Respiratory

SMA's for COPD in Primary Care (New) - IRAS: 315909

Recruitment end date: September 2023 for getting PCN/GP practices onbaord November 2023 for participant recruitment

Aim: This study is trying to find better ways to help people manage their COPD

themselves. To support patients, some general practices are trying shared medical appointments (SMAs),also known as group consultations, where a group of 6-8 patients, with the same condition, share a longer appointment lasting about 60 -90 minutes. Patients can ask staff questions and share their experiences with others in the group. We do not know how well SMAs work for patients with COPD or whether it is more costly than usual care. Recently, more care is being delivered by video, but we do not know if this is possible in groups of patients. This research will test these shared medical appointments in a small study to help decide if a larger trial is possible in the future. This study aims to recruit 6-8 GP practices that will work with other practices within their primary care networks (PCNs) to deliver the SMA. Practices will support the recruitment of 132 patients with COPD. These patients will be randomly allocated to attend  shared appointment either in-person, by video link, or receive usual care.

Requirements:

• Work together with other practices within their primary care network to deliver the intervention (a shared medical appointment, either in-person or by video link). This will involve pooling patients and staff (interventionists) across practices within the same PCN.

• Run a search of patient records (using search terms provided) to identify potential participants.

• GP to screen list against eligibility criteria.

• Admin staff to send text messages to potential participants informing them of the study.

• Where text messaging services are unavailable, administrators to ring potential participants to introduce the study and ask the participant for verbal consent to pass their details onto the study team for further information about the study. Or Nurse/pharmacists introduces study to potential participants during  annual review appointment and obtains verbal consent to pass contact details to the study team.  

•  Primary care networks to provide staff to form two teams of pharmacists/nurse practitioner, healthcare assistant and social prescriberThese teams will attend training and deliver the intervention across the PCN practices.

• If hosting in-person SMAs, provide space to hold a 60-90 minute SMA for up to 8 patients.

Payments: 

Service support costs: Database search x3 every 2 months :- Practice Manager £104.45

Check list for exclusion :- GP  £59.40 per 200

Research Costs: Local coordination & study set up meeting :- Practice Manager  £46.42 &  GP  £180

• Study information text message

•  Opportunistic invitation at Annual Review appt and permission to contact  -Pharmacist £825 per 150 participants

•  Opportunistic invite (phone) and permission to contact - Admin £112.97 per 50 participants

•  Study participant randomisation & shared medical appointment letters -Admin  £7.89 per 18 participants

•  Data collection from patient records at 12 months - Practice Manager £71.02 per 18 participants

• Practice staff (interventionist) attend post- SMA interview -

                        -  Administrator- £13.29 per hr x2

                        -  Pharmacist/ Nurse Practitioner - £55.00 per hr x2

                        - Healthcare assistant - £11.53 per hr x2

                        -  GP - £90.00 per hr x2

• If hosting in-person SMA’s  Room Hire- 2 hrs 30 mins x 6 sessions £225.00

•  Resource use form completion - Practice manager £1.86

Excess Treatment Costs: £22.53 per participant 

https://www.youtube.com/watch?v=fbC5d6_X4rk 

RELIEF Trial IRAS: 1006098 CPMS:54357

Recruitment closes 31 March 2024

Aim:The overall aim is to determine the clinical and cost effectiveness of replacing Salbutamol inhalers with inhalers containing ICS/formoterol for symptom relief in patients with asthma treated with low dose ICS maintenance treatment. Our hypothesis is that using a combination of ICS/formoterol instead of Salbutamol for symptom relief will reduce asthma exacerbations because it provides more ICS when needed and overcomes the common problem of poor adherence with maintenance ICS treatment.

A qualitative sub-study will investigate the acceptability of the intervention.

We will be conducting a ‘study within a trial’ (SWAT), subject to a substantial amendment, to investigate the effects of an intervention package to improve inclusivity in the trial. 

Requirements: 

• Display posters/leaflets - Discuss study with patients expressing interest after seeing posters/leaflets

• Database search - GP to check list for eligibility - Mail out

• Consent/ baseline visit and randomisation

• Instruct patients on inhaler use

• For approximately 15% of all randomised patients, phone them following an exacerbation to conduct phone interview (if patient responds yes to text message only)

• At 6 and 12m review patient inhaler prescribing information

• Complete SAEs for patients who meet the criteria (expected to be very low for this group)

• Complete a 12m face to face visit including providing patient with questionnaires and collecting responses

• GP to oversee patient care and prescribe to patient

• Also SWAT (study within a trial) which will randomise practices to use of resources for non-English speakers (randomised by practice so not all will be included in the SWAT).

Payments: 

Service Support Costs 

• For preparation and database search: £10.50 fixed fee per practice

• GP to check list for exclusions: £36.00 fixed fee per practice

• Informed consent: £18.00 per patient

Research Costs

Maximum £300 per patient recruited and for whom all data is returned 

ETC 

Per-patient Excess Treatment Cost to be confirmed, subject to outcome of NIHR Coordinating Centre triage process. 

 OPACE (CPMS 55548)

Coming soon

Aims: to assess the outcome of discontinuing azithromycin prophylaxis in stable COPD patients 

Patients will be randomised to receive either:

1.Continuous azythromycin (usual care)

2.Seasonal discontinuation (matched placebo)

3.Complete discontinuation (placebo)

Requirements: 

• Database search, screen patient list and mail out/text out

• Participants to attend up to two face-to-face visits to the practice 

• Up to five telephone or remote follow up visits

• Assessments will mostly be questionnaire based 

• Research Nurse support available for visits

• HES and ONS data collected via NHS Digital (with consent)