Kennedy et al. conducted a large effectiveness trial of an intervention designed to help chronically-ill patients manage their illnesses. Self-management is the simplest and most familiar medical practice: consider your daily habits of tooth care. In this study the patients had diabetes, chronic obstructive pulmonary disease, and irritable bowel syndrome, but the idea of promoting consistent daily self-care disciplines is the same. Self-management can allow patients to achieve a high quality of life while avoiding the side effects associated with medications or surgery. Self-management of chronic illness is one of the great hopes for improving patient outcomes while reducing costs.
The researchers were hoping to pull off a three-bank shot: The intervention was to train primary care practices in techniques for training patients in self-care behaviors that would improve the patients’ health. The well-designed experiment included 5,599 patients in 43 practices, so it had plenty of statistical power to find a moderate effect. This was an ‘effectiveness trial,’ which meant that its goal was to determine how well the intervention worked under everyday clinical conditions. The interventions had already been successfully tested in ‘efficacy’ trials. An efficacy trial is a clinical proof of concept study: Can you make the intervention work under well-controlled conditions using doctors who are committed to applying the treatment rigorously and, often, with patients who have been selected to make them ideal candidates for success? If the intervention works in an efficacy trial, the next question is: can you make it work in a typical practice using whatever patients they happen to be treating?
So what Kennedy and her colleagues found was that in the real world… training the primary care providers didn’t help patients at all.
With one exception, patients attending intervention practices and those attending control practices did not differ significantly on any primary or secondary outcome. The exception was shared decision making at the six month follow-up (P=0.05), with the difference favouring the control group… The lack of effect applied equally to the intermediate outcomes of shared decision making, self efficacy, enablement, and self care activity—which might reasonably be expected to be most directly affected by increased support for self management—as it did to health related outcomes.
So much for the great hope of empowering patients, improving outcomes, and reducing costs. As Teddy KGB said in Rounders:
It hurts doesn’t it? Your hopes dashed, your dreams down the toilet. And your fate is sitting right besides you.
Why didn’t it work? It seems that despite the training they received, the primary care providers changed their behaviour only to a limited degree.
Questionnaire data (a low response rate 48%) obtained from clinicians showed varying levels of implementation in routine practice… Across the 12 months of the study, similar percentages of intervention and control patients reported on each type of support, including receiving a guidebook (25% v 24%) and encouragement to use community programmes (19% v 20%) and patient support groups (11% v 12%).
So what do these results mean? I do not think they provide a reason to give up on patient self-management. What these results mean is that training alone rarely changes provider behaviour.
This has nothing to do with the character or personality of primary care docs, who are no better or worse than anyone else. The problem is that primary care providers work in highly constrained environments. Their routines of care have been set by years of training and decades of tradition, and are adapted to cope with a fire hose of patients and tasks. It takes more than brief training to change what docs do.
What is required, I think, is reorganization of the health care system to integrate primary care practices more tightly into medical systems. In that new system, promotion of patient self-management becomes the primary responsibility of a nurse or other physician extender. Patient self-management will not become a priority unless it becomes a permanent priority for the medical system and that system exerts incentives — carrots and sticks — to make sure that it happens.