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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: COPD in Primary Care/CAPTURE Introduction Focus Groups; Other: Clinical Staff Questionnaires; Other: Patient Opinion Surveys; Other: On-site Practice Assessment; Other: Modular online COPD Education

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT03653611

R01HL136682-01 (U.S. NIH Grant/Contract)

1803019032-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 196 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

196 participants in 2 patient groups

Clinician Participants

Description:

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.

Treatment:

Other: On-site Practice Assessment

Other: Modular online COPD Education

Other: Clinical Staff Questionnaires

Other: COPD in Primary Care/CAPTURE Introduction Focus Groups

Patient Participants

Description:

200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey

Treatment:

Other: Patient Opinion Surveys