An Implementation Protocol for Noninvasive Ventilation Prescription: The Physiotherapist's Role in an Italian Hospital

Discussion

Our study showed that NIV or CPAP adaptation and its organizational procedures can be managed by a PT trained in respiratory care. Each new subject adapted to NIV requires < 3 hours of PT time (about 20 min/session) to be discharged with mechanical ventilation. The introduction of the PT profession in the NIV adaptation procedures and educational activities saves time for other health professionals.

The clinical practice of European PTs, in particular in the field of protocols and interventions, is emerging.¹³ Protocols are based on consensus, standardized care plan, and flow charts, according to objective measurable variables to allocate a performance and to reduce the time to be spent on it.^17,18 Protocols are used as a strategy to lower the occurrence of medical errors, omissions, and delays.^17,18 Protocols may reduce conflicts between team members, improve outcomes, decrease costs, and increase educational efforts.^17,18 The development of protocols and guidelines for NIV/CPAP management is recommended in order to clarify the roles of each professional¹⁹ and to increase greater efficiency during NIV application.²⁰

To our knowledge, no data from Italy are available on the PT's role in NIV/CPAP management. This lack may be due to differences in training courses offered to PTs, or to differences in hospital and health service organizations, compared to other countries. However, in Italy, in some acute units and rehabilitative institutes such as ours, PTs must develop skills that fall outside their traditional role, becoming involved in more specialized areas such as mechanical ventilation administration or sleep related disorder care.

Our study is consistent with existing literature regarding the role of each professional in the NIV management multidisciplinary team. Previous studies have pointed out that the role of the RT is mainly concentrated on ventilator and mask choice, the ventilator setup and the patient educational sessions,^19–22 while the physician's role is mainly related to NIV indication.²⁰ The nursing staff is usually identified as responsible for nocturnal monitoring and for catching problems and side effects such as facial skin damage.^22,23 The PT has been chosen for skills in terms of scientific background, competence in NIV and cough-assist techniques, and educational attitude. After the application of this new NIV/CPAP management procedure, all subjects completed NIV adaptation with a good level of adherence and comfort.

During the entire study, no clinical situations directly related to PT care were recorded, and there was no increase in time expenditure for NIV adaptation. The effect of the introduction of RTs in NIV management teams has been examined in only one study, by Kareus et al.²⁴ These authors demonstrated an improvement in NIV tolerance after RT involvement, increasing patient tolerance to NIV by about 51%. These data are in keeping with our results, since we found only one case of rejection of the proposed treatment. Results from 2 studies^12,20 are in keeping with the finding that for NIV poor adherence is a major issue, which may have been compounded by the lack of medical and non-medical staff training and the absence of an RT. The availability of sufficient PTs, the presence of experienced staff, and the frequent NIV use in our department have undoubtedly facilitated the implementation of our NIV/CPAP procedures.

The majority of our subjects were treated as in-patients (77.6%): the reason for this depended on the severity of disease in our subjects and the rehabilitative mission of our hospital, which admits patients, not only to adapt to NIV, but also for stabilization after an acute relapse or hospitalization. In-patients receive multidisciplinary evaluation, education, drugs stabilization, effort training, muscle reconditioning, nutritional assessment, and attention to social problems. Other factors are difficult discharge, rural geographical location and difficulty in reaching a hospital, and local health organizational reimbursement. Out-patient setting was proposed in 22.4% of the subjects, according to stability of the subject and subject consent.

An important finding from our study, relates to the time consumption by the PT. There is lack of consensus on time spent on adaptation activities. Chatwin et al¹⁶ reported a mean of 4 days (range 2–7 d) for the adaptation of in-patients with chronic restrictive disease, with a time-consumption of 2.85 hours per day. Unlike our results, a review of the study by Leger et al,¹⁰ which included chronic patients, reported that, when necessary, a mean of 3–4 hospitalization days to complete the long-term NIV adaptation process was mandatory. Both studies are divergent with our findings, and the differences could be explained by the holistic rehabilitative approach used by our department and the different clinical characteristics of our subjects. Our subjects were stable and non-critical, but highly complex, elderly, and had comorbidities, including bulbar muscle weakness or dysphagia, disability for several years, and long history of frequent exacerbations and ICU admissions.

Our data are in keeping with findings from Lujan et al.²⁵ Their prospective observational study investigated a population of chronic patients (neuromuscular, restrictive disease or COPD, not OSAS) similar to half of our subject group. These authors verified efficacy and efficiency of an NIV adaptation protocol conducted in about 5.5 out-patient sessions, compared to the usual average hospital adaptation time of 7 days.²⁵

Moreover, an interesting aspect of our work is that the ALS/neuromuscular subjects required more time during adaptation and education, compared to those with OSAS and pulmonary restrictive disease. This is not surprising, since ALS/neuromuscular was the subgroup with the higher adaptation efforts due to their clinical complexity and dependence involving caregivers at discharge. We should also emphasize that mean time spent by the PT during the subject's entire hospitalization to complete the NIV or CPAP adaptation was less than 3 hours, distributed over a mean of 8 sessions. Our setting differs from clinical practice guidelines in that, after a decision to start, the protocol prescribes a specific series of behaviors or changes in treatment, without the requirement of further clinician input.¹⁸ Although we lack specific data on the PTs' time-efficiency during the time course of the protocol, we have noted a learning effect due to higher experience and training, as demonstrated by the decrease in the physicians' face to face visits, second opinion telephone calls, and inappropriate choice of devices, during the last months of the protocol application, compared to the starting months.

The introduction of a PT in the process/management of NIV/CPAP adaptation resulted in a decrease of time-consumption for other health professionals dedicated to the same protocol. In particular, pulmonologists decreased their time dedicated to activities such as ventilation management by 65%, and nurses by 35%. The consequent cost saving and/or economic rationalization in NIV/CPAP management could be very important for overall health care reimbursements. In order to verify cost/benefit outcomes, these data must be confirmed by large detailed studies.

From our data it must be stressed that PTs are not presented as an alternative to nurse and pulmonologist involvement, but, instead, they are complementary and synergic. Addition of a further professional to the team may optimize delivery of service

Another important key point is that our data were obtained from a single hospital in Italy. Similar outcomes might not be seen in other hospitals and in other countries. For example, in hospitals in North America, RTs are trained to initiate and monitor NIV. In countries or hospitals where RTs are not available, our protocol might be useful to consider. However, specialized training must be introduced to PTs who are being considered for such role. The lack of comparison with historical data or among different populations or among different health professionals is an important limitation of the study. Another major limitation in our work is related to the lack of long-term NIV/CPAP adherence outcomes. Our results would be more meaningful if comparative data with a randomized study or retrospective data prior to PT involvement would have been available. Another limitation is that we cannot gauge how much the implementation of our protocol per se improved care efficiency.