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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653611
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : July 13, 2020
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
University of Kentucky
COPD Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date June 26, 2018
First Posted Date August 31, 2018
Last Update Posted Date July 13, 2020
Actual Study Start Date July 30, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2)
Official Title The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Obstructive Pulmonary Disease (COPD)
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).
  • 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: Patient Opinion Surveys
    200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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
    Intervention: Other: Patient Opinion Surveys
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 12, 2020)
196
Original Estimated Enrollment
 (submitted: August 27, 2018)
350
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03653611
Other Study ID Numbers 1803019032-2
R01HL136682-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
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
  • University of Kentucky
  • COPD Foundation
Investigators
Principal Investigator: Fernando J Martinez, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date July 2020