CFHealthHub Data Observatory project

The Data Observatory project aims to build on the work of the CFHealthHub platform, using objective adherence data from 17 UK Cystic Fibrosis (CF) centres to help improve the care that people with CF (pwCF) receive at local and national level.

On

A quality improvement project and trials within cohort platform for cystic fibrosis

The Data Observatory project aims to build on the work of the CFHealthHub platform, using objective adherence data from 17 UK Cystic Fibrosis (CF) centres to help improve the care that people with CF (pwCF) receive at local and national level.

The project aims to do this in two ways:

First, adherence data collected using dose-counting nebulisers, will be shared with CF healthcare professionals via the CFHealthHub platform – this information can then be used within routine care encounters and within Quality Improvement projects to help shape the care delivered in CF centres in supporting pwCF to self-manage their treatments successfully;
Second, the ‘Trials within Cohorts’ (TwiCs) research database is intended to hold data for a large number of pwCF for future research studies, centred around behaviour change. This approach will help CF researchers to overcome the difficulties associated with conducting research in rare conditions such as high costs and poor recruitment. We have currently recruited 1300 patients, across 17 different UK CF centres to the CFHealthHub Data Observatory. The intention is to recruit up to 6,000 adults with CF to contribute objective adherence data to the CFHealthHub platform over 4 years.

Study staff

Name	Role	Organisation	Contact
Dr Martin Wildman	Chief Investigator	91̽�� Teaching Hospitals NHS Foundation Trust	martin.wildman3@nhs.net
Prof Cindy Cooper	CTRU Oversight	Clinical Trials Research Unit, University of 91̽��	c.l.cooper@sheffield.ac.uk
Liz Cross	Trial Manager	Clinical Trials Research Unit, University of 91̽��	e.a.cross@sheffield.ac.uk
India Davids	Research Assistant	Clinical Trials Research Unit, University of 91̽��	i.davids@sheffield.ac.uk
Emma Young	Research Assistant	Clinical Trials Research Unit, University of 91̽��	e.l.young@sheffield.ac.uk
Louise Turner	Trial Support Officer	Clinical Trials Research Unit, University of 91̽��	louise.turner@sheffield.ac.uk
Dr Pauline Whelan	m-Health Applications Manager	HeRC, University of Manchester	pauline.whelan@manchester.ac.uk
Steven Antrobus	Senior Technical Project Manager	HeRC, University of Manchester	steven.antrobus@manchester.ac.uk
Steve Harrison	Deputy Director of Organisational Development	91̽�� Teaching Hospitals NHS Foundation Trust	steve.harrison6@nhs.net
Caroline Eadson	Head of Quality Improvement & Leadership Development Organisational Development	91̽�� Teaching Hospitals NHS Foundation Trust	c.eadson@nhs.net
Misbah Tahir	EMBRACE Pharmacist	91̽�� Teaching Hospitals NHS Foundation Trust	misbah.tahir@nhs.net
Amanda Bevan	National Pharmacy Lead – CF Self-care CQUIN	Southampton University Hospitals NHS Foundations Trust	amanda.bevan@uhs.nhs.uk
Marlene Hutchings	Research Physiotherapist	91̽�� Teaching Hospitals NHS Foundation Trust	marlene.hutchings1@nhs.net
Prof Madelynne Arden	Professor of Health Psychology	91̽�� Hallam University	m.arden@shu.ac.uk
Sophie Dawson	CFHealthHub Interventionist and National Quality Improvement Lead	Nottingham University Hospitals NHS Trust	Sophie.Dawson@nuh.nhs.uk
Charlotte Carolan	CFHealthhub National Quality Programme Manager	91̽�� Teaching Hospitals NHS Foundation Trust	charlotte.carolan@nhs.net
Lisa Watson	Research Coordinator and CFHealthHub Trial Sponsor	91̽�� Teaching Hospitals NHS Foundation Trust	lisa.watson24@nhs.net

Participating sites

Site	Name	Role	Contact
91̽�� Teaching Hospitals NHS Foundation Trust	Dr Martin Wildman	Principal Investigator	martin.wildman3@nhs.net
91̽�� Teaching Hospitals NHS Foundation Trust	Michelle Lowther	Clinical Coordinator	michelle.lowther1@nhs.net
Nottingham University Hospitals NHS Trust	Dr Jane Dewar	Principal Investigator	Jane.Dewar@nuh.nhs.uk
Nottingham University Hospitals NHS Trust	Sophie Dawson	Interventionist	Sophie.Dawson@nuh.nhs.uk
University Hospital Southampton NHS Foundation Trust	Dr Mark Allenby	Principal Investigator	Mark.Allenby@uhs.nhs.uk
Frimley Health NHS Foundation Trust	Dr Chris Orchard	Principal Investigator	Christopher.Orchard@fhft.nhs.uk
Frimley Health NHS Foundation Trust	Josie Cunningham	Interventionist	josie.cunningham@nhs.net
The Newcastle upon Tyne Hospitals NHS Foundation Trust	Dr Stephen Bourke	Principal Investigator	stephen.bourke1@nhs.net
The Newcastle upon Tyne Hospitals NHS Foundation Trust	Alan Anderson	Interventionist	alan.anderson8@nhs.net
University Hospital of the North Midlands NHS Trust (Stoke)	Dr Giles Fitch	Principal Investigator	giles.fitch@uhnm.nhs.uk
Oxford University Hospitals NHS Foundation Trust	Dr William Flight	Principal Investigator	william.flight@ouh.nhs.uk
Oxford University Hospitals NHS Foundation Trust	Louise Warnock	Interventionist	louise.warnock@ouh.nhs.uk
Oxford University Hospitals NHS Foundation Trust	Tracy Barnett	Interventionist	Tracy.Barnett@ouh.nhs.uk
University Hospitals Bristol NHS Foundation Trust	Dr Kathryn Bateman	Principal Investigator	Kathryn.Bateman@uhbristol.nhs.uk
University Hospitals Bristol NHS Foundation Trust	Ashley Tugwell	Interventionist	Ashley.Tugwell@uhbw.nhs.uk
York Teaching Hospital NHS Foundation Trust	Dr Rebecca Thomas	Principal Investigator	Rebecca.Thomas@York.nhs.uk
Hull University Teaching Hospitals NHS Trust	Dr Dejene Shiferaw	Principal Investigator	Dejene.Shiferaw@hey.nhs.uk
Royal Devon and Exeter NHS Foundation Trust	Dr Nick Withers	Principal Investigator	nick.withers@nhs.net
University Hospital of Leicester NHS Trust	Dr Chandra Ohri	Principal Investigator	chandra.ohri@uhl-tr.nhs.uk
University Hospital of Leicester NHS Trust	Darren Tature	Interventionist	darren.tature@uhl-tr.nhs.uk
Norfolk and Norwich University Hospitals NHS Foundation Trust	Dr Mark Pasteur	Principal Investigator	mark.pasteur@nnuh.nhs.uk
University Hospitals Plymouth NHS Trust	Dr David Derry	Principal Investigator	david.derry@nhs.net
University Hospitals Plymouth NHS Trust	Dr David Waine	Principal Investigator	david.waine@nhs.net
University Hospitals Plymouth NHS Trust	Harriet Gledhill	Interventionist	harriet.gledhill@nhs.net
University Hospitals Plymouth NHS Trust	Michelle Thomas	Interventionist	michelle.thomas1@nhs.net
Royal Cornwall Hospitals NHS Trust	Dr Jonathan Myers	Principal Investigator	jonathanmyers@nhs.net
University Hospital Birmingham NHS Foundation Trust	Dr Joanna Whitehouse	Principal Investigator	Joanna.whitehouse@heartofengland.nhs.uk
University Hospital Birmingham NHS Foundation Trust	Jocelyn Choyce	Interventionist	jocelyn.choyce@heartofengland.nhs.uk
Blackpool Teaching Hospitals NHS Foundation Trust	Dr Saba	Principal Investigator	dr.saba@nhs.net
Blackpool Teaching Hospitals NHS Foundation Trust	Natasha Pickering	Interventionist	natasha.pickering@nhs.net
Blackpool Teaching Hospitals NHS Foundation Trust	Michael Dooney	Interventionist	michaeldooney@nhs.net
Lewisham and Greenwich NHS Foundation Trust	Lucy Baker	Principal Investigator	lucy.baker@nhs.net

CFHealthHub overview and background

The Data Observatory opened in 2017 in three UK Cystic Fibrosis (CF) Centres: 91̽��, Nottingham and Southampton. Between 2017 and 2020, the Data Observatory has expanded to include 17 CF centres out of 28 in the UK. Participating sites have recruited a total number of 1300 patients to the system. Using the learning from previous phases, the centres apply quality improvement cycles and behaviour change techniques, to integrate CFHealthHub as a resource accessible to all of the MDT. Most sites were able to access NHS England CQUIN funding (PSS CF self care CQUIN). The funding allowed each centre to have a dedicated Behaviour Change Interventionist to support patients and the clinical team. The CQUIN also provided a day a week pharmacist for 14 of the English NHS Trusts. This is currently supporting the EMBRACE work stream, exploring how CFHealthHub adherence data can be used for medicines optimisation.

During COVID19 we have changed some of our processes to allow CFHealthHub to be used as a tool for virtual care. To find out more, please see the protocol or contact the study manager.

The CFHealthHub Intervention

Participants who consent to take part in the study receive a new chipped nebuliser, or have their existing nebuliser adapted to communicate with CFHealthHub. They will be given a log in to the CFHealthHub system and shown how to use their device and the CFHealthHub website, by a member of their care team. This includes how to turn on and off data sharing with their clinical team. Participants will then be able to use their nebuliser as normal, with the support of CFHealthHub. CFHealthHub automatically collects data on the participants' use of their chipped nebuliser, specifically the time of use and duration of inhalation. The data is stored in the secure CFHealthHub server. The patients CFHH account uses answers to a behaviour change questionnaire based on the COM-B model to tailor the content provided on their CFHH account.

Additionally the CF team will be able to view the adherence data for participants who have data sharing switched on, and identify if any participants could benefit from the behavioural intervention that has been previously tested within the AC. The Data Observatory will not be measuring the effectiveness of this intervention. Instead, CFHealthHub will help facilitate quality improvement projects using data from CFHealthHub about participants adherence and participant's relationship with the team.

CFHealthHub Platform

CFHealthHub is an online portal which displays adherence data and provides behaviour change resources and tools for people with Cystic Fibrosis (PWCF), these tools used alongside trained CF health professionals support changes in patient self-management (nebuliser adherence). It is available on-line via computers, tablets or mobile phones. This agile platform acts as a software development collaborative, whereby patients and staff feedback to software developers at the University of Manchester to iteratively refine and improve CFHealthHub via monthly video conference calls.

Quality Improvement Work

The Data Observatory facilitates quality improvement projects, which act as an intervention within the CF team. These QI projects utilise the Clinical Microsystem methodology developed by the Dartmouth Institute, USA (Nelson, Batalden and Godfrey, 2007) and adopted by the 91̽�� Microsystem Coaching Academy (MCA). The 91̽�� MCA () approach advocates that complex health systems can be reduced to smaller building blocks called ‘microsystems’ where multidisciplinary teams deliver healthcare to patients. At each microsystem a number of QI projects may occur but the implementation requires the completion of four phases; Assessment, Diagnose, Treatment and Standardise, where tools such as assessment using the 5 P’s (Purpose, Patients, Professionals, Processes, Patterns) process mapping, time series measurements, Plan Do Study Act (PDSA) cycles are utilised until the change idea has been adapted or has become embedded into the microsystem.

Further information can be found by going to the .

EC Nelson, PB Batalden, MM Godfrey - A clinical microsystems approach, 200

Publications

2020

Journal Articles

Martin R, Arden M, Porritt J, Wildman M, Naughton F. Investigating the Temporal Relationships between Symptoms and Nebuliser Adherence in People with Cystic Fibrosis: A Series of N-of-1 Observations. Healthcare (Basel). 2020;8(1):22. Published 2020 Jan 21. doi:10.3390/healthcare8010022. Available .

2019

Journal Articles

Arden MA, Drabble S, O'Cathain A, Hutchings M, Wildman M. Adherence to medication in adults with Cystic Fibrosis: An investigation using objective adherence data and the Theoretical Domains Framework. Br J Health Psychol. 2019;24(2):357‐380. doi:10.1111/bjhp.12357. Available .

Drabble SJ, O’Cathain A, Arden MA, Hutchings M, Beever D, Wildman M. When Is Forgetting Not Forgetting? A Discursive Analysis of Differences in Forgetting Talk Between Adults With Cystic Fibrosis With Different Levels of Adherence to Nebulizer Treatments. Qual Health Res. 2019;29(14):2119-2131. doi:10.1177/1049732319856580. Available .

Gao J, Arden M, Hoo ZH, Wildman M. Understanding patient activation and adherence to nebuliser treatment in adults with cystic fibrosis: responses to the UK version of PAM-13 and a think aloud study. BMC Health Serv Res. 2019;19(1):420. Published 2019 Jun 24. doi:10.1186/s12913-019-4260-5. Available .

Hind D, Drabble SJ, Arden MA, et al. Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC Pulm Med. 2019;19(1):77. doi:10.1186/s12890-019-0834-6. Available .

Hoo ZH, Gardner B, Arden MA, et al. Role of habit in treatment adherence among adults with cystic fibrosis. Thorax. 2019;74(2):197‐199. doi:10.1136/thoraxjnl-2017-211453. Available .

Hoo ZH, Wildman MJ, Campbell MJ, Walters SJ, Gardner B. A pragmatic behavior-based habit index for adherence to nebulized treatments among adults with cystic fibrosis. Patient Prefer Adherence. 2019;13:283‐294. Published 2019 Feb 13. doi:10.2147/PPA.S186417 Available .

Protocols

Wildman M, Hutchings M, Arden M, O’Cathain A, Drabble S, Walters SJ, et al. Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis: A randomised controlled trial and parallel process evaluation protocol [Internet]. Online Research Data (ORDA). 2018 [cited 2019 Feb 21]. Available .

Conference Abstracts

C. Carolan, M. Lowther, C. Clarke, S. Waterhouse, C. Girling, K. Strowbridge, S. Harrison, F. Edenborough, C. Rachel, M. Wildman. (2019). ePS5.06 Quality improvement within a learning health system: using PDSA cycles to embed a digital behaviour change platform, CFHealthHub, in routine care. Journal of Cystic Fibrosis, 18(1), S52. ECFS 2019. Available .

C. Carolan, C. Clarke, M. Lowther, C. Girling, S. Harrison, F. Edenborough, R. Curley, M Wildman. (2019). P433 Supporting patients to move from rescue to prevention: meeting patients on their own terms - a preliminary evaluation of out of hours adherence telephone support offered to cystic fibrosis patients using the digital health system CFHealthhub. Journal of Cystic Fibrosis, 18(1), S179-S180. ECFS 2019. Available .

C. Clarke, C. Carolan, M. Lowther, S. Waterhouse, K. Strowbridge, S. Harrison, C. Girling, F. Edenborough, R. Curley, M. Wildman. (2019). P432 How physiotherapists improved prescription accuracy for nebuliser treatment: using click analytics from CFHealthHub, a digital adherence system, to monitor quality improvement. Journal of Cystic Fibrosis, 18(1), S179. ECFS 2019. Available .

Dawson, S., Haynes, F., Millward, S., Horton-Smith, C., Parr, L., Barr, H., Saini, G., & Dewar, J. (2019). Identifying the challenges involved in maintaining an accurate record of patient nebuliser prescriptions at a UK adult CF Centre: a quality improvement project. Journal of Cystic Fibrosis, 18(1), S177. ECFS 2019. Available .

Girling, C., Hind, D., Arden, M.A., & Wildman, M.J. (2019). Developing an implementation strategy for the use of objective adherence data in routine clinical practice: a case study in cystic fibrosis clinics. Implementation Science, 14(Supp 2), 4-5.

Girling, C., Totton, N., Hind, D., Wildman, MJ. (2019). CFHealthHub Data Observatory: A trials within cohort platform for habit formation in Cystic Fibrosis. Presented at Trials Using Cohorts and routine data: Efficacy and Analysis Symposium, 2019. London, United Kingdom.

Hoo, Z. H., et al., (2019). Understanding objective adherence to preventative inhaled therapies at a centre level for quality improvement - a CFHealthHub (CFHH) improvement collaborative study. Journal of Cystic Fibrosis, 18(1), S51-S52. ECFS 2019. Available

Whelan P, Stockton-Powdrell C, van Velsen L, Tabak M, Wolf K, Interdisciplinary Perspectives on Connected Health Research: Facilitators and Barriers for Sustainable Platform Development, MedInfo, Lyon, August 2019.

Communications

Arden M. (2019) Health and habits The Psychologist [Internet]. 2019 [cited 2019 Mar 4]. p. 07. Available .

2018

Journal Articles

Hoo ZH, Coates E, Maguire C, et al. Pragmatic criteria to define chronic pseudomonas aeruginosa infection among adults with cystic fibrosis. Eur J Clin Microbiol Infect Dis. 2018;37(11):2219‐2222. doi:10.1007/s10096-018-3358-8. Available .

Conference Abstracts

Arden, M.A., Gao, J. Hoo, Z.H, Wildman, M. The Patient Activation Measure and adherence in adults with Cystic Fibrosis: A think-aloud study. BPS Division of Health Psychology Annual Conference, Newcastle, UK, 5th-7th September 2018.

2017

Journal Articles

Tappenden P, Sadler S, Wildman M. (2017). An Early Health Economic Analysis of the Potential Cost Effectiveness of an Adherence Intervention to Improve Outcomes for Patients with Cystic Fibrosis. Pharmacoeconomics. 2017;35(6):647‐659. doi:10.1007/s40273-017-0500-x. Available .

Conference Abstracts

Arden M, Drabble S, O’Cathain A, Hind D, Hutchings M, Whelan P, et al. (2017). CFHealthHub: The development of a digital intervention to provide feedback on objective nebuliser adherence data for adults with Cystic Fibrosis (CF). Frontiers in Public Health, 3rd UCL Centre for Behaviour Change Digital Health Conference 2017: Harnessing Digital Technology for Behaviour Change. Available .

Arden MA, Hutchings M, Whelan P, Wildman MJ, CFHealthHub group. (2017). Understanding nebuliser adherence in adults with Cystic Fibrosis: comparing high, medium and low adherers. European Health Psychologist, 19(Supp). The European Health Psychologist 2017 Conference. Available .

Beever DA & Wildman M (2017). A personal reflection on being a co-applicant in the ACtiF study. Research Involvement and Engagement, 3(Supp 1). NIHR Involve Conference 2017. Available .

Hind D, Maguire C, Cantrill H, O’Cathain A, Wildman M. (2017). EPS2.8 CFHealthHub: complex intervention to support adherence to treatment in adults with cystic fibrosis: external pilot trial. Journal of Cystic Fibrosis, 16(1), S40-S41. ECFS 2017. Available .

Hoo ZH, Curley RE, Campbell SMJ, Wildman MJ. (2017). IPD2.09 Cluster analysis of objective nebuliser adherence data among adults with CF: change in adherence over time and association with clinical outcomes. Journal of Cystic Fibrosis, 16(1), S60-S61. ECFS 2017. Available .

Hoo ZH, Waterhouse S, Nightingale JA, Dewar J, Allenby M, Haynes F, et al. (2017). 155 CFHealthHub: using Leeds criteria and clinicians’ decision to determine the pseudomonas status among the 64 adults with cystic fibrosis in the two centre CFHealthHub (CFHH) pilot study. Journal of Cystic Fibrosis, 16(1), S105-S106. ECFS 2017. Available .

Horspool K, Whelan P, Wildman M. (2017). 367 CFHealthHub: iterative co-production of a data feedback platform providing patient level adherence data to multi-disciplinary teams to optimise individual care and centre level adherence data to centre directors allowing benchmarking to enable centre level quality improvement cycles in a 3 centre improvement collaborative. Journal of Cystic Fibrosis, 16(1), S155. ECFS 2017. Available .

Kirkpatrick S, Arden M, Beever D, Bradley J, Cantrill H, Daniels T, et al. 368 CFHealthHub: development and evaluation of videos incorporating peer description of successful self-management with inhaled therapies in adults with CF used to build self-efficacy to support self-care within the CFHealthHub complex intervention. Journal of Cystic Fibrosis, 16(1), S155-S156. ECFS 2017. Available .

Whelan P, Hassan L, Fox S, Tempest E. Developing Mobile Applications for Health, Informatics for Health Congress, April 2017.

Whelan, P. Data and mHealth Technologies, Digital Health Outlook, UK and Italy Experiences in a Global Context, Milan, 2017.

2016

Journal Articles

Hoo ZH, Curley R, Campbell MJ, Walters SJ, Hind D, Wildman MJ. (2016). Accurate reporting of adherence to inhaled therapies in adults with cystic fibrosis: methods to calculate "normative adherence". Patient Prefer Adherence. 2016;10:887‐900. doi:10.2147/PPA.S105530. Available .

Conference Abstracts

Arden MA, Drabble SJ, O’Cathain A, Hutchings M, Wildman M. (2016). WS16.1 ACtiF study: understanding adherence to nebuliser treatment in adults with cystic fibrosis using the Theoretical Domains Framework. Journal of Cystic Fibrosis, 15(1), S26. ECFS 2016. Available .

Arden MA, Drabble SJ, O’Cathain A, Hutchings M, Wildman M. (2016) Applying the theoretical domains framework to adherence to nebuliser treatment in adults with cystic fibrosis. Eur Heal Psychol [Internet]. 2016 Dec 31 [cited 2017 Jul 12];18(S):689. Available .

Sadler S, Wildman M, Tappenden P. 267 Cost-effectiveness of a complex adherence intervention to improve prevention in cystic fibrosis by empowering effective self-management: an exploratory health economic evaluation using UK Registry data. Journal of Cystic Fibrosis [Internet], 15(1), S119–S20. ECFS 2016. Available .

Whelan, P. Using digital platforms to improve the lives of people with chronic conditions: a connected health case study of CFHealthHub, University of Manchester, August 2016.

Whelan, P. Co-producing Digital Platforms to support an Ageing Population, Chengdu, China, July 2016.

Wildman M, Buchan I, Ainsworth J, Whelan, P. CFHealthHub: Complex intervention to support self-management in people with Cystic Fibrosis. Poster for Farr Institute case study.

2013

Conference Abstracts

C. Hinchliffe1, C. Rose1, M. Wildman1 Metrics that matter: making the invisible visible as adherence support moves a patient from a dependence on unscheduled rescue to planned prevention. ECFS 2013.