Sunday, April 16, 2017
We're getting closer to starting up the first practices in the IBHPC protocol. So, it seems a good time to review the patient inclusion criteria. Who are we going to enroll and why?
The patients we are hoping to identify have at least one target chronic medical condition (arthritis, asthma, chronic obstructive lung disease (COPD), diabetes, heart failure (HF), or hypertension) and evidence of a behavioral problem or need. Such evidence may be a specific diagnosis (anxiety, chronic pain including headache, depression, fibromyalgia, insomnia, irritable bowel syndrome, problem drinking, or substance use disorder), persistent use of certain medications used for behavioral concerns (antidepressants, anxiolytics, opioids, anti-neuropathy agents, etc.), persistent failure to attain physiologic control of a medical problem (blood pressure>165 while on 3 or more medications, A1C > 9% for 6 months), or the presence of three or more of the target chronic medical conditions. (Patients with three or more of the target chronic medical problems almost always have a significant behavioral need.)
These criteria were chosen, with input from our patient advisory board, because they are commonly managed in primary care, associated with great burdens for patients, family, and the health system, have measurable outcomes, and are often associated with behavioral and lifestyle challenges such as medication non-adherence, stress, poor diet and inadequate exercise. In other words, they are the sorts of patients who most need IBH and can most benefit from it.
Our strategy for subject identification seeks to balance efficiency and representativeness while allowing us to capture the effects of each practice’s case finding and clinical management on study outcomes. We cannot sample from the entire practice panel because, in most cases, the practices will have many more patients that their BHCs can reasonably support. Nor can we allow each practice to know exactly who the study subjects are because they may tend to concentrate BH resources on those patients in a way not usual in real world practices. Therefore, we will create a “Community Panel” of about 1,000 adults per FTE BHC that the practice will be advised is the focus of integrated care (Group A). It comprises a general population of adults including those with and without BH needs. The Community Panel will be a random subset of the entire practice’s patient population of adults, regardless of diagnosis or need. Thus, the practice will need to employ whatever screening or case finding they have to find the members of the Community Panel who need BH services. The BHCs and other practice members will be told to apply their efforts in BH (including screening, case identification, management, follow-up, etc.) to those patients, but will not be told which of the patients in the panel has behavioral needs or is a research subject. (The practices will know the eligibility criteria.) The Community Panel will be substantially smaller than the number of primary care patients estimated to produce a work load for 1.0 FTE BHC. If the practice has more or less than 1.0 FTE BHC, the size of the community panel will be modified pro rata.
So, a practice with 1 full time BHC will receive a list of ~1,000 adults to focus their screening, case-finding and BH management on. That list will have a mix of folks with and without medical and behavioral issues and will include ~75 who will be research subjects and asked to report on how they are feeling (the main outcome). However, the practice will not know which of the bigger group are in the smaller group. Their job is to find them, assess them, manage them and do surveillance to make sure they stay well!
Let me know if you find this needs more clarification, or if you have any ideas for other postings. Also, feel free to post comments - you can even write your own posting, if you like!