B12 supplementation: Making the switch
A quality improvement project identifies challenges in transitioning to oral therapy
At Corydon Primary Care Clinic in Winnipeg, our team consists of registered nurses, nurse practitioners, physicians and primary care assistants (PCAs), supported by mental health professionals, a dietitian, a chronic disease specialist and a clinical pharmacist.
Approximately 180 of our patients have a B12 deficiency. A cohort of these patients were receiving supplementation parenterally despite the evidence supporting equivalency with oral B12. This group was making approximately 85 to 90 nursing visits to the clinic each year.
Because we were also seeing increased demand on nursing time in general, due to clinic efforts to maximize RN scope of practice, we projected that switching appropriate patients to oral B12 would increase capacity for the RNs to assume other responsibilities.
Recognizing that change is difficult for some patients, we wanted to identify which part of the change process would be a potential challenge if patients were given the option to switch to oral B12 supplementation.
We conducted a literature review and found a systematic review of randomized controlled trials (Butler et al., 2006) that demonstrated that oral and parenteral B12 therapy may be equivalent in terms of efficacy. We also found a recent Canadian publication that documented the financial benefits of oral B12 therapy (Houle, Kolber, & Chuck, 2014).
We located only one journal article that examined patient perspectives of oral B12 therapy. Kwong, Carr, Dhalla, Tom-Kun and Upshur (2005) found that when presented with the option of switching, most patients were willing to do so, citing personal convenience and overall cost savings to the health-care system. Their reasons for not wanting to switch varied from lack of knowledge about oral therapy to believing that injections were a more efficient method of B12 management. We found no literature regarding the perspectives of care providers.
Using these findings and recognizing the growing trend of treating B12 deficiency with oral supplementation, our clinic undertook a small quality improvement project aimed at transitioning patients to oral therapy.
We created surveys for patients and for physicians to help us understand their perceptions of IM and oral supplementation for B12 deficiency management. Each survey had open-ended and multiple-choice questions.
Twenty-five potential patient participants were flagged in the electronic medical record to be given a survey at their next appointment. We had given the PCAs who distributed this survey a script to follow to promote consistency with explanations. Those who completed surveys placed them in a sealed box at the front desk. Nineteen patients received surveys; 17 returned them.
Surveys for the physicians were placed on their individual computer keyboards, and we followed up with two reminder e-mails. Six physician surveys were distributed; one was returned.
Data collection took place over a two-month period in late 2014.
The patient cohort demographics for the 17 who completed surveys indicated that this group was primarily female, single and university educated, with low income and third-party insurance coverage. On average, these patients were taking four prescription medications and two over-the-counter medications. Geographic access and transportation did not appear to be barriers to accessing the clinic. Most were content with parenteral therapy. They indicated concerns about the effectiveness of oral supplementation, showed a lack of understanding of the pathophysiology of B12 deficiency and were reluctant to go against the physician’s advice — given that, in some cases, IM B12 had been prescribed for them for years. Most of the cohort had not tried oral therapy and indicated it had not been discussed as an option, but there was agreement that taking a pill would be easier than having injections at the clinic. A few patients indicated that they self-administer their own B12 IM injections.
The one physician who responded to the survey routinely recommends oral supplementation for B12 deficiency to patients to reflect evidence-based practice and said that 93 per cent of his patients with B12 deficiency are already on oral supplementation. He indicated that a lack of coverage for oral therapy under the provincial drug program was a barrier to switching for the remaining seven per cent.
Outcome: Change management
Realizing that encouragement from the physicians appeared to be an influential factor, we hosted a PowerPoint presentation and a question-and-answer session for them to ensure they had a thorough understanding of the pathophysiology of vitamin B12 deficiency and current supplementation guidelines. We also developed a handout with information geared to patients, designed to trigger a discussion of B12 management and provide the impetus for change.
The original group of 25 patients was again flagged in the EMR. At the patients’ next appointments, the physicians or registered nurses (depending on who was seeing the patient) were to present the handout and encourage the switch to oral B12.
Although most of the 25 identified patients had access to third-party insurance, oral B12 costs are not always covered; often, insurers use the provincial drug program as a guideline for which medications to cover.
Our retrospective chart review in late 2015 indicated that 35 per cent of this group were switched to oral B12 through the change management strategies we had developed. Another 19 per cent, all of whom were on government income support, would likely have switched if the supplement had been covered by the provincial drug program (IM B12 is currently covered by the drug program). Of the remaining identified patients, 15 per cent chose to continue monthly self-injection and 31 per cent continued to attend the clinic for parenteral B12 because they believed it to be the superior management method. This latter group might be willing to transition to oral B12 if they receive further support and education from the physicians.
Our next action was to produce a research poster that outlines the project and its findings in lay terms and then post it in our clinic waiting room. We also wrote to the Manitoba Drug Standards and Therapeutics Committee to recommend adding oral B12 to its list of eligible medications.
It was clear to us that patients were reluctant to switch unless the physicians encouraged them to. We had assumed that change would be difficult for patients. However, we underestimated the fact that change would also be challenging for some physicians and that many factors made the initiation of a change discussion between physician and patient difficult, including time constraints of appointments and the physicians’ lack of familiarity with the EMR (i.e., how to identify flagged messages).
Taking into account the relationship between an individual care provider and a patient, we believe it is important for members of interdisciplinary teams to reach consensus on evidence-based approaches to patient care to ensure good outcomes for patients and optimize scope of practice for members of each discipline.
This project highlights some of the challenges of collaboration in a practice environment that is guided by the principles of primary health care. Engagement of the whole team requires ongoing efforts by management as well as individual team members to ensure that a consistent message of high-quality evidence-based patient care is driving practice. Clinic-based quality improvement projects in a team setting such as ours enhance the evolution of clinical care approaches.
Butler, C. C., Vidal-Alaball, J., Cannings-John, R., McCaddon, A., Hood, K., Papaioannou, A., … Goringe, A. (2006). Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency: A systematic review of randomized controlled trials. Family Practice, 23(3), 279-285.
Houle, S. K., Kolber, M. R., & Chuck, A. W. (2014). Should vitamin B12 tablets be included in more Canadian drug formularies? An economic model of the cost-saving potential from increased utilisation of oral versus intramuscular vitamin B12 maintenance therapy for Alberta seniors. BMJ Open, 4(5) e004501.
Kwong, J. C., Carr, D., Dhalla, I. A., Tom-Kun, D., & Upshur, R. (2005). Oral vitamin B12 therapy in the primary care setting: A qualitative and quantitative study of patient perspectives. BMC Family Practice, 6(1).