Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD).
Anxiety
Chronic obstructive pulmonary disease (COPD)
Cognitive behavioural therapy (CBT)
Depression
Implementation
Intervention development
Self-management
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Apr 2021
06 Apr 2021
Historique:
received:
10
06
2020
accepted:
17
03
2021
entrez:
7
4
2021
pubmed:
8
4
2021
medline:
22
6
2021
Statut:
epublish
Résumé
Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process.
METHODS
METHODS
Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here.
RESULTS
RESULTS
Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation.
CONCLUSIONS
CONCLUSIONS
The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits.
TRIAL REGISTRATION
BACKGROUND
ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
Identifiants
pubmed: 33823935
doi: 10.1186/s13063-021-05203-x
pii: 10.1186/s13063-021-05203-x
pmc: PMC8025339
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
252Subventions
Organisme : Health Technology Assessment Programme
ID : 13/146/02
Références
Health Psychol Rev. 2020 Mar;14(1):188-192
pubmed: 31878842
J Patient Exp. 2019 Jun;6(2):117-125
pubmed: 31218257
J Glob Health. 2015 Dec;5(2):020415
pubmed: 26755942
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
NPJ Prim Care Respir Med. 2015 Sep 17;25:15054
pubmed: 26379121
Eur Respir Rev. 2014 Sep;23(133):345-9
pubmed: 25176970
J Psychosom Res. 2007 Nov;63(5):551-65
pubmed: 17980230
Lancet Respir Med. 2017 Sep;5(9):691-706
pubmed: 28822787
Int J Chron Obstruct Pulmon Dis. 2010 Oct 05;5:319-26
pubmed: 21037955
BMJ Open. 2019 Aug 15;9(8):e029954
pubmed: 31420394
BMC Med Res Methodol. 2013 Sep 18;13:117
pubmed: 24047204
Implement Sci. 2013 May 16;8:52
pubmed: 23680355
BMJ. 2008 Sep 29;337:a1655
pubmed: 18824488
BMJ Open. 2020 Apr 8;10(4):e033516
pubmed: 32273313
Am J Respir Crit Care Med. 2012 May 1;185(9):918-23
pubmed: 22246177
BMC Med. 2017 Mar 17;15(1):64
pubmed: 28302126
Pilot Feasibility Stud. 2019 Mar 12;5:41
pubmed: 30923626
Chron Respir Dis. 2014 May;11(2):95-102
pubmed: 24659210
Cochrane Database Syst Rev. 2015 Feb 23;(2):CD003793
pubmed: 25705944
NPJ Prim Care Respir Med. 2017 Jun 26;27(1):42
pubmed: 28652602
BMJ. 2013 Nov 20;347:f6753
pubmed: 24259324
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
J Psychosom Res. 2012 Nov;73(5):334-42
pubmed: 23062805
Lancet Respir Med. 2016 Mar;4(3):172-3
pubmed: 26872917
Respirology. 2012 May;17(4):627-38
pubmed: 22309179
Prim Care Respir J. 2011 Sep;20(3):257-68
pubmed: 21472192
Eur Clin Respir J. 2017 Jan 1;4(1):1332931
pubmed: 28649311
Cochrane Database Syst Rev. 2019 Mar 06;3:CD012347
pubmed: 30838649
BMJ Open Respir Res. 2014 Nov 03;1(1):e000042
pubmed: 25478188
J Consult Clin Psychol. 2005 Oct;73(5):852-60
pubmed: 16287385
Ann Behav Med. 2009 Oct;38(2):86-93
pubmed: 19513800
Pilot Feasibility Stud. 2015 Oct 26;1:37
pubmed: 27965815
Implement Sci. 2011 Apr 23;6:42
pubmed: 21513547
ERJ Open Res. 2018 Nov 23;4(4):
pubmed: 30479999
Eur Respir J. 2013 Apr;41(4):815-23
pubmed: 22878874
Behav Res Ther. 2009 Nov;47(11):910-20
pubmed: 19647230
BMC Pulm Med. 2013 Nov 04;13:62
pubmed: 24498939
Arch Intern Med. 2007 Jan 8;167(1):60-7
pubmed: 17210879
Thorax. 2010 Mar;65(3):229-34
pubmed: 20335292
PLoS One. 2016 Mar 15;11(3):e0150205
pubmed: 26978655
Trials. 2020 Jan 6;21(1):18
pubmed: 31907074
Int J Chron Obstruct Pulmon Dis. 2013;8:317-27
pubmed: 23874093
Health Psychol. 2015 Oct;34(10):971-82
pubmed: 25642841