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

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ClinicalTrials.gov Identifier: NCT03653611
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
Atrium Health
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Kentucky
COPD Foundation
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD) Other: On-site Practice Assessment Other: Clinical Staff Questionnaires Other: Patient Opinion Surveys Other: Modular online COPD Education Other: COPD in Primary Care/CAPTURE Introduction Focus Groups

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 : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.
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).

Other: 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.

Other: 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).

Other: 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.

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




Primary Outcome Measures :
  1. Primary care clinician perspective on implementing CAPTURE into primary care practice. [ Time Frame: 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 :
  1. Primary care clinician knowledge about respiratory care at the provider level. [ Time Frame: Baseline to 2 years ]
    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.

  2. Primary care clinician knowledge about respiratory care at the provider level. [ Time Frame: 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.

  3. Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice. [ Time Frame: 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.

  4. Primary care clinician self-efficacy in provider-specific respiratory clinical care. [ Time Frame: 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.

  5. Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice. [ Time Frame: 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.

  6. Existing COPD Clinical care operations within a variety of primary care practices. [ Time Frame: Baseline to 2 years ]
    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.

  7. Existing COPD Clinical care operations within a variety of primary care practices. [ Time Frame: 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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. Patient comprehension of CAPTURE tool instructions and questions. [ Time Frame: Baseline to 2 years ]
    Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.

  11. Patient ease of completion of the CAPTURE tool. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653611


Contacts
Contact: Randall Brown, MD, MPH 734-763-1549 rbrownmd@umich.edu

Locations
United States, California
LANet Not yet recruiting
Los Angeles, California, United States, 90802
Contact: Lyndee Knox, PhD    562-434-2000    lyndee.knox@gmail.com   
United States, Colorado
High Plains Research Network Not yet recruiting
Aurora, Colorado, United States, 80054
Contact: Linda Zittleman, MSPH    303-724-9716    linda.zittleman@ucdenver.edu   
United States, Florida
COPD Foundation Not yet recruiting
Miami, Florida, United States, 33134
Contact: Barbara Yawn, MD       Byawn@copdfoundation.org   
United States, North Carolina
Atrium Healthcare Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Hazel Tapp, PhD    704-304-7120    Hazel.Tapp@atriumhealth.org   
Duke University Recruiting
Durham, North Carolina, United States, 27701
Contact: Rowena Dolor, MD    919-668-8627    rowena.dolor@duke.edu   
United States, Oregon
Oregon Rural Practice-based Research Network (ORPRN) Recruiting
Portland, Oregon, United States, 97239
Contact: Lyle Fagan, MD       fagnanl@ohsu.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
Atrium Health
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Kentucky
COPD Foundation
Investigators
Principal Investigator: Fernando J Martinez, MD Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03653611     History of Changes
Other Study ID Numbers: 1803019032-2
R01HL136682-01 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
COPD
CAPTURE
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases