Delivering an implementation intervention to healthcare professionals, aimed at providing an intensive/supportive package of care when setting up non-invasive ventilation (including using telemonitoring), for people with motor neuron disease
Non-invasive ventilation in motor neuron disease
The DENIM Trial is an implementation hybrid trial, testing a theory-based implementation strategy aimed at improving the delivery of non-invasive ventilation (NIV) to people with motor neuron disease (MND). DENIM will be a multicentre study involving respiratory teams from different hospitals who are involved in the setup of NIV for people with MND. As well as testing the effectiveness of the theory-based intervention—a new intensive NIV initiation service (telemonitoring, education package, additional patient support, etc.)—DENIM is interested in understanding the process of implementation and how to better include people from underrepresented backgrounds in MND research. The main trial is a stepped-wedge, cluster randomisation controlled trial design. In practice, this means that 12 hospitals will join the study and all hospitals will recruit people with MND (who require NIV to be set up) to the control arm. The control arm participants will receive the usual care that their hospital provides for NIV setup and support. Hospitals will be put in groups of two (clusters). Every three months, a cluster (group of two hospitals) will be randomly assigned to switch to the intervention arm. The intervention arm will involve the healthcare professionals receiving a training package and other implementation elements such as identifying 'champions', attending educational meetings, identifying barriers and strategies specific to their hospital through surveys and observations. Hospitals will also be provided with telemonitoring capabilities and training. From this point onwards, all participants recruited by the hospital will be considered in the intervention arm, because these patients will receive a more intensive level of support from their respiratory team. Hospitals that remain in the control arm will continue to recruit participants to the control arm until they are randomly allocated to switch to the intervention arm. The reason for the cluster-stepped wedge desig
Trial participant inclusion criteria: 1. Patients aged 18 years or over 2. Have a diagnosis of MND confirmed by a consultant neurologist 3. With a clinical diagnosis of respiratory insufficiency according to local protocols, published guidelines and/or specialist opinion 4. Respiratory insufficiency judged by the treating clinician to be severe enough to warrant long term domiciliary NIV and requiring NIV optimisation within the duration of the study (12 weeks) 5. NIV initiated at home, in an outpatient setting or in hospital if hospital stay is less than or equal to 3 days post NIV initiation 6. Able to provide informed consent. Adults agreeing to try NIV and able to provide assent (evidence of agreement to take part in the study) but unable to provide informed consent will be able to participate if a consultee (close relative, informal carer, immediate care team) provides a consultee declaration Process evaluation patient interviews inclusion criteria: 1. Have consented to participate in DENIM 2. Are in the intervention arm 3. Are able and willing to participate in interviews (various options for facilitation available) and/or ethnographic observations 4. If relevant, are willing to share their preferred language for participation with the research team, to allow an appropriate researcher to be identified. Process evaluation family/carer inclusion criteria: 5. Relative/friend has consented to participate in DENIM 6. Are able and willing to participate in interviews and/or ethnographic observations Process evaluation staff interview inclusion criteria: 7. Direct contact with at least one patient who is participating in DENIM 8. Are able and willing to participate in interviews and/or ethnographic observations ACCESS sub study inclusion criteria: 1. From an ethnic minority and/or where the patient’s main language is not English 2. Or with low levels of digital health literacy (either those identified by the site teams or those scoring < 7 on the 3-Item Measur
1. Already initiated on NIV/CPAP for MND or another reason 2. Using tracheostomy ventilation 3. No way to connect the ventilation software to the internet whilst in the community 4. Patients not requiring optimisation within 12 weeks (e.g. those given the machine but are unable to commence NIV due to lack of social care).