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Chapter VI : Real-World Use

For Pragmatic Trials

Key Points

  • Key is the balance between assuring implementation of core components of intervention while allowing adaptation of non-essential components.

  • PRECIS-2 identifies two domains related to real-world use (i.e., flexibility -delivery and flexibility -adherence) 

  • How to achieve this balance is a challenge and ongoing issue- Main Approaches include;

    • data from prior implementation- aspects most strongly associated with outcomes;

    • in absence of this, theory of the intervention.

  • One approach that has been used is to standardize what needs to be done (for example, the 5 A’s), but to allow flexibility in how and to some extent who does this.

 

Learning Objective:

Characterize and resolve the tension between intervention fidelity and adaptation, which is often a key to success in real world application.

PRECIS-2 Domains for Real-World Use


There are many challenges in real world application and pragmatic research on implementation of evidence based interventions and guidelines. This section will focus on the tension between rigorous fidelity to validated intervention components and what is feasible in real world, and especially low resource settings. On one hand, the most common reason for failure to replicate positive intervention findings is failure to deliver the intervention as intended (Allen et al, 2012).  On the other hand, as discussed earlier, many settings do not have the resources, training or time to deliver interventions as evaluated in efficacy research.

 

Hover to Reveal Description

PRECIS-2 Domain:

Flexibility (delivery)

How different is the flexibility in how the intervention is delivered and the flexibility likely in usual care? 

PRECIS-2 Domain:

Flexibility (adherence)

How different is the flexibility in how participants must adhere to the intervention and the flexibility likely in usual care? 

Challenges Addressed

Flexibility (delivery)

Often, satisfactorily resolving the tension between intervention fidelity and adaptation to specific settings and conditions is key to success in real world use (Cohen et al, 2008).  PRECIS-2 addresses this in two categories: flexibility delivery and flexibility adherence. Flexibility delivery refers to how different flexibility in how the intervention is delivered is in the trial than in usual care. For example, if there is a strict protocol with close monitoring and frequent feedback to staff, this would be considered an explanatory trial and rated a 1 or 2 on the 5 point PRECIS scale.

Flexibility (adherence)

Parallel issues are relevant at the participant or patient adherence level, called flexibility adherence in PRECIS-2.  An intervention that closely monitors patients and has mechanisms to improve adherence, or even removes patients from the study because of non-adherence would be rated as very explanatory (1), whereas one that involves no more than usual encouragement that would be in usual care would be rated as very pragmatic (5).


One recommended approach for achieving balance between fidelity and adaptation has been to assure implementation of ‘core’ components of an intervention while allowing for customization of non-essential components (e.g., often the way a program is presented or what it is called).  

The 5 A's Model of Self-Management

Achieving the desired level of balance is admittedly a challenge and an ongoing issue throughout a trial.  Ideally, one would have data on the components of an intervention most strongly associated with outcomes to provide guidance.  In the absence of this, relying on the theory of the intervention can be used to identify core components.  For example, in working with different healthcare systems to implement the 5 As model of self-management (Glasgow et al, 2003), we have emphasized the importance of delivering each of the 5 As (Ask, Advise, Agree, Assist, Arrange) as core components, but that the specific forms used to counsel patients and how these elements are integrated into patient flow can be customized to the practice.

1

Ask

2

Advise

3

Agree

4

Assist

5

Arrange

Glasgow RE, Davis C, Funnell MM, Beck A. (2003)  Implementing Practical Interventions to Support Chronic Illness Self-Management in Health Care Settings:  Lessons Learned and Recommendations.  Joint Commission Journal on Quality and Safety 29(11):563-574. 

Applying PRECIS-2 Domains

More Pragmatic . . . 

More Explanatory . . .

Flexibility (delivery)

Identical flexibility to usual care

Has a strict protocol monitoring and measures to improve compliance

Flexibility (adherence)

No more than usual care encouragement to adhere
  • Exclusions based on adherence
  • Measures to improve adherence if suboptimal

Other Resources

Real-World Use Introduction: CRISP Pragmatic Trials Workshop September 2014

Russell Glasgow, PhD
Russell Glasgow reviews concepts addressed in this section and introduces some of the key issues related to real-world use of pragmatic trials.

Real-World Use: CRISP Pragmatic Trials Workshop September 2014

Jerry Krishnan, MD, PhD

 

Jerry Krishnan discusses real-world use of pragmatic trials, sharing the results of a study and comparing trial designs.

Real-World Use: CRISP Pragmatic Trials Workshop September 2014

William R. Hiatt, MD
Will Hiatt highlights the challenges to pragmatic trials in use and meaningful interpretation of results.

Key Takeaways

Click To Reveal Flipcard Answer

 A key to success is resolving the tension between which two aspects of an intervention?

Resolving the tension between intervention fidelity and adaptation is often the key to success.

According to Allen, et al (2012); the most common reason for failure to replicate positive intervention findings is:

failure to deliver the intervention as intended.

On the other hand, as discussed earlier, many settings do not have the resources, training or time to deliver interventions as evaluated in efficacy research.

List the 5 A's as in the model of self-management developed by Glasgow, et al.

  1. Ask
  2. Advise
  3. Agree
  4. Assist
  5. Arrange

References

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