Research made simple: developing complex interventions
======================================================

* Alison Rodriguez
* Joanna Smith
* David Barrett

*   palliative care
*   qualitative research
*   statistics & research methods

In common with many other countries, population ageing, advancements in medical technology, changing disease profiles, the influence of lifestyle choices on health and increased patient expectations are driving health and social care provision in the UK. As the number of people living with one or more long-term conditions rises, interventions to support their health and well-being become increasingly complex. Nurses will not only be expected to deliver complex interventions but are in an ideal position to contribute to priority setting and the development and evaluation of interventions that meet patient needs. It is essential that complex interventions are based on the best available evidence and evaluated if they are to improve health outcomes. In this article we will provide an overview of complex interventions, using dignity therapy as an example, and outline the principles of developing a complex intervention.

## What is a complex intervention?

The UK Medical Research Council (MRC) defines complex interventions as those with several interacting components.1 In addition, interventions can be thought of as complex if they are dependent on the behaviours of those delivering and receiving the intervention, there are a range of possible outcomes, or there is a need to tailor the intervention to different contexts and settings.1 

In palliative and end of life care (EoLC) settings, helping people make sense of their lives is as important as managing disease symptoms. Dignity therapy (DT) is a validated psychotherapeutic intervention designed to bring about a sense of meaning and purpose for individuals at the end of life.2 DT addresses psychosocial and existential distress by encouraging patients through focused interviews to discuss valued memories, accomplishments, roles, life lessons and hopes for significant others. Interviews are recorded, transcribed, edited and transcripts returned to the patient, who can add to the document. The format of the documents, typically labelled a ‘generativity document’ or ‘written legacy’, is evolving, for example, picture books, including cherished photos alongside briefer key commentaries. Many patients share these documents with significant others, providing opportunity for meaningful conversations that can assist with the bereavement processes. DT can be thought of as a complex intervention because: (1) DT is dependent on the skills of professionals delivering the intervention and the receptiveness of those receiving the intervention; (2) there are a range of outcomes measures that can evaluate the effectiveness of DT such as the Dignity Impact scale3 (a new measure specifically developed as an outcome measure for DT, measuring influences on the spiritual domain of well-being including meaning making, preparation for death and life completion tasks), The Palliative Performance Scale4 (assesses psychological, existential and spiritual distress), anxiety/depression scales5 and the patient dignity inventory6 (a measure of dignity-related distress); (3) DT needs to be tailored to different service settings and patient illness trajectories.

## What are the key stages in developing a complex intervention?

Although MRC guidance on complex intervention1 has been in existence since 2000, methodological development is continuing to progress at a rapid pace. Although multicomponent interventions will be necessary to support patients and their families in an increasingly complex healthcare environment, the reporting of complex interventions has been criticised for not always including all ‘ingredients’ of the intervention.7 For intervention development to be successful, rigorous, structured and methodologically appropriate processes must be followed.8 Involvement of stakeholders throughout the development process is central to producing an intervention that is fit for purpose that meets both health professional and patient needs, and ensures implementation is well-adopted.9 Furthermore, the MRC guidelines on complex intervention development emphasise that interventions must be theory-driven in order to understand how they work and in order to achieve the best outcomes.1 A poorly conceptualised phenomenon results in interventions that are rarely well developed.10 

The Methods Of Researching End of life Care (MORECare)11 statement builds on the MRC guidance in relation to best practice and solutions to developing and evaluating complex interventions within EoLC. It is important to combine MRC guidance with guidance that supports best practice in terms of research design/population needs.11 Table 1 provides a brief summary of the stages that guide the development of complex interventions based on a widely adopted framework developed by O’Cathain and colleagues, combined with components of the MORECare statement that are particularly pertinent to EoLC interventions, such as DT.8 11 In addition to effective planning and meaningful stakeholder engagement, the development of a complex intervention includes synthesising the evidence, understanding how the intervention would changes behaviours by drawing on existing theory, and patient-focused research to identify its components.

View this table:
[Table 1](http://ebn.bmj.com/content/23/2/35/T1)

Table 1 
Framework for developing a complex intervention8 applied to EoLC interventions and MORECare guidelines11 

In relation to DT, the intervention evolved from the Dignity Conserving Model of Care (DCMC).12 The DCMC, the theoretical/conceptual framework underpinning DT was developed from detailed qualitative work. Participants comprised a range of stakeholders including patients and their families, who were invited to explore what constitutes dignity and how it can be achieved or maintained through experiences, cares and interactions. The model contains several themes and related subthemes that informed the schedule of questions and tenor of DT.2 Table 2 provides a brief summary of each theme/component of the DCMC12 13 and highlights how each theme has influenced DT. Following its initial development, the effectiveness of DT has been studied in feasibility and randomised control trial studies to evaluate its value for different patient populations and their families.14 To date, DT is proving to be a supportive psychotherapeutic intervention for middle-aged and older adults.14 However, further studies are required to develop DT as a complex intervention to support the needs of younger life-limited populations.15 16 

View this table:
[Table 2](http://ebn.bmj.com/content/23/2/35/T2)

Table 2 
DCMC and DT12 13 

In summary, we offer some key considerations to successful complex intervention development in healthcare, with additional considerations for EoLC studies, highlighting through the example of DT as a complex intervention. Research evidence, using mixed methods approaches and theory, inform the content, structure and delivery of complex interventions to increase the likelihood of them being effective. Collaboration with stakeholders through all stages of development, testing and implementation can enhance the perceived value, efficacy and effectiveness of complex interventions.

## Footnotes

*   Twitter @ARodriguez339, @josmith175, @barrett1972

*   Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

*   Competing interests DB is an Associate Editor for Evidence Based Nursing Journal.

*   Patient consent for publication Not required.

*   Provenance and peer review Not commissioned; internally peer reviewed.

## References

1.   Craig P , Dieppe P , Macintyre S , et al . Developing and evaluating complex interventions: the new medical Research Council guidance. The BMJ 2008;337.
    
    

2.   Chochinov HM , Hack T , Hassard T , et al . Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol 2005;23:5520–5.[doi:10.1200/JCO.2005.08.391](http://dx.doi.org/10.1200/JCO.2005.08.391) 
    
    [Abstract/FREE Full Text](http://ebn.bmj.com/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6MzoiamNvIjtzOjU6InJlc2lkIjtzOjEwOiIyMy8yNC81NTIwIjtzOjQ6ImF0b20iO3M6MjA6Ii9lYm51cnMvMjMvMi8zNS5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30=) 

3.   Scarton L , Oh S , Sylvera A , et al . Dignity impact as a primary outcome measure for dignity therapy. Am J Hosp Palliat Care 2018;35:1417–20.[doi:10.1177/1049909118777987](http://dx.doi.org/10.1177/1049909118777987) 
    
    

4.   Anderson F , Downing GM , Hill J , et al . Palliative performance scale (PPS): a new tool. J Palliat Care 1996;12:5–11.[doi:10.1177/082585979601200102](http://dx.doi.org/10.1177/082585979601200102) 
    
    [PubMed](http://ebn.bmj.com/lookup/external-ref?access_num=8857241&link_type=MED&atom=%2Febnurs%2F23%2F2%2F35.atom) 
    
    [Web of Science](http://ebn.bmj.com/lookup/external-ref?access_num=A1996UG06700002&link_type=ISI) 

5.   Snaith RP . The hospital anxiety and depression scale. Health Qual Life Outcomes 2003;1:29.[doi:10.1186/1477-7525-1-29](http://dx.doi.org/10.1186/1477-7525-1-29) 
    
    

6.   Chochinov HM , Hassard T , McClement S , et al . The patient dignity inventory: a novel way of measuring dignity-related distress in palliative care. J Pain Symptom Manage 2008;36:559–71.[doi:10.1016/j.jpainsymman.2007.12.018](http://dx.doi.org/10.1016/j.jpainsymman.2007.12.018) 
    
    [CrossRef](http://ebn.bmj.com/lookup/external-ref?access_num=10.1016/j.jpainsymman.2007.12.018&link_type=DOI) 
    
    [PubMed](http://ebn.bmj.com/lookup/external-ref?access_num=18579340&link_type=MED&atom=%2Febnurs%2F23%2F2%2F35.atom) 
    
    [Web of Science](http://ebn.bmj.com/lookup/external-ref?access_num=000262023500001&link_type=ISI) 

7.   Harris J , Croot L , Thompson J , et al . How stakeholder participation can contribute to systematic reviews of complex interventions. J Epidemiol Community Health 2016;70:207–14.[doi:10.1136/jech-2015-205701](http://dx.doi.org/10.1136/jech-2015-205701) 
    
    [Abstract/FREE Full Text](http://ebn.bmj.com/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiamVjaCI7czo1OiJyZXNpZCI7czo4OiI3MC8yLzIwNyI7czo0OiJhdG9tIjtzOjIwOiIvZWJudXJzLzIzLzIvMzUuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

8.   O'Cathain A , Croot L , Duncan E , et al . Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open 2019;9:e029954.[doi:10.1136/bmjopen-2019-029954](http://dx.doi.org/10.1136/bmjopen-2019-029954) 
    
    

9.   Turner KM , Rousseau N , Croot L , et al . Understanding successful development of complex health and healthcare interventions and its drivers from the perspective of developers and wider stakeholders: an international qualitative interview study. BMJ Open 2019;9:e028756.[doi:10.1136/bmjopen-2018-028756](http://dx.doi.org/10.1136/bmjopen-2018-028756) 
    
    

10.  De Silva MJ , Breuer E , Lee L , et al . Theory of change: a theory-driven approach to enhance the medical Research Council's framework for complex interventions. Trials 2014;15:267.[doi:10.1186/1745-6215-15-267](http://dx.doi.org/10.1186/1745-6215-15-267) 
    
    

11.  Higginson IJ , Evans CJ , Grande G , et al . Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews. BMC Med 2013;11:111–22.[doi:10.1186/1741-7015-11-111](http://dx.doi.org/10.1186/1741-7015-11-111) 
    
    [CrossRef](http://ebn.bmj.com/lookup/external-ref?access_num=10.1186/1741-7015-11-111&link_type=DOI) 
    
    [PubMed](http://ebn.bmj.com/lookup/external-ref?access_num=23618406&link_type=MED&atom=%2Febnurs%2F23%2F2%2F35.atom) 

12.  Chochinov HM . Dignity-conserving care--a new model for palliative care: helping the patient feel valued. JAMA 2002;287:2253–60.[doi:10.1001/jama.287.17.2253](http://dx.doi.org/10.1001/jama.287.17.2253) 
    
    [CrossRef](http://ebn.bmj.com/lookup/external-ref?access_num=10.1001/jama.287.17.2253&link_type=DOI) 
    
    [PubMed](http://ebn.bmj.com/lookup/external-ref?access_num=11980525&link_type=MED&atom=%2Febnurs%2F23%2F2%2F35.atom) 
    
    [Web of Science](http://ebn.bmj.com/lookup/external-ref?access_num=000175260600025&link_type=ISI) 

13.  Chochinov HM . Dignity Therapy: Final words for final days. New York: Oxford University Press, 2012.
    
    

14.  Martínez M , Arantzamendi M , Belar A , et al . ‘Dignity therapy’, a promising intervention in palliative care: A comprehensive systematic literature review. Palliat Med 2017;31:492–509.[doi:10.1177/0269216316665562](http://dx.doi.org/10.1177/0269216316665562) 
    
    

15.  Rodriguez A , Smith J , McDermid K . Dignity therapy interventions for young people in palliative care: a rapid structured evidence review. Int J Palliat Nurs 2018;24:339–49.[doi:10.12968/ijpn.2018.24.7.339](http://dx.doi.org/10.12968/ijpn.2018.24.7.339) 
    
    

16.  Watts L , Rodriguez A , Tatterton M , et al . Meaning making and Generativity in children and young people with life limiting conditions (MAGICYL). Evid Based Nurs 2019;22:33–5.[doi:10.1136/ebnurs-2019-103075](http://dx.doi.org/10.1136/ebnurs-2019-103075) 
    
    [Abstract/FREE Full Text](http://ebn.bmj.com/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NjoiZWJudXJzIjtzOjU6InJlc2lkIjtzOjc6IjIyLzIvMzMiO3M6NDoiYXRvbSI7czoyMDoiL2VibnVycy8yMy8yLzM1LmF0b20iO31zOjg6ImZyYWdtZW50IjtzOjA6IiI7fQ==)