None listed
Conditions
Brief summary
In people with Cystic Fibrosis (CF) those who have higher numbers of lung (pulmonary) exacerbations (increased cough, sputum, shortness of breath) live shorter lives than those who have fewer exacerbations. We think that a delay in managing lung exacerbations can lead to worse results. In the past two years more people with CF have been interested in digital ways of getting CF healthcare. The COVID-19 pandemic meant more people got healthcare at home or in the local community rather than in hospitals. People with CF have said they want this to continue post pandemic. This research study will look at new ways of providing care for people with CF using an online system, which is connected to our hospital medical record, that can pick up lung exacerbations in people with CF by examining symptoms (cough, sputum, breathing) that they enter into the system. If the system identifies a lung exacerbation, it will send out an action plan to the person with CF, explaining what they can do to help them get better from their lung exacerbation. The research study will run for 12 months and will compare the online detection system to normal CF care to understand if the new system is easy to use, liked and supported for ongoing use by people with CF and the CF team compared to the current system.
Interventions
Rationale and background:
We are interested in investigating the feasibility, acceptability and effect of a new remote symptom monitoring an automated treatment plan model of care in children with Cystic Fibrosis (CF) on highly effective modulators. There is current evidence pointing to the feasibility of remote symptom monitoring in people with CF, however all were performed prior to widespread access to highly effective modulators and all required the involvement of the CF multidisciplinary t
Rationale and background: We are interested in investigating the feasibility, acceptability and effect of a new remote symptom monitoring an automated treatment plan model of care in children with Cystic Fibrosis (CF) on highly effective modulators. There is current evidence pointing to the feasibility of remote symptom monitoring in people with CF, however all were performed prior to widespread access to highly effective modulators and all required the involvement of the CF multidisciplinary team (MDT) to direct treatment recommendations. This study will generate new evidence relating to the use of remote symptom monitoring and automated treatment plans in children with CF on highly effective modulators. Trial design: This will be a pilot randomised, non-blinded, single center trial in children with CF attending the Royal Children’s Hospital (RCH) on highly effective modulators. The study will compare usual care (control arm) to an intervention arm, with the intervention being the new remote symptom monitoring and automated treatment plan model of care. The new model of care will be housed in the electronic medical record (EMR) used by RCH. The trial will use the Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS), a validated tool for detecting pulmonary exacerbations in people with CF for the symptom monitoring. Description of intervention: Participants randomised to the intervention arm will receive onboarding material detailing instructions of how to access and use the remote monitoring system via the RCH portal. Participants will be asked to complete the CFRSD-CRISS in two ways: 1. Baseline symptom survey (copy of CFRSD-CRISS can be found in supporting documents - "Baseline and symptom survey") (3 minutes to complete) Participants will be prompted to complete survey by a push notification sent to their mobile phone and built into the EMR at the: o Commencement of the trial; o Each month post commencement of the trial; and o After each exacerbation is detected. 2. Twice weekly symptom survey (copy of CFRSD-CRISS can be found in supporting documents - "Baseline and symptom survey") (3 minutes to complete) Participants will be prompted to complete a survey by a push notification sent to their mobile phone and built into EMR twice a week. Monitoring of survey completion will occur by running reports through the EMR. As this pilot is assessing feasibility limited prompting of families to complete surveys will occur. A score is assigned to each survey field. Every symptom-monitoring questionnaire completed by the patient or patient’s family is compared to their last known baseline questionnaire. If the frequency or severity of two or more symptoms have worsened compared to baseline, the Exacerbation Pathway is triggered. If the system detects an exacerbation, it will send an automated treatment plan out to the patient and their caregiver including: • Directions to commence a specific antibiotic • Directions to change/or increase airway clearance and inhalation therapy. Information regarding antibiotic, airway clearance and inhalation therapy prescription will be extracted from the participant’s EMR file. At this time participants will be asked to complete their symptom survey on a daily basis. A message will be sent to the CF team alerting them of the exacerbation and the results of the symptoms survey. The RCH respiratory lab will book a telehealth appointment to perform home lung function to provide further detail of the exacerbation. Lung function will be performed at the start of the exacerbation and at 10-14 days later. 10-14 days after the exacerbation pathway is triggered, the program will assess if symptoms reported in the daily symptom survey have returned to baseline or not. If the patient symptoms return to (or are better than baseline) on day 10-14: 1. The program re-assigns the non-exacerbation tasks: a. Monthly baseline questionnaire b. Symptom-monitoring questionnaire (twice a week). 2. An automated In Basket message will be sent to the CF team notifying them that the exacerbation has ceased. 3. An automated message is sent to notify the participant that symptoms have improved and the exacerbation has ceased, instructing them to cease antibiotics (if not already), return to baseline airway clearance and inhalation therapy and complete their normal twice weekly symptom surveys. If the patient symptoms do not improve on day 10-14 (Extended Exacerbation): 1. A message will be sent to the CF team prompting for a clinical review via telehealth. 2. A notification will be sent to the participant via the portal notifying them that their symptoms have not become better and expect contact from the treating team in 24 hours. The RCH EMR team have designed a workflow for the pilot to help assist in ensuring all aspects of care are completed. Participants randomised to the intervention group will also receive all aspects of usual care in addition to the above information, including quarterly visits to the CF clinic. Trial delivery and staff: The intervention will be monitored by an experienced team including CF clinicians all with > 5 years specific CF experience (medical, nursing, physiotherapists and respiratory physiologists) alongside the RCH EMR and digital health team. One of the aims of the new model of care is to decrease the burden of care of visiting the hospital in person, therefore the majority of clinical reviews and lung function testing will occur via telehealth (which is standard practice for the CF team). Trial duration: The trial will run for a 12 month period.
Sponsors
Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosis of Cystic Fibrosis - On a highly effective modulator (either ivacaftor or elexacaftor–tezacaftor–ivacaftor for a minimum of 2 weeks) - Clinically stable without antibiotic treatment for a pulmonary exacerbation in 2 weeks prior to consent - Attending RCH CF clinic - Able to complete home spirometry (standard of care for all children with CF >5 years at RCH CF clinic) - Sufficient English to complete a survey - Access to a smart phone to access remote symptom monitoring surveys
Exclusion criteria
- Participants not signed up or not willing to sign up to the RCH Portal (note that 80% of RCH CF patients are already signed up to the portal) - Participants who do not have access to a smartphone or computer on a daily basis - Participants who do not have access to a home spirometer for lung function purposes - Participants will be excluded from the study for technological access reasons such as lack of access to the RCH Portal and IT equipment as this is the basis of the intervention.
Outcome results
None listed