The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD).
Anxiety
Chronic obstructive pulmonary disease (COPD)
Cognitive behavioural therapy (CBT)
Complex intervention
Depression
Implementation
Process evaluation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
26 Jul 2021
26 Jul 2021
Historique:
received:
20
11
2020
accepted:
15
07
2021
entrez:
27
7
2021
pubmed:
28
7
2021
medline:
29
7
2021
Statut:
epublish
Résumé
TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.
Sections du résumé
BACKGROUND
BACKGROUND
TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted.
METHODS
METHODS
We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated.
CONCLUSION
CONCLUSIONS
Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation.
TRIAL REGISTRATION
BACKGROUND
ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.
Identifiants
pubmed: 34311766
doi: 10.1186/s13063-021-05460-w
pii: 10.1186/s13063-021-05460-w
pmc: PMC8313120
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
495Subventions
Organisme : Health Technology Assessment Programme
ID : 13/146/02
Informations de copyright
© 2021. The Author(s).
Références
PLoS One. 2013 Apr 05;8(4):e60532
pubmed: 23585837
Neuropsychiatr Dis Treat. 2016 Feb 09;12:297-328
pubmed: 26929625
Implement Sci. 2019 Dec 11;14(1):103
pubmed: 31823787
BMJ. 2008 Sep 29;337:a1655
pubmed: 18824488
BMC Fam Pract. 2011 Mar 22;12:10
pubmed: 21426542
BMJ. 2015 Mar 19;350:h1258
pubmed: 25791983
J R Soc Med. 2016 Oct;109(10):364-366
pubmed: 27729592
Lancet. 2012 Dec 15;380(9859):2197-223
pubmed: 23245608
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
J Psychosom Res. 2007 Nov;63(5):551-65
pubmed: 17980230
Soc Sci Med. 2000 Apr;50(7-8):1001-14
pubmed: 10714922
BMJ Open. 2016 May 04;6(5):e011260
pubmed: 27147391
J Thorac Dis. 2014 Nov;6(11):1615-31
pubmed: 25478202
BMC Health Serv Res. 2018 Oct 19;18(1):794
pubmed: 30340639
Am J Community Psychol. 2009 Jun;43(3-4):267-76
pubmed: 19390961
Lancet. 2015 Mar 7;385(9971):830
pubmed: 25773073
Lancet. 2012 Dec 15;380(9859):2095-128
pubmed: 23245604
J Consult Psychol. 1957 Apr;21(2):95-103
pubmed: 13416422
Respir Res. 2017 Apr 21;18(1):67
pubmed: 28431503
BMJ Open. 2019 Nov 6;9(11):e031438
pubmed: 31699734
J Glob Health. 2015 Dec;5(2):020415
pubmed: 26755942
Cochrane Database Syst Rev. 2015 Feb 23;(2):CD003793
pubmed: 25705944
BMJ. 2011 Jan 24;342:d142
pubmed: 21262897
Qual Health Res. 1999 Jan;9(1):26-44
pubmed: 10558357
Eur Respir Rev. 2014 Sep;23(133):345-9
pubmed: 25176970
BMC Med. 2010 Oct 20;8:63
pubmed: 20961442
BMJ Open Respir Res. 2014 Nov 03;1(1):e000042
pubmed: 25478188
Evaluation (Lond). 2019 Jan;25(1):23-45
pubmed: 30705608
Implement Sci. 2018 Jun 7;13(1):80
pubmed: 29879986
Trials. 2021 Apr 6;22(1):252
pubmed: 33823935
Qual Quant. 2018;52(4):1893-1907
pubmed: 29937585
BMJ Qual Saf. 2015 Mar;24(3):228-38
pubmed: 25616279
J Epidemiol Community Health. 2015 Oct;69(10):925-6
pubmed: 25480407
Fam Pract. 2010 Jun;27(3):285-90
pubmed: 19875746
BMC Pulm Med. 2013 Nov 04;13:62
pubmed: 24498939
Health Psychol. 2004 Sep;23(5):443-51
pubmed: 15367063
Trials. 2020 Jan 6;21(1):18
pubmed: 31907074
Health Soc Care Community. 2017 Nov;25(6):1794-1804
pubmed: 28569395