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. Wildman; Alicia O'Cathain

doi:10.1136/bmjopen-2020-039089

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 journal › Article › peer-review

69 Downloads (Pure)

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 language	English
Article number	e039089
Number of pages	13
Journal	BMJ Open
Volume	10
Early online date	27 Oct 2020
DOIs	https://doi.org/10.1136/bmjopen-2020-039089
Publication status	Early 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)

Access to Document

10.1136/bmjopen-2020-039089Licence: CC BY

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation
Copyright 2021 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 1.33 MBLicence: CC BY

Cite this

Hind, D., Drabble, S. J., Arden, M. A., Mandefield, L., Waterhouse, S., Maguire, C., Cantrill, H., Robinson, L., Beever, D., Scott, A., Keating, S., Hutchings, M., Bradley, J., Nightingale, J., Allenby, M. I., Dewar, J., Whelan, P., Ainsworth, J., Walters, S. J., ... O'Cathain, A. (2020). Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation. BMJ Open, 10, [e039089]. https://doi.org/10.1136/bmjopen-2020-039089

@article{706531cdb5124c2f853f79a2c1c62ae6,

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

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 ({\^a} € 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 {\^a} € 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.",

keywords = "clinical trials, cystic fibrosis, health informatics, quality in healthcare, social medicine, statistics & research methods",

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

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: {\textcopyright} 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.",

year = "2020",

month = oct,

day = "27",

doi = "10.1136/bmjopen-2020-039089",

language = "English",

volume = "10",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

}

Hind, D, Drabble, SJ, Arden, MA, Mandefield, L, Waterhouse, S, Maguire, C, Cantrill, H, Robinson, L, Beever, D, Scott, A, Keating, S, Hutchings, M, Bradley, J, Nightingale, J, Allenby, MI, Dewar, J, Whelan, P, Ainsworth, J, Walters, SJ, Wildman, MJ & O'Cathain, A 2020, 'Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation', BMJ Open, vol. 10, e039089. https://doi.org/10.1136/bmjopen-2020-039089

TY - JOUR

T1 - Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

AU - Hind, Daniel

AU - Drabble, Sarah J.

AU - Arden, Madelynne A.

AU - Mandefield, Laura

AU - Waterhouse, Simon

AU - Maguire, Chin

AU - Cantrill, Hannah

AU - Robinson, Louisa

AU - Beever, Daniel

AU - Scott, Alex

AU - Keating, Sam

AU - Hutchings, Marlene

AU - Bradley, Judy

AU - Nightingale, Julia

AU - Allenby, Mark I.

AU - Dewar, Jane

AU - Whelan, Pauline

AU - Ainsworth, John

AU - Walters, Stephen J.

AU - Wildman, Martin J.

AU - O'Cathain, Alicia

N1 - 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.

PY - 2020/10/27

Y1 - 2020/10/27

N2 - 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.

AB - 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.

KW - clinical trials

KW - cystic fibrosis

KW - health informatics

KW - quality in healthcare

KW - social medicine

KW - statistics & research methods

U2 - 10.1136/bmjopen-2020-039089

DO - 10.1136/bmjopen-2020-039089

M3 - Article

C2 - 33109661

AN - SCOPUS:85094849959

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

M1 - e039089

ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

Fingerprint

Cite this