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Complex Interventions in Healthcare

Table of Contents

Background

Intervention

Theory of change designing

Stakeholders

Theory of change map

Monitoring for mental health

Conclusion

References

Background of MRC Framework for Complex Interventions

The MRC framework for complex interventions theory of change is a real compliment to this framework to enable you to design and most importantly to evaluate a complex intervention are and how you develop a theory of change what one is and how you become a theory of change champion for your project. The third that's the second section of the talk is how you then take your theory of change and how you refine it to become the final theory of change for final intervention which you take forward for your formal evaluation and the third section of how you use the theory of change for the evaluation of complex interventions throughout. The last con they are challenged is everybody is very busy getting multiple people together for several hours is always challenging. We found a good kind of amount of time is to have say a morning where you would develop the initial theory of change and then you might go away type it up nicely and have another workshop a few days later where you reflect you get the group to reflect and modify and finalize the pathway and add the indicators and the assumptions and the rationale total you're looking at really about a day of people with time which could be split up and however it's appropriate for the context and in terms of follow up then so you've developed your theory of change you've got a map you might also want a narrative summary to describe the map and then you take that theory of change throughout your whole project you can refine and test the intervention and as a result refine and test the theory of change and then you take it to the final those kind of formal evaluation it might be a trial it might be non-randomized evaluation and then at the end of your evaluation you would refuse a theory of change and redraw it to reflect the reality of what you actually found so that your final theory of change is essentially a description of your program and how it worked in reality in that setting now. [1]

The MRC framework for complex interventions so the MRC framework is a framework for the steps you should take the methods you should use to design to refine and pilot and to test a complex intervention has many different active ingredients and combines different ingredients in a whole that's more than the sum of its parts. So, for example, something which seems quite simple like a vaccination it's a very complex intervention when delivered with Health System you have to have the cold supply-chain for the vaccination you have to ensure that people are adequately trained to deliver the vaccinations and you have to make sure that the people come to the clinic to get the vaccinations so that's an example of a complex intervention and pretty much every healthcare intervention is complex so the MRC framework has four stages which take you through how you can design and develop a complex intervention. The last con they are challenged is everybody is very busy getting multiple people together for several hours is always challenging. We found a good kind of amount of time is to have say a morning where you would develop the initial theory of change and then you might go away type it up nicely and have another workshop a few days later where you reflect you get the group to reflect and modify and finalize the pathway and add the indicators and the assumptions and the rationale total you're looking at really about a day of people with time which could be split up and however it's appropriate for the context and in terms of follow up then so you've developed your theory of change you've got a map you might also want a narrative summary to describe the map and then you take that theory of change throughout your whole project you can refine and test the intervention and as a result refine and test the theory of change and then you take it to the final those kind of formal evaluation it might be a trial it might be non-randomized evaluation and then at the end of your evaluation you would refuse a theory of change and redraw it to reflect the reality of what you actually found so that your final theory of change is essentially a description of your program and how it worked in reality in that setting now. [2]

So, in order to going back one more step in the pathway think about what would be the thing that would need to happen in order to make those outcomes actually happen in the real world so again the causal pathway so in order for the primary and secondary outcomes to be achieved what needs to happen is that the intervention the program needs to be delivered in the right way essentially so the mothers who've got depression must receive counselling as intended for the required duration so they receive the intervention they're adherent to the intervention and if that happens then it's much more likely that their outcomes will improve when carry on building up the causal pathway so in order for mothers to receive counselling is intended for the required duration the peer support workers the PSW is for short they need to have the skills to deliver the counselling to appropriately refer mothers who are too severely depressed to be treated by them and each specialist care and they need to be able to conduct me into your awareness raising and they are the components of the thinking healthy program peer delivery the PP program in order for the peer support workers to be able to deliver counselling and have all these skills they need to be situated within a health system which supports them so this step before that in the pathway is for the peer support workers to be in post and integrate it into the health system. [3]

Intervention

How you test that intervention and refine it through a feasibility and piloting process how you evaluate. Whether the intervention works and then finally what you do with the results of that implementation with that evaluation so implementing it in the real world and this is a great framework for use, but it has problems particularly. When you are trying to develop and evaluate two complex interventions in low resource settings and particularly when you are looking at health services research or complex health interventions the reason. Why the MRC framework is problematic is that it is not explicitly Theory driven so there are no underlying theories which capture the complex pathways through which sorry capture complex pathways through which an intervention affects. [14] Secondly, the MRC framework is very medical in its focus and often complex interventions include psychological and social interventions it's very patient-focused as opposed to looking at the whole health system which many complex interventions do and it assumes that you are in an in a setting where you have a well-resourced research staff that you have control over the setting that there's a high capacity for research so all of these issues mean that the MOC framework needs to be strengthened to be truly useful for evaluating complex interventions in low and middle-income countries in particular so the solution to strengthening the MRC framework is a thing called the theory of change. [4]

Theory of Change Designing

A real example of a project to show how we designed an evaluation strategy for a complex intervention using a theory of change framework. So, this program was called prime the program for improving mental health and it's a five country project whereby they worked in Ethiopia India Nepal Uganda in South Africa and in one district in each of those five countries we developed a mental health care plan which covered the treatment of depression psychosis and alcohol use disorders in epilepsy and we integrated treatment for these disorders into primary health care. It's an extremely complex intervention happening in lots of different contexts and in order to produce an overarching evaluation plan which could be used across all five countries. We developed first a theory of change which summarized how the intervention would work in all these five countries. This is the prime theory of change I think it shows the value of theory of change that a program that runs in five countries can be summarized on one a4 sheet of paper in a diagram so. The first exercise this theory of change and circle the primary outcome so which of the boxes on this pathway are the primary outcomes the long-term outcomes which are what we are aiming to achieve with this program. The primary the long-term and there you go so the last two outcomes before the ceiling of accountability our improved outcomes for people with mental disorders treated by the program and their families and carers and then secondly assuming that the program is working for people that there's an increased effective coverage of evidence-based mental health services so because we're working at a district level we can say that this program will be accountable for increasing effective coverage. [5]

Mental health services in the districts in which we're working now the next thing I want you to do is to circle all of the outcomes on this pathway which is the process outcomes so the things about how the actual program or the intervention was implemented they pause the recording and have a think about that. Picked this up basically every other outcome on this pathway is a process outcome and this really highlights one of the benefits of theory of change which is often when you do an evaluation people focus on the outcomes they focus on people getting better and they don't focus on. The process through which the intervention was implemented which made people get better and unless you properly evaluate the process you won't understand the how and the why the intervention worked and you won't understand why it worked in that context you'll only know whether it worked or not so the key thing about a process evaluation and about the benefit of using theory of change as a framework for your evaluation is that you find out what works for whom where and why here's a summary of the importance of having a good process evaluation the most important thing is that if your intervention doesn't work if your evaluation shows a null result you need to be able to know whether this is because the idea was a bad idea and essentially the intervention does not work all whether it was a failure of implement so was it that the intervention.[6]

Stakeholders

Through stakeholder buy-in and because the theory change map would be specific to each context in which you work it enables you to show how the context affects your intervention. Thirdly, it acknowledges the complexity of change so models such as a logical model or a logic model work in a linear fashion from inputs process outputs and outcomes there's no true reflection of a bit of the real pathway through which the intervention affects equally. Project cycle management is simply a cycle so you can't have feedback loops for example and a log frame has no structure at all no causal pathway in it so their change is fantastic and that you can you mocked in look exactly how the intervention is in the real world so it can reflect the reality of how your intervention works in the real world and you're not restricted by a particular structure fourthly. [13] Theory changes evidence-based but every stage of the causal pathway is evaluated through your evaluation plan it also measures not just activity. Such as a log frame for example how many people have you trained but it measures change so have those people that you have trained got the required skills to deliver the intervention effectively. If they have and only if they have can you then move to the next stage if they cause a pathway which is that people would receive the correct intervention as intended and it would be effective a log frame would just measure? The number of people that you've trained which doesn't tell you anything about whether the actual skills of those people are adequate to deliver the intervention and then the other benefit is that theory of change because it doesn't have any imposed pathways or any structure on it can represent change at many different levels so it's not uncommon to have a theory of change to have a Health Systems-level like for example the District Health Authority might have a whole series of activities at that level there might be activities at the facility level and also at the community level so again the theory of change is reflecting the reality of how your intervention works in the real world. [7]

Theory of Change Map

When you are creating a theory of change the first thing to do is to start with the thing that you're trying to achieve in the real world, and this is called your impact. So, in this case, I've decided that I would like to make my friends happy that's the thing I want to do it might be that you want to reduce the prevalence of malaria. It might be that you want to improve depression symptoms so whatever your thing in the real world you want to change and then once you've agreed that what your impact is going to be you start a process of working through the steps you would need to do to achieve that impact without having any preconceived ideas of what your actual intervention might be. So, in this case, my happy friends I'm there are lots of different ways that you could make your friends happy you could throw a party you could buy them a present you could send them a text lots of different things so the first kind of stage event is to understand which type of intervention is most likely to have an impact in your context so my context is that I enjoy cooking and so I would like to hold it a dinner party for my friends and previous evidence. [8] Suggests that good food makes people happy so there's kind of underlying evidence for why I would choose that intervention in this context. then start building up the cause will pass away the theory of change map you start with the things that you need to have to start so if I'm going to have a dinner party I need money to buy food and I need friends to invite and if I don't have those two things then the causal pathway ends there I can go no further and these are called intermediate outcomes the next thing that happens is that you have to do something to those intermediate outcomes you have to do interventions so. if you have money to buy food I then go shopping I'd do an intervention to go shopping and I send invites to my friends and that causes new outcomes to happen so we're moving up the causal pathway so I now have food available to be cooked and may have accepted the invites to my party and you keep on building up so. The next intervention is to cook the food and for my friends to travel to the party so you can see that those interventions there's already four different intervention components on the map and the value of this is that instead of having one big complex intervention which is in a big black box you understand which intervention component is acting on which part of the pathway so that when you evaluate that pathway you can say which components of the intervention were the most important and where did the pathway fall down so the next component of a theory of change map. [9]

Monitoring for Mental Health

The behaviour for mental health problems the stigma around seeking help and there's limited time and money to travel to what facilities there are available which provide mental health treatment. So, bearing in mind that context and the impact that we are trying to achieve there is a variety of different approaches that we could use a variety of different interventions that we could choose between. This is the kind of decisions that you make in your theory change workshop so one of the potential approaches you see your star shifting to use non-specialists because there simply aren't any mental health specialists in the community. [10] A particular type of we could use is community-based volunteer peer counsellors so using effectively other women from the community of high standing and training them to be paying counsellors. He provides psychological support to women with depression and the type of psychological support they could provide is cognitive behavioural therapy for which there is a huge amount to randomized. Control evidence that it works we just do not know whether it can be delivered by peer workers in rural India and also appreciating we need to raise community awareness so that people come and receive the intervention. Then we need to find the women from antenatal clinics to identify women with maternal depression postnatal depression so that we can put them into the treatment program so this is the kind of context within which we can build up our theory of change map and the thinking healthy program of these different approaches they decided to use tar shifting to community-based peer volunteers who would provide cognitive behavioural. [11] Therapy to mothers with depression so just to remind you of the different components of a theory of change map we have a causal pathway which shows the causal relationship between the intermediate outcomes leading to long term outcomes and the ultimate impact the interventions are used to bring about each of the outcomes on the pathway the rationale. Explains the logic behind each link in the pathway assumptions take the limits or the things that have the barriers that have to be overcome to move up through the causal chain and indicators are used to evaluate the whole of the program the whole of the theory of change and they must be specific enough to measure success so let's build up this theory of change then for the thinking healthy program in Goa so the first thing to decide is what is our impact and I want you to pause and maybe go back a couple of slides just to remember to think if you can write down what the impact is we're trying to achieve with this problem so hopefully you've had a think about what the impact is and hopefully you've come up with something similar which is a reduction in the treatment gap. [12]

Conclusion on MRC Framework for Complex Interventions

To separate your stakeholders into different groups then how you handle that can be a challenge the thing that we would suggest is to, first of all, have a high-level workshop with your policy planners your clinicians and then they would be the people that kind of outline the structure of the intervention and then you would present that structure to a workshop with perhaps community health workers and service users and careers in it to get their feedback on whether they think it would work which bits of the pathway problematic for missed anything what things could be added etc. [14]

References for MRC Framework for Complex Interventions

[1] Wenz-Gross W, DuBrino T. (2012) .Central Massachusetts Communities of Care: applying a theory of change approach to support implementation, evaluation, and strategic planning.

[2] Clarke DJ, Godfrey M, Hawkins R, Sadler E, Harding G, Forster A, et al. (2013). Implementing a training intervention to support caregivers after stroke: a process evaluation examining the initiation and embedding of programme change. Implementation Sci.;8(1):96. doi:10.1186/1748-5908-8-96.

[3] Schulz KF, Altman DG, Moher D. CONSORT (2010) statement: updated guidelines for reporting parallel group randomised trials. BMC Med.;8(1):18.

[4] Vandenbroucke JP, Von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. (2007) Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Ann Intern Med. 147(8):W-163–94.

[5] Möhler R, Köpke S, Meyer G. (2015) Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). Trials.;16(1):204.

[6] Prinsen G, Nijhof S. (2015) Between logframes and theory of change: reviewing debates and a practical experience. Dev Pract. ;25(2):234–46. doi:10. 1080/09614524.2015.1003532

[7] Endnote. Endnote. (2015) X7 ed. San Fransisco: Thomson Reuters.

[8] Evernote Cooperation. (2015) California: Evernote Corporation.

[9] Rivera JA, Martorell R, Gonzalez W, Lutter C, Cossio TG, Flores-Ayala R, et al. (2015). Prevención de la desnutrición de la madre y el niño: el componente de nutrición de la Iniciativa Salud Mesoamérica.

[10] Illinois Caucus for Adolescent Health. (2013) Strategic Plan. http://icah.org/ about/#strategic-plan.

[11] De Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, et al. (2014) Theory of Change: a theory-driven approach to enhance the Medical Research Council’s framework for complex interventions. Trials. 15:267. doi:10.1186/1745-6215-15-267.

[12] Breuer E, De Silva M, Fekadu A, Luitel N, Murhar V, Nakku J, et al. (2014) Using workshops to develop theories of change in five low and middle income countries: lessons from the programme for improving mental health care (PRIME). Int J Ment Health Syst. 8(1):15

[13] Statcorp. STATA. (2013) 13th ed. College Station: Statcorp.

[14] Basson HA, Roets L. (2013) Workplace wellness for HIV/AIDS affected nurses in South Africa. Br J Nurs. 22(1):38–44.

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