Table 1.
Implementation Outcome | Quantitative Results | Qualitative Results with Example Quotes | Implication for Future RCT |
---|---|---|---|
Acceptability of an RCT evaluating APPS | 57% of clinicians perceive randomization to control group unacceptable | Clinicians report perceived lack of equipoise for prone positioning, lack of alternatives: “[Avoiding proning] is a little bit more challenging to me because we obviously don’t have a lot of things that work for COVID…I think a lot of the patients do respond to going to a prone position as far as their oxygen saturation levels, so, telling people to not do that, I do have a little hesitation with that.” |
May hinder recruitment or lead to selection bias; consider clinician education strategy or switch to nontraditional (e.g., quasi-experimental) trial design |
Adoption of an RCT evaluating APPS | 74% of physicians assigned to APPS prescribed the intervention to eligible patients | May require modifying intervention to encourage uptake, anticipate dilution of treatment effect in intention-to-treat analyses | |
Appropriateness of an RCT evaluating APPS | 71% of clinicians reported that trial intervention has become usual care | Consider organizational education strategy to reinforce equipoise or quasi-experimental design | |
Effectiveness of an RCT evaluating APPS | Direction of research outcomes favored prone positioning. 100% of respondents endorsed ICU use and/or advanced respiratory support rates to be relevant and patient-centered primary outcome |
Patients subjectively felt that prone positioning improved their breathing: “I mean, [proning] did work.” “Yes. [Proning] actually helps, a lot.” “Thank God, I feel better now.” |
Further investigation of prone positioning for nonintubated patients in larger studies likely warranted; potential patient-centered outcomes might include ICU or advanced respiratory support use |
Equity of an RCT evaluating APPS | Lower rates of adherence among Black (19%) compared with white (56%) and non-Black Hispanic (71%) patients | Develop culturally tailored approaches to reduce disparities in adherence | |
Feasibility of an RCT evaluating APPS | 95% enrollment rate (only 2 patients met exclusion criteria). 98% of patients completed the study. Only 2 of 27 patients had documentation of prone position duration. Outcome data collection: no missing data for ICU transfer, advanced respiratory support, or mortality |
Nurses reported adherence to a strict positioning schedule to be challenging owing to complexities of care environment: “Working on the COVID unit is just so unpredictable and everybody can be fine one minute and the next they are not. So, we could say at 2:00 we are going to prone all of our patients for 1 h; however, at 2:00, everything can go awry and we get nobody proned, and then it would be completely off schedule.…So, there would definitely be a lot of challenges to it.” |
Tailor strategies to reduce complexity and increase flexibility of the intervention delivery protocol. Traditional RCTs with active data collection or novel approaches such as smart phone applications and patient-reported measures will be needed if reliable estimates of prone duration are desired. Otherwise, pragmatic trials should not plan specific analyses around these data |
Fidelity of an RCT evaluating APPS | 50% of patients had protocol violations/crossovers. 0% of patients managed the 12- to 16-h prone target time suggested by clinicians. Patients estimated spending between 10 and 120 min a day in prone position |
Patients perceived prone positioning to be difficult: “Just that at the time, in the condition that my body was in, I could not bear it for too long with my back pain. So, I had to turn a lot.” |
Will require strategies to enhance organizational and individual buy-in and improve comfort/tolerability. Consider more flexible prone time targets than those recommended in mechanically ventilated patients. Anticipate dilution of treatment effect, plan education strategy to clinicians to limit crossovers |
Penetration of an RCT evaluating APPS | No patients experienced intubation or death during hospitalization | Adapt recruitment strategies, may require inclusion of nonintubated patients admitted to ICU |
Definition of abbreviations: APPS = Awake Prone Positioning Strategy; COVID = coronavirus disease; ICU = intensive care unit; RCT = randomized controlled trial.