Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

Daniel Hind*, Sarah J. Drabble, Madelynne A. Arden, Laura Mandefield, Simon Waterhouse, Chin Maguire, Hannah Cantrill, Louisa Robinson, Daniel Beever, Alex Scott, Sam Keating, Marlene Hutchings, Judy Bradley, Julia Nightingale, Mark I. Allenby, Jane Dewar, Pauline Whelan, John Ainsworth, Stephen J. Walters, Martin J. WildmanAlicia O'Cathain

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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 (â € 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 â € 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.

Original languageEnglish
Article numbere039089
Number of pages13
JournalBMJ Open
Volume10
Early online date27 Oct 2020
DOIs
Publication statusEarly online date - 27 Oct 2020

Bibliographical note

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

Funding Information:
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.

Publisher Copyright:
© 2020 Author(s) (or their employer(s)). Re-use permitted under CC BY. Published by BMJ.

Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.

Keywords

  • clinical trials
  • cystic fibrosis
  • health informatics
  • quality in healthcare
  • social medicine
  • statistics & research methods

ASJC Scopus subject areas

  • Medicine(all)

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