NURS 8730 Week 10 Project Oversight Memo Example

Memorandum

To: Chair, Quality Improvement Review Committee; DNP project chair

From: DNP student

Date: Month Day, Year

Re: Oversight for the nurse-led mobilization project: improvement review suffices for versions 1 and 2; version 3 needs a determination from the ethics board

Purpose

Not every project needs the same review. This memo reasons through which oversight the nurse-led early mobilization project in the ICU requires by describing three versions of it, each adding one feature, and showing how each addition changes the answer. The reasoning follows the account of improvement ethics in Lynn et al. (2007), which holds that improvement work has its own ethical requirements and should receive oversight proportionate to its risk, and that some improvement activities also meet the definition of research. The final version is the one I intend to carry out.

Version 1: The Protocol With Unit Measurement

What it does. Nurses screen ventilated patients each night against published consensus safety criteria (Hodgson et al., 2014), mobilize those who pass with respiratory therapist support and record the highest daily mobility level. The unit charts the results weekly and adjusts the protocol in improvement cycles.

Analysis. Every eligible patient receives the protocol as part of the unit's care. No one is assigned to a condition, nothing untested is introduced and the data are those the unit records anyway. The main risk is that of mobilization itself, which the safety criteria and stopping rules address, and that risk is part of clinical care that the unit's leaders are responsible for. Improvement ethics guidance treats this kind of activity as quality improvement that should go through the organization's improvement oversight, with clinical leaders accountable for its safety (Lynn et al., 2007).

Answer. The hospital's quality improvement review is sufficient.

Version 2: Adding Staff Interviews

What it adds. After two months, short interviews with eight nurses and four respiratory therapists about what makes mobilization easier or harder on a given shift, recorded and transcribed, to guide the next improvement cycles.

Analysis. The interviews collect information from staff, not patients, and their purpose is to improve the protocol in this unit. But they introduce new risks that version 1 did not have: staff may say things critical of colleagues or managers, and a recorded interview could identify them. Participation must therefore be voluntary, consent must be obtained, recordings must be stored securely and destroyed after transcription and the nurse manager must not know who took part or see identifiable transcripts.

Answer. Still quality improvement, reviewable by the quality improvement committee, but with written safeguards for staff that the committee should approve explicitly.

The interview topics were also reviewed for risk. Questions about what helps or hinders mobilization on a shift could lead staff to describe colleagues who refuse to participate or physicians who override screens. The interview guide will therefore ask about situations rather than people, and the interviewer will remind participants at the start not to name colleagues. Transcripts will be read for themes by the project lead alone, and any quotation used in a report will be checked with the participant first.

Version 3: Adding an Intention to Publish and Present Outside the Hospital

What it adds. An intention, from the start, to present the run charts and interview themes at a regional critical care conference and submit a report for publication following SQUIRE 2.0 (Ogrinc et al., 2016).

Analysis. Planning to publish is not, on its own, what separates improvement from research, and the improvement ethics literature no longer treats it as decisive (Lynn et al., 2007). But publication changes two things. The staff interview material, quoted outside the hospital, carries greater risk of identifying participants in a small unit where everyone knows who works nights. And many journals ask authors to state how the project was reviewed by an ethics body, and accept a formal determination that a project is not human subjects research. The hospital's own policy also requires that any project intended for external publication that involves interviews be submitted to its ethics board for a determination.

Answer. The project should be submitted to the hospital's ethics board for a determination. The likely outcome is a determination that full board review is unnecessary for this improvement work, with conditions on the interview data. But the determination should come from the board, not from the project team.

Recommendation

I intend to carry out version 3. I recommend that the quality improvement committee approve the protocol and the staff interview safeguards now, so that the protocol can begin on schedule, and that the ethics board determination be requested at the same time, before any interviews are recorded. If the board requires changes to the interview procedure, the interviews will be delayed but the protocol will not. I will report the committee's approval and the board's determination in the methods of any publication.

Running the two reviews in parallel has a cost: the project lead must prepare two submissions at once, and the board may ask questions that delay the interviews by a month or more. The alternative, waiting for the board's determination before starting the protocol, would delay patient care changes that need no board review at all. Keeping the two decisions separate protects the protocol's schedule while giving the board full authority over the part of the project that needs it.

References

Hodgson, C. L., Stiller, K., Needham, D. M., Tipping, C. J., Harrold, M., Baldwin, C. E., Bradley, S., Berney, S., Caruana, L. R., Elliott, D., Green, M., Haines, K., Higgins, A. M., Kaukonen, K.-M., Leditschke, I. A., Nickels, M. R., Paratz, J., Patman, S., Skinner, E. H., . . . Webb, S. A. (2014). Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Critical Care, 18(6), Article 658. https://doi.org/10.1186/s13054-014-0658-y

Lynn, J., Baily, M. A., Bottrell, M., Jennings, B., Levine, R. J., Davidoff, F., Casarett, D., Corrigan, J., Fox, E., Wynia, M. K., Agich, G. J., O'Kane, M., Speroff, T., Schyve, P., Batalden, P., Tunis, S., Berlinger, N., Cronenwett, L., Fitzmaurice, J. M., . . . James, B. (2007). The ethics of using quality improvement methods in health care. Annals of Internal Medicine, 146(9), 666-673. https://doi.org/10.7326/0003-4819-146-9-200705010-00155

Ogrinc, G., Davies, L., Goodman, D., Batalden, P., Davidoff, F., & Stevens, D. (2016). SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality & Safety, 25(12), 986-992. https://doi.org/10.1136/bmjqs-2015-004411