Ludden, Thomas http://orcid.org/0000-0001-5217-0229
O’Hare, Katherine
Shade, Lindsay
Reeves, Kelly
Patterson, Charity G.
Tapp, Hazel
Clinical trials referenced in this document:
Documents that mention this clinical trial
Implementation of Coach McLungsSM into primary care using a cluster randomized stepped wedge trial design
https://doi.org/10.1186/s12911-022-02030-1
Funding for this research was provided by:
NHLBI Division of Intramural Research (1R01HL151854-01A1)
Article History
Received: 4 August 2022
Accepted: 22 October 2022
First Online: 4 November 2022
Declarations
:
: The Atrium Health Institutional Review Board approved the protocol under expedited review on July 28, 2021(Protocol Number: IRB00082608). Version 2 Approved May 2, 2022. Except for the key informant interviews, the Institutional Review Board classified the study as quality improvement since all patients will receive the study intervention as part of usual care so informed consent was not deemed necessary for these participants. Verbal consent will be obtained for those participants involved in key informant interviews. The data for the key information interview we will be collecting will not be associated with any PHI identifiers. Participants will only be identified by role such as being listed as patient, caregiver, provider or staff. The research team/clinical staff will provide the participants with an informational leaflet about the purpose of the study and what they will be asked to do. Every participant will be read a statement assuring them that they can decide whether or not they wish to participate in the interviews and can withdraw from the study at any time without harming their relationships with Atrium Health. The study presents no more than minimal risk of harm to subjects and a formal signed consent would result in the collection of more PHI than is actually necessary. The only documentation linking the participant to the study would be a signed consent/assent.
: Not applicable.
: The authors declare that they have no competing interests.