- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653611
The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2) (CAPTURE)
The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90802
- LANet
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Colorado
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Aurora, Colorado, United States, 80054
- High Plains Research Network
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Florida
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Miami, Florida, United States, 33134
- COPD Foundation
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Atrium Healthcare
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Durham, North Carolina, United States, 27701
- Duke University
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Rural Practice-based Research Network (ORPRN)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Clinician participants: current employment at practices participating in aims 1 and/or 3
- Clinician participants: from practices providing fewer than 2 clinician participants
- Patient participants: meeting the exclusion criteria for aims 1 and 3 (above)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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).
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.
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).
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.
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Patient Participants
200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey
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200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary care clinician perspective on implementing CAPTURE into primary care practice.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary care clinician knowledge about respiratory care at the provider level.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Primary care clinician knowledge about respiratory care at the provider level.
Time Frame: Baseline to 2 years
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Primary care clinician knowledge will be assessed using two focus groups to self report on the staff's knowledge regarding respiratory care.
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Baseline to 2 years
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Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.
Time Frame: Baseline to 2 years
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Primary care clinician attitudes and beliefs will be assessed using a questionnaire to self report respiratory care in their current practice.
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Baseline to 2 years
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Primary care clinician self-efficacy in provider-specific respiratory clinical care.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Existing COPD Clinical care operations within a variety of primary care practices.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Existing COPD Clinical care operations within a variety of primary care practices.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Time Frame: Baseline to 2 years
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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.
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Baseline to 2 years
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Patient comprehension of CAPTURE tool instructions and questions.
Time Frame: Baseline to 2 years
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Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.
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Baseline to 2 years
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Patient ease of completion of the CAPTURE tool.
Time Frame: Baseline to 2 years
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Patients' ease of completion of the CAPTURE tool will be assessed using a CAPTURE opinion survey to self report ease of completion.
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Baseline to 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fernando J Martinez, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1803019032-2
- R01HL136682-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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