Home monitoring and self-management for adult patients with cystic fibrosis during the novel coronavirus pandemic: a service evaluation in a specialist cystic fibrosis unit

Introduction

In January 2020 the novel COVID-19 was detected in the U.K. The World Health Organisation declared a pandemic on 11th March. By 15th March there were over 1000 U.K. cases, and high-risk groups, including those with cystic fibrosis (CF), were advised to ‘shield’; to remain inside to reduce infection risk (1). Telephone clinics replaced outpatient CF clinics; thus, lung function and weight were not being assessed. Clinic visits usually occur quarterly and are used to identify and treat pulmonary exacerbations. These cause long-term deterioration in lung function and poorer quality of life (2, 3) Our centre wanted to remotely monitor our highest risk patients and encourage them to recognise deterioration to help maintain the health of this vulnerable population.

Previous research in 267 patients with CF found that home monitoring significantly reduced the number of patients requiring intravenous (IV) antibiotics; 32% versus 52% in the control group, p = 0.027) and significantly reduced the number of hospitalisations (p = 0.015). Participants’ lung function was not negatively impacted (4) indicating that introducing home monitoring for our patients, potentially, could be safe and beneficial.

The Air Next by NuvoAir is a portable spirometer with disposable turbines that does not require calibration. It links to smart phones via Bluetooth® and results are automatically uploaded to a website that can be viewed from the CF clinic. The validity of the Air Next spirometer has been assessed and a Pearson correlation coefficient of greater than 0.94 for both FEV1 and forced vital capacity (FVC) has been demonstrated (5).

Weekly home monitoring of weight, symptoms and lung function may allow patients to remain at home, identify deterioration earlier and prevent decline in lung function. Patients with the greatest utilisation of healthcare in the preceding 12 months at our centre were chosen to trial home monitoring because they were at greatest risk of clinical deterioration. Funding had been secured for 16 spirometers and weighing scales through a hospital ‘change challenge’ initiative.

To support the use of home monitoring written, personalised action plans (PAPs) were utilised. PAPs are written guidelines providing individualised self-management instructions. There have not been any studies looking into the use of action plans for patients with CF but are recommended by national guidelines for use by patients with asthma to help maintain control of their symptoms (6). A Cochrane review in asthma found a statistically significant improvement in quality of life and a reduction in days lost from work or study (7).

This report outlines the set-up, patient satisfaction and initial adherence with home monitoring. It also reports on healthcare utilisation at our centre four months before and after the introduction of the devices and lung function data at the start and four months into the home monitoring project. Use and patient satisfaction with the PAPs, termed a traffic light system, was also reported.

Methods

This service evaluation was registered with the research and development team at our hospital. They reviewed the project in September 2021, once they had reopened after COVID-19, and confirmed that it was a service evaluation and therefore ethical approval was not required.

Adults with CF who had >28 days of IV antibiotics over the previous year were offered the equipment. All patients who agreed, received the home monitoring kit, consisting of an Air Next spirometer (NuvoAir, Stockholm, Sweden) and a set of weighing scales (Seca 875, Birmingham, England).

The devices were distributed to patients during appointments, collected by the patients or by their relatives. Patients set up their device independently using emailed instructions. They measured their weight and spirometry and completed a four-item symptom questionnaire on the NuvoAir application (app) weekly. In the questionnaire the patient uses a five-point scale to score each of the respiratory symptoms of breathing, cough, mucous and chest congestion.

When the patient was stable, baseline measures were used by the specialist Physiotherapists to develop a PAP detailing the action needed if their health deteriorated (Appendix 1). This was named a traffic light system and was emailed to the patient. When the patient’s lung function was stable, they were in the ‘green’ and no change in management was needed. A patient would score ‘amber’ if their lung function reduced between 5% and 10% of their symptom score and increased by one point and they had details on how to increase nebulisers and physiotherapy treatment and were advised to repeat lung function in three days. If their lung function dropped more than 10%, or their symptom score increased more than two points, then a red light was triggered. Patients were asked to contact the unit that day and further increase their nebulisers and physiotherapy.

Adherence was assessed by calculating the dates that weekly tests were expected and comparing them to the actual test dates from setup until 10th June 2020. Percentage adherence was then calculated. An adherence target of 80% was decided as an acceptable value as this would allow for a few, expected weeks where patients were unable to complete measurements. It also mirrors the adherence target set by Lechtzin and colleagues in 2017. If patients had not competed either spirometry of symptom measurements in the preceding two weeks, then a reminder text message was sent.

The number of courses and days of IV antibiotics each patient received for 4 months before and after receiving their spirometer were assessed retrospectively from patient records. Lung function data was taken at initial set up and four months after setup on the Nuvoair and included FEV1 and forced vital capacity (FVC). The measurement completed closest to the four-month date was used if the patient did not have a reading on the exact date. A mean value for FEV1 and FVC was calculated between all patients and compared before and after the monitoring period.

Patients’ experience of the Air Next spirometer, the app and the traffic light system were assessed using a questionnaire in SurveyMonkey®. (Appendix 2) All 16 patients were sent an email link inviting them to complete it and a follow-up reminder text if they did not respond initially.

Results

22 patients were eligible but four were unable to collect the equipment, one declined for mental health reasons, and one declined without reason. 16 patients agreed to participate. Funding for the equipment was agreed on 13th March. The equipment was set up between 4th April and 11th May 2020. Half the devices were collected by the patient themselves (8/16). Three of the patients (19%) were on home IV antibiotics when they started monitoring at home. One of the patients went on to be admitted to hospital.

Adherence

Of the 16 patients, only six (38%) carried out the expected number of tests in the monitoring period (Figure 1).

Green = >80% adherence.

Blue = <80% adherence.

Figure 1: Adherence to weekly monitoring.

Lung function

Over the four-month period FEV1 and FVC remained stable.

Figure 2: Lung function before and after home monitoring.

Antibiotic usage

Oral antibiotic usage reduced: 10 out of 16 (63%) patients had oral antibiotics compared with 14 patients (88%) before home monitoring. The average number of courses of oral antibiotics per patient also reduced from 1.6 prior to 0.8 after the home monitoring project.

The number of patients receiving IV antibiotics after the home monitoring project also reduced; 10 out of 16 (63%) patients had IV antibiotics before the project compared with only eight patients (50%) after (Figure 3). However, the average number of days of IV antibiotic was higher after the introduction of home monitoring (14.3 days before versus 14.6 days after).

Figure 3: Number of patients requiring IV or per oral (PO) antibiotics before and after home monitoring.

Patient experience

Eleven out of 16 patients (69%) completed the survey. Nine of the 11 (81%) patients found it ‘easy’ or ‘very easy’ to setup and use the spirometer. One patient found it difficult because they found it difficult to pair to their phone.

All patients (11/11, 100%) found it useful to monitor their spirometry at home with 6/11 (55%) finding it ‘extremely useful’, 3/11 (27%) ‘very useful’ and 2/11 (18%) ‘somewhat useful’.

An open question at the end allowed patients to comment on benefits and difficulties. (Tables 1 and 2).

Table 1: Patient reported benefits of the Air Next spirometer and app.

Table 2: Reported difficulties with the Air Next Spirometer and app.

Traffic light systems were received by 8 patients. Of these, 6 (75%) found it useful and easy to use. The other 2/8 (18%) found it ‘neither easy nor difficult’. 4 patients (4/8, 50%) used it to make changes to their treatment. See Appendix 3 for more details of the survey results.

Discussion

This report details the setup and evaluation of a home monitoring service for adults with CF. Initial results were promising, with a reduction in oral and IV antibiotics, stable lung function and overall satisfaction with the service. The sample size in this report is small and therefore care needs to be taken when widening the use of home monitoring to the rest of our clinic patients. However, the patients chosen were the higher risk patients, therefore we have confidence to expand the service to include those in lower risk groups as well.

Only 73% of patients approached to participate in this service evaluation agreed to home monitoring, which was lower than expected. The main reason was an inability to collect the equipment. It was decided not to post the kits out due to the risk of patients not receiving the equipment. Adherence to weekly monitoring was also found to be low although all patients did monitor less frequently. Previous research found 50% adherence to weekly spirometry (4) but low patient numbers at our centre may explain the discrepancy.

The reason that data analysis was carried out at four months was because a new genetic modifier drug, Kaftrio, was started on a large proportion of the patients at the beginning of September. This drug has shown to reduce exacerbation rate by 63% (8). Therefore, any data collected after this time may have been affected by this.

The reduction in the number of patients requiring antibiotics was positive (Figure 3). However, patients were also ‘shielding’, so less exposed to respiratory infections. The patients who did require IV antibiotics demonstrated a small increase in the number of days that they required. This may be an effect of closer monitoring detecting changes earlier than their clinical presentation would. One patient was on IV antibiotics for an unusually high number of days, causing an anomaly in the data. However, removing the influence of their data reduced the number of days on IV antibiotics from 12.3 days to 9.1 days. Lechzin et al (4) also found an increased number of pulmonary exacerbations and a shorter time to first exacerbation. However, they found that patients were more likely to have oral antibiotics, rather than IV antibiotics. This was in contrast with our results. This may be because patients at our clinic, before home monitoring, would have started a ‘rescue pack’ of oral antibiotics if they were not feeling well, without contacting the clinic. Since the introduction of home monitoring, they would have been reviewed by the CF team if their lung function had reduced as well as reporting symptoms.

One of the limitations was that the symptom questionnaire used was not validated. The use of the CF Respiratory Symptom Diary (CFRSD) was considered, (9). However, there is a cost associated with its use and compliance would likely below. There was poor adherence completing the in-app measure, despite regular prompts to complete it through text message.

The traffic light systems were developed to increase independence. However, only eight out of 15 patients reported receiving them via email. This has highlighted a need to follow-up with patients to ensure that they have received the information. Only 50% of patients reported making changes to their treatments based on their traffic light system. The reason for the low usage is not clear: one patient did comment that they are used to assessing their own health requirements therefore did not find it beneficial. Others may have had stable lung function, therefore had no need to make changes to their treatment.

For support in rolling out the use of home monitoring wider, our unit has since received funding and has purchased 80 extra kits. Results are reviewed weekly and those triggering an amber or red light are discussed at the multi-disciplinary team meeting and outcomes documented. Self-management will also be encouraged by ensuring that patients have received their traffic light system and clinicians are regularly prompting patients to use them.

Conclusion

The response to the introduction of a home monitoring service was positive and patients that participated have found it beneficial. Antibiotic usage was reduced, and lung function was maintained, indicating that it may have helped counteract the detrimental effects of a reduction in face-to-face appointments. This service evaluation has shown that it is safe to expand the service to more patients and will help to monitor the effects of the new medication, Kaftrio.

Key points

• Home monitoring was well received by our patients and all patients found it useful.

• Antibiotic usage reduced in the study period, but lung function remained stable.

• Patients found the self-management plans useful, and half the patients used them to make changed to their treatments in the study period, when previously they may have called the unit for advice.

1 GOV U.K. COVID-19: guidance on protecting people defined on medical grounds as extremely vulnerable. https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19 [Accessed 28th November 2022].

2 Sanders DB, Bittner RC, Rosenfeld M, Redding GJ, Goss CH. Pulmonary exacerbations are associated with subsequent FEV1 decline in both adults and children with cystic fibrosis. Pediatr Pulmonol. 2011;46(4):393–400. https://doi.org/10.1002/ppul.21374.

3 Britto MT, Kotagal UR, Hornung RW, Atherton HD, Tsevat J, Wilmott RW. Impact of recent pulmonary exacerbations on quality of life in patients with cystic fibrosis. Chest. 2002;121(1):64–72. https://doi.org/10.1378/chest.121.1.64.

4 Lechtzin N, Mayer-Hamblett N, West N, Allgood S, Wilhelm E, Khan U, Aitken M, Ramsey B, Boyle M, Mogayzel P, Gibson R, Orenstein D, Milla C, Clancy J, Antony V, Goss C; eICE Study Team. Home monitoring of patients with cystic fibrosis to identify and treat acute pulmonary exacerbations. eICE Study Results. Am J Respir Crit Care Med. 2017;196(9):1144–1151. https://doi.org/10.1164/rccm.201610-2172oc.

5 Lechtzin N, Mayer-Hamblett N, West N, Allgood S, Ellen Wilhelm E, Umer Khan U, Aitken M, Ramsey B, Boyle M, Mogayzel P, Gibson R, Orenstein D, Milla C, Clancy J, Antony V, Christopher H. Validation of the portable Bluetooth® Air Next spirometer in patients with different respiratory diseases. Respir Res. 2020;21(1):79. Published 2020 Apr 6. https://doi.org/10.1186/s12931-020-01341-z.

6 British Thoracic Society/Scottish Intercollegiate Guidelines Network. British guidelines on the management of asthma. A national clinical guideline. 2019. https://www.brit-thoracic.org.uk/news/2019/btssign-british-guideline-on-the-management-of-asthma-2019/ [Accessed 28th November 2022].

7 Gatheral T, Rushton A, Evans D, Mulvaney C, Halcovitch N, Whiteley G, Eccles F, Spencer S. Personalised asthma action plans for adults with asthma. Cochrane Database Syst Rev. 2017;4(4):CD011859. Published 2017 Apr 10. https://doi.org/10.1002/14651858.cd011859.pub2.

8 Middleton P, Mall M, Drevínek P, Lands L, McKone E, Polineni D, Ramsey B, Taylor-Cousar J, Tullis E, Vermeulen F, Marigowda G, McKee C, Moskowitz S, Nair N, Savage J, Simard C, Tian S, Waltz D, Xuan F, Rowe S, Jain R. Elexacaftor-tezacaftor-ivacaftor for cystic fibrosis with a single Phe508del Allele. N Engl J Med. 2019;381(19):1809–1819. https://doi.org/10.1056/nejmoa1908639.

9 Goss CH, Edwards TC, Ramsey BW, Aitken ML, Patrick DL. Patient-reported respiratory symptoms in cystic fibrosis. J Cyst Fibros. 2009;8(4):245–252. https://doi.org/10.1016/j.jcf.2009.04.003.