Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation
Stephen J Walters,
Laura Mandefield,
Daniel Hind,
Alicia O'Cathain,
Madelynne A Arden,
Simon Waterhouse,
Chin Maguire,
Jane Dewar,
Martin J Wildman,
Alex Scott,
John Ainsworth,
Sam Keating,
Sarah J Drabble,
Hannah Cantrill,
Louisa Robinson,
Daniel Beever,
Marlene Hutchings,
Judy Bradley,
Julia Nightingale,
Mark I Allenby,
Pauline Whelan
Affiliations
Stephen J Walters
Medical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK
Laura Mandefield
Department of Health Sciences, University of York, York, UK
Daniel Hind
School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK
Alicia O'Cathain
School of Health and Related Research, University of Sheffield, Sheffield, UK
Madelynne A Arden
Centre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, UK
Simon Waterhouse
1University of Sheffield
Chin Maguire
Clinical Trials Research Unit, University of Sheffield, Sheffield, UK
Jane Dewar
Wolfson Cystic Fibrosis Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK
Martin J Wildman
2 School of Health and Related Research, University of Sheffield, Sheffield, UK
Alex Scott
Department of Physical Therapy, The University of British Columbia, Vancouver, British Columbia, Canada
John Ainsworth
Centre for Health Informatics, The University of Manchester, Manchester, UK
Sam Keating
1University of Sheffield
Sarah J Drabble
School of Health and Related Research, University of Sheffield, Sheffield, UK
Hannah Cantrill
Clincal Trials Research Unit, University of Sheffield, Sheffield, UK
Louisa Robinson
Clincal Trials Research Unit, University of Sheffield, Sheffield, UK
Daniel Beever
Clinical Trials Research Unit, University of Sheffield, Sheffield, UK
Marlene Hutchings
Sheffield Adult Cystic Fibrosis Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Judy Bradley
Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine Dentistry and Biomedical Sciences, Queen`s University Belfast, Belfast, UK
Julia Nightingale
University Hospital Southampton NHS Foundation Trust
Mark I Allenby
Wessex Adult Cystic Fibrosis Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK
Pauline Whelan
Health eResearch Centre – Division of Imaging, Informatics and Data Sciences, Faculty of Biology, Medicine and Health, The University of Manchester School of Health Sciences, Manchester, UK
Objectives To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability.Setting Two UK cystic fibrosis (CF) units.Participants Fourteen adult PWCF; three professionals delivering adherence support (‘interventionists’); five multi-disciplinary CF team members.Interventions Nebuliser with data recording and transfer capability, linked to a software platform, and strategies to support adherence to nebulised treatments facilitated by interventionists over 5 months (± 1 month).Primary and secondary measures Feasibility and acceptability of the intervention, assessed through semistructured interviews, questionnaires, fidelity assessments and click analytics.Results Interventionists were complimentary about the intervention and training. Key barriers to intervention feasibility and acceptability were identified. Interventionists had difficulty finding clinic space and time in normal working hours to conduct review visits. As a result, fewer than expected intervention visits were conducted and interviews indicated this may explain low adherence in some intervention arm participants. Adherence levels appeared to be >100% for some patients, due to inaccurate prescription data, particularly in patients with complex treatment regimens. Flatlines in adherence data at the start of the study were linked to device connectivity problems. Content and delivery quality fidelity were 100% and 60%–92%, respectively, indicating that interventionists needed to focus more on intervention ‘active ingredients’ during sessions.Conclusions The process evaluation led to 14 key changes to intervention procedures to overcome barriers to intervention success. With the identified changes, it is feasible and acceptable to support medication adherence with this intervention.Trial registration number ISRCTN13076797; Results.