Are palliative care inpatients willing to be recruited to a study exploring the use of a technical device to assess level of consciousness? An observational study for I-CAN-CARE

Background: Previous I-CAN-CARE research found that clinicians considered that palliative care patients would be unwilling to participate in research using a technical device (the Bispectral index (BIS)) for monitoring consciousness, owing to the visual impact and apparent invasiveness of the device. Patients and relatives, however, were less concerned. We therefore began a prospective observational study to investigate using BIS in practice. Objective: To systematically explore recruitment to a study using BIS with hospice inpatients. Methods: We documented recruitment of all current inpatients and new admissions to the hospice electronically, logging patients‘ eligibility for the study and whether they had: i) been approached by clinicians, ii) agreed to see the researcher, and iii) consented to take part. Reasons for non-approach/non-participation were recorded at each stage. Results: A total of 313 patients were screened for inclusion; 142/313 (45%) were ineligible, mainly due to lack of capacity (59/142; 42%) or being too unwell (59/142; 42%). Clinicians approached almost all eligible patients (156/171; 91%); most of those were then seen by the researcher (137/156; 88%). For BIS monitor-related reasons (either restriction of movement or possible discomfort of sensor strip), one patient refused to see the researcher, and five of those who did (5/137; 4%) did not consent. Overall, 38/137 (28%) of those approached by the researcher participated (38/313 (12%) of all screened patients), while 75/137 (55%) refused, due mostly to experiencing distressing pain and/or fatigue (41/137; 30%). Conclusions: Potential participants in our study were mostly undeterred by the BIS device itself. The main recruitment challenges, similarly to other palliative care studies, were related to the nature of the patient population, but not to ‟gatekeeping” by clinical staff. Funding: Marie Curie I-CAN-CARE programme grant (ref: MCCC-FPO-16-U).