Adapting Health Programs: Our Step-by-Step Guide (CLARION)

Hey there! Let’s talk about something pretty important in the world of making health programs actually work for real people in real places. You see, creating a brand new health intervention from scratch? That’s a huge undertaking, like building a whole house. It takes tons of time, money, and effort. So, what if you could take a really good, proven program – maybe one that works wonders in a hospital setting – and tweak it just right so it works just as well, or even better, in a community center or for a different group of people? That’s where intervention adaptation comes in. It’s like renovating that house instead of building a new one – way more efficient!

But here’s the kicker: you can’t just willy-nilly change things. Imagine knocking down a load-bearing wall without knowing it – disaster! Some parts of a program are its ‘core components,’ the secret sauce that makes it effective. Mess with those without understanding them, and you might just break the whole thing. We noticed that while lots of smart folks agree adaptation is the way to go, the ‘how-to’ often felt a bit fuzzy. Frameworks existed, sure, but they sometimes lacked that nitty-gritty, step-by-step detail you need to actually *do* the work.

So, our team decided to roll up our sleeves and figure it out. We wanted a clear, solid way to adapt interventions that wasn’t just guesswork. We aimed to build something based on what research tells us works and what makes sense in the real world. And that’s how we developed what we call the ConsoLidated AppRoach to InteRvention adaptatiON – or CLARION for short. Catchy, right?

Why CLARION? Bridging the Gap

Think of CLARION as our answer to that ‘black box’ problem in adaptation. We wanted to pull back the curtain and show exactly how to go about it rigorously. Our goals were pretty straightforward:

• To lay out, step-by-step, how we developed CLARION, making sure it was rooted in both theory and evidence.
• To show you exactly how we used CLARION in a real-life project – adapting a depression self-management program.
• To share the good stuff (what made things easier) and the tough stuff (the challenges) we hit along the way, so hopefully, you won’t have to learn them the hard way!

We didn’t just invent CLARION out of thin air. We stood on the shoulders of giants! We looked at the Medical Research Council (MRC) guidance, which is super respected for developing complex interventions. We also drew heavily from something called the Method for Program Adaptation through Community Engagement (M-PACE). M-PACE was great because it really focused on involving the people who would actually use the program (patient-oriented research) and offered some concrete steps. But, after doing a deep dive into existing frameworks, we realized M-PACE was missing a few crucial pieces that other frameworks highlighted: how to pick the *right* intervention to adapt in the first place, how to truly understand its core components, and how to test out your adapted version *before* a big rollout (a ‘pre-test’). So, we blended the best parts, added those missing steps, and voila – CLARION was born!

CLARION ended up being structured in two main stages. Stage one is all about the initial heavy lifting: choosing your intervention, figuring out its core components, and deciding what needs changing. Stage two is where you take that preliminary adapted version and get feedback from the people who matter most – the stakeholders – to see if it’s acceptable. This paper focuses mainly on that first stage and our experience with it.

Putting CLARION to the Test: A Real-World Example

To really see if CLARION worked, we used it to adapt a specific program. We had this great self-management toolkit for depression called DIRECT-sc, designed for adults with chronic physical conditions. It was proven to help people manage their depression. But we heard from caregivers – unpaid family or friends who support these adults – that they wanted to know how they could best help. Depression doesn’t just affect the person with the condition; it impacts the whole family system. So, our mission was to adapt DIRECT-sc to include a specific role for caregivers, creating a new version we called DIRECT-support.

This wasn’t just a nice idea; the research shows that involving caregivers can really boost adherence and keep people engaged in programs, making them more effective. Plus, care recipients and caregivers navigate chronic illness together, so supporting both made a lot of sense.

Our adaptation journey with CLARION involved several key steps in Phase 1:

Step 1: Assembling Our Dream Team (Steering Committee)

First things first, you need the right people at the table. We pulled together a steering committee of 11 experts. This wasn’t just researchers; we made sure to include care recipients and caregivers themselves (we call them ‘patient partners’), healthcare professionals who work with this population, and even some folks who helped develop the original DIRECT-sc toolkit. Having this mix was crucial for getting diverse perspectives. We made sure our patient partners were compensated for their time, which is super important for valuing their invaluable input.

Step 2: Picking the Right Candidate (Selecting DIRECT-sc)

Before diving in, we needed to be absolutely sure DIRECT-sc was the best starting point. We did some serious homework – reviewing online programs and conducting two big meta-analyses (basically, studies of studies). This helped us confirm that yes, there was a real need for a program like DIRECT-support, that adapting DIRECT-sc made sense based on its track record, and it helped us start identifying what parts of DIRECT-sc were likely the ‘active ingredients.’ This step was a beast, taking over 18 months and needing specific research skills, but it was foundational.

Step 3: Unpacking the ‘Secret Sauce’ (Mechanisms and Core Components)

This is where we got theoretical! We dug into *why* DIRECT-sc worked. Based on our research, skills like decision-making, taking action, and problem-solving seemed key to its effectiveness. We linked these to two theories – the Individual and Family Self-Management Theory and Social Cognitive Theory – which helped us understand how the program’s content actually leads to change, especially when involving families. We worked closely with the original DIRECT-sc developers on our committee to make sure we really grasped which parts of the toolkit were tied to these core mechanisms. This meant we knew which parts to protect and modify minimally during adaptation. Having a clear ‘logic model’ – understanding how the program is supposed to work – was essential here.

Step 4: Hearing from the Experts (Identifying Potential Modifications)

Who better to tell you what needs changing than the people who will use it? We conducted interviews with adults with chronic conditions, their caregivers, and healthcare professionals. We gave them the original DIRECT-sc toolkit and asked for their honest feedback on how it could be adapted to include caregivers. This qualitative study was gold, giving us 35 unique suggestions for modifications. This step is crucial for making sure your adapted program is actually acceptable and useful to the target audience.

Step 5 e 6: Decision Time (Consolidating and Reviewing Modifications)

With 35 suggestions on the table, the steering committee had some work to do! We held three virtual meetings to discuss and decide on each proposed modification. To make things fair and efficient, we agreed on decision-making rules upfront. We decided to evaluate each suggestion based on three criteria from M-PACE: its importance for effectiveness and reach, its feasibility for users and providers, and its congruence – how well it fit with the program’s core components. If there was a disagreement, congruence with the core components was the tie-breaker. We even decided on a 75% supermajority rule for making decisions, rather than requiring full consensus, to keep things moving.

To streamline the meetings, we sent out a survey beforehand listing all 35 suggestions. Committee members gave their initial feedback based on the criteria. This helped us see which modifications everyone agreed on (saving meeting time) and which needed more discussion. Even with this, getting everyone together was tough, and integrating feedback from individual meetings (for those who couldn’t attend the main ones) was a challenge. By the end of the three meetings, we had decided to carry forward 27 modifications, mostly additions or refinements, and dropped 8, mainly because they weren’t feasible. This step really highlighted the value of having diverse perspectives, including the original developers who could speak to the program’s core mechanisms.

Lessons Learned: What Worked Well for Us

Using CLARION taught us a lot. Some things really helped us out:

• Crystal Clear Core Components: Spending time upfront to really understand the ‘why’ and ‘how’ of the original intervention’s effectiveness before suggesting changes was invaluable. It helped us protect what mattered most.
• Diverse and Balanced Committee: Having a mix of experts – researchers, clinicians, *and* patient partners, including the original developers – brought in all the necessary angles. Keeping the committee size manageable (11 people felt about right) helped balance getting diverse input with actually being able to make decisions efficiently.
• Rules of Engagement: Setting clear decision-making rules *before* diving into the modifications made the adjudication process much smoother. Everyone knew how decisions would be made.
• Pre-Meeting Prep: Using that online survey before meetings to get initial feedback on modifications was a game-changer for focusing discussions and saving time.

Bumps in the Road: The Challenges We Faced

Of course, it wasn’t all smooth sailing. We hit a few snags that are worth mentioning for anyone else using CLARION or a similar approach:

• Defining What Needs Committee Input: We struggled a bit with deciding which types of modifications *really* needed the full committee’s sign-off versus which could be handled by a smaller group or even just the project lead. Minor tweaks probably don’t need a supermajority vote!
• Committee Involvement Level: How much detail should the committee weigh in on? We found adjudicating 35 modifications against three criteria felt overly complex to some members. Simplifying the feedback process might be better.
• Getting Everyone Together: Coordinating schedules for 11 busy people was tough. Individual meetings helped include those who couldn’t make it, but it meant losing out on the valuable group discussion and sometimes made integrating feedback tricky.
• Understanding the Criteria: Even with defined criteria (importance, feasibility, congruence), their meaning wasn’t always crystal clear to everyone, highlighting the need for careful explanation and perhaps simpler terms.
• Resource Intensity: Steps like conducting meta-analyses (Step 2) were very time and resource heavy. While necessary for our project, they might not be essential if the intervention’s core components are already well-understood and documented.
• Integrating Patient Partners: While invaluable, ensuring patient partners felt fully integrated and comfortable, especially in group settings, required thoughtful planning. Offering different ways to contribute (like individual meetings or surveys) was helpful, but ideally, they’d also have peer support.
• Involving Original Developers: Including the original developers was fantastic for understanding the intervention’s history and core components. We didn’t face conflicts of interest, but the literature warns this is a potential issue that needs to be managed proactively (e.g., clear roles, documenting potential conflicts).

Making it Better: How to Navigate the Challenges

Based on our experience, here are a few thoughts on how to make the CLARION process even smoother:

• Clarify Mechanisms Early: Spend significant time upfront clearly linking the intervention’s content to its theorized mechanisms of action and core components. Using logic models and synthesizing existing evidence (like systematic reviews) is key.
• Plan Committee Feedback: Be explicit from the start about *when* and *how* the committee will provide feedback (e.g., after initial suggestions, after seeing a draft of the adapted materials, after pilot testing). Define the methods (meetings, email, surveys) and how many rounds of feedback are planned.
• Strategic Facilitation: Prepare meeting facilitation strategies in advance, especially for virtual meetings. Use techniques like anonymous surveys or ‘go-arounds’ to ensure everyone has a chance to contribute, and plan how to handle disagreements constructively. Address individual feedback within the group if possible to leverage collective wisdom.
• Streamline Decisions: Consider narrowing the scope of modifications that require full committee approval (e.g., exclude minor editorial changes). Explore tools like decision trees (like the IDEA tool mentioned in the literature) to guide the process. Agreeing on the level of input required for different types of decisions upfront can save time.
• Optimize Information Gathering: While literature reviews are necessary, full-blown meta-analyses might be overkill if the intervention’s core components are well-established. Consider focus groups instead of individual interviews for gathering modification suggestions – they can be more resource-efficient and generate synergy, though care is needed to ensure all voices are heard.
• Support Patient Partners: Provide clear information about roles, expectations, time commitment, and compensation from the very beginning. Offer training if needed and explore ways for patient partners to connect with each other for peer support. Be flexible in how they participate (group vs. individual).
• Manage Developer Involvement: If including original developers, have open discussions early about potential conflicts of interest, roles, and how disagreements will be handled. Document everything transparently.

Wrapping It Up

Developing CLARION and using it to adapt the DIRECT-sc toolkit into DIRECT-support was a fantastic learning experience for our team. We set out to create a more detailed, step-by-step approach to intervention adaptation that really put patients at the center and was grounded in evidence and theory. We think CLARION offers a solid blueprint for others looking to adapt interventions rigorously.

Of course, our experience is just one example. We don’t have a crystal ball to say for sure that using CLARION *guarantees* a more successful adaptation compared to other methods. That would require more research across different settings and interventions. But by sharing our process, the facilitators, and the challenges we faced, we hope to contribute to the growing conversation about best practices in this crucial area of research. Adaptation is key to getting effective health programs to the people who need them, and having clear, actionable guidance like CLARION is a big step in the right direction.

Source: Springer