You are here

Article Text

Article menu
XML
Respiratory medicine
Original research
Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation
  1. Daniel Hind1,
  2. Sarah J Drabble2,
  3. Madelynne A Arden3,
  4. Laura Mandefield4,
  5. Simon Waterhouse1,
  6. Chin Maguire1,
  7. Hannah Cantrill1,
  8. Louisa Robinson1,
  9. Daniel Beever1,
  10. Alex Scott1,
  11. Sam Keating1,
  12. Marlene Hutchings5,
  13. Judy Bradley6,
  14. Julia Nightingale7,
  15. Mark I Allenby7,
  16. Jane Dewar8,
  17. Pauline Whelan9,
  18. John Ainsworth9,
  19. Stephen J Walters2,
  20. Martin J Wildman2,5,
  21. Alicia O'Cathain2
  1. 1Clincal Trials Research Unit, University of Sheffield, Sheffield, UK
  2. 2School of Health and Related Research, University of Sheffield, Sheffield, UK
  3. 3Centre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, UK
  4. 4Department of Health Sciences, University of York, York, UK
  5. 5Sheffield Adult Cystic Fibrosis Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Sheffield, Sheffield, UK
  6. 6Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, UK
  7. 7Wessex Adult Cystic Fibrosis Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK
  8. 8Wolfson Cystic Fibrosis Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK
  9. 9Health eResearch Centre - Division of Imaging, Informatics and Data Sciences, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
  1. Correspondence to Dr Daniel Hind; d.hind{at}sheffield.ac.uk

Abstract

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.

  • cystic fibrosis
  • health informatics
  • clinical trials
  • statistics & research methods
  • social medicine
  • quality in healthcare
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2020-039089

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    Footnotes

    • Twitter @aliciaoc55

    • Contributors DH (Assistant Director, CTRU), SJD (Research Associate) and LM (Statistician), together produced the first draft of the report. The following authors conceived of or designed the work: MJW (Consultant Respiratory Physician), AO (Professor of Health Services Research), SJW (Professor of Medical Statistics and Clinical Trials), MAA (Professor of Health Psychology), MH (Physiotherapist), JB (Professor of Physiotherapy), JA (Professor of Health Informatics), DB (Patient and Public Involvement Representative) and DH. The following authors were involved in the acquisition of data for the work: JN (Consultant in Respiratory Medicine), MIA (Consultant in Respiratory Medicine), JD (Consultant in Respiratory Medicine), SJD, MAA, CM, HC, AS (Research Associate), SK (Research Associate), MH and PW (mHealth Applications Manager). The following authors were involved in the analysis of data: DH, SJD, AO, DB, AS, SK, MAA, LM, SW (Data Manager). DH, SJD, MAA, LM, SW, CM, HC, LR, MH, JB, JN, MIA, JD, DB, SJW, AO and MJW were involved in the interpretation of data for the work. All authors were involved in the final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding This report presents independent research funded by the NIHR under its Grants for Applied Research Programme (Grant Reference Number RP-PG-1212–20015).

    • Disclaimer The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.

    • Competing interests MJW received funding from Zambon and support from Philips Respironics for the early intervention development work. This has not had any direct influence on the feasibility study reported here. In addition, MJW has worked with Pari to carry out studies using the e-track. This has not had any direct influence on the feasibility study reported here. The University of Manchester software team received funding from Pari to create a medication reporting component within the CFHealthHub software. This has not had any direct influence on the feasibility study reported here.

    • Patient consent for publication Not required.

    • Ethics approval The study received ethical approval from the London Brent Research Ethics Committee (16/LO/0356).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available. Requests for further data not available in this publication can be directed at Sheffield Clinical Trials Research Unit. Email: ctru@sheffield.ac.uk Tel: 0114 222 0866.