Model
The systematic introducing approach is a procedure of seven steps. Figure 1 summarises the process:
Step 1: The model starts with defining which criteria to apply for the specific treatment. This requires discussion with hospital administrators responsible for budget allocation. We recommend keeping the criteria as strict as possible to optimize cost-effectiveness, especially when the treatment has not been widespread. Large scale clinical studies as well as established guidelines should be the foundation of the criteria.
Step 2: Start with the one or two main criteria and perform a primary scan to identify patients. This step is dependent on computerised medical records, databases or clinical registries.
Step 3: Perform a careful examination of the medical records of the identified patients to apply the other predefined criteria and sort out the patients who have contraindications to the treatment or are obviously not suited for other reasons.
Step 4: Evaluate if any examinations or laboratory test updates are required.
Step 5: Summon the identified patients with an information letter. The letter should contain short information about the new therapy and why they are summoned to the clinic.
Step 6: Discuss the new treatment option with the patient. Explain risks and benefits with the therapy and involve the patient in the treatment decision. Initiate treatment to appropriate patients.
Step 7: The final step is the follow-up with regards to adverse events, dose adjustments and other aspects depending on the initiated therapy. An evaluation of the process itself should also be performed to evaluate whether-or-not the prespecified criteria were useful in identifying the correct patients or if there would have been an easier way of identifying the patients.
Study population
Case study: Implementation of Sacubitril-Valsartan
Using the suggested model, we attempted a systematic introduction of sacubitril-valsartan in a single-centre heart failure clinic in the Umeå University Hospital, Sweden. The hospital represents the only cardiology clinic in the area, serving approximately 150,000 residents with a mixed rural and urban population. Patients could be included regardless of whether they usually were followed-up in primary or secondary care. The study was performed between April 2016 and January 2018.
In Step 1 discussions were held with the local pharmaceutical committee as well as with the head of the cardiology department who is responsible for the budget for cardiovascular pharmaceuticals. The decision was to use the strict entry criteria of the randomized controlled trial, PARADIGM-HF [10], which the approval of sacubitril-valsartan was based upon. Hence, the patients had to fulfil the following criteria; heart failure diagnosis, ejection fraction ≤ 35%, target dose ACE inhibitor or ARB, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 600 ng/L, systolic blood pressure ≥ 95 mmHg, estimated glomerular filtration rate (eGFR) ≥ 30 ml/min, serum potassium level < 5.4 mmol/L.
In Step 2 we used the medical record system of the hospital to identify patients with heart failure and at least one visit at the clinic between January 2010 and March 2016. All patients with an International Classification of Diseases, 10th revision code of heart failure (I50.X, I42.X, I11.0) were identified.
In Step 3 we performed a manual review of the medical records to further exclude patients whose condition had changed or because of other terminal illness were no longer suitable for sacubitril-valsartan.
In Step 4 we summoned the patients for an echocardiogram whose latest echocardiography was older than 18 months.
In step 5 identified patients were summoned with an information letter to an outpatient visit. The letter was written and signed by the heart failure cardiologist in charge of the program. A research nurse was responsible for sending the letters.
In Step 6 a heart failure cardiologist evaluated other therapies and discussed pros and cons of sacubitril-valsartan with the patient and prescribed the drug if both the physician and patient agreed.
Finally, in Step 7 follow-up was performed at 3 and 12 months and an additional 2-week follow up of blood pressure if systolic blood pressure was ≤ 110 mmHg at baseline visit. At 3 months the physician called the patients to ask about heart failure symptoms and adverse events. Laboratory tests and blood pressure measurements were repeated from baseline visit. At 12 months patients were summoned to an outpatient visit were treatment changes were discussed and the routine laboratory tests repeated.
Interview study: Patients experiences
We invited patients to participate in an interview at the baseline visit of the sacubitril-valsartan case study to investigate their perspective of the systematic introduction approach. A total of 24 interviews were conducted with 22 male and 2 female patients. We included patients consecutively but not all patients were interviewed. No patients declined to participate but some patients did not have the time to be interviewed before the scheduled baseline visit. All interviews were performed by one member of the research team trained to do semi-structured interviews. If the team member was unavailable at the baseline visit, no interview was conducted. Interviews followed a short interview guide, were audio-recorded and lasted for 10 to 25 minutes. For this study, one of the areas from the interview guide was analysed. This area was about the experience of being summoned to the outpatient visit with an information letter to discuss initiation of a novel drug. The interviews were transcribed verbatim and analysed using a general inductive approach with qualitative content analysis, inspired by Graneheim and Lundman [11]. Text segments corresponding to the aim of this study, were labelled with codes and further sorted into categories. Two members of the research team conducted the coding separately and afterwards discussed coding discrepancies to reach consensus of the final coding.