	Portland	Oregon

Sponsors (12)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary care clinician knowledge about respiratory care at the provider level.	Primary care clinician knowledge will be assessed using a questionnaire to self report about knowledge and beliefs regard Chronic Obstructive Pulmonary Disease (COPD) and COPD management.	Baseline to 2 years
Secondary	Primary care clinician knowledge about respiratory care at the provider level.	Primary care clinician knowledge will be assessed using two focus groups to self report on the staff's knowledge regarding respiratory care.	Baseline to 2 years
Secondary	Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.	Primary care clinician attitudes and beliefs will be assessed using a questionnaire to self report respiratory care in their current practice.	Baseline to 2 years
Secondary	Primary care clinician self-efficacy in provider-specific respiratory clinical care.	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.	Baseline to 2 years
Secondary	Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.	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.	Baseline to 2 years
Secondary	Existing COPD Clinical care operations within a variety of primary care practices.	COPD clinical care operations at various practices will be assessed using two focus groups to self report current COPD clinical care operations within primary care clinicians own practices.	Baseline to 2 years
Secondary	Existing COPD Clinical care operations within a variety of primary care practices.	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.	Baseline to 2 years
Secondary	Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.	Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.	Baseline to 2 years
Secondary	Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.	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.	Baseline to 2 years
Secondary	Patient comprehension of CAPTURE tool instructions and questions.	Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.	Baseline to 2 years
Secondary	Patient ease of completion of the CAPTURE tool.	Patients' ease of completion of the CAPTURE tool will be assessed using a CAPTURE opinion survey to self report ease of completion.	Baseline to 2 years