Key result
Intensive pharmaceutical care significantly improved application quality scores (1.22 vs 1.02, p<0.01) and knowledge scores compared to standard care in outpatients self-injecting low-molecular-weight heparin.
Why the study?
Does pharmaceutical care improve application quality and adherence in patients self-administering outpatient low-molecular-weight heparin therapy?
RCT (n=139)
Open-label
1:1 using a research randomizer (for clinical setting arm)
Yes
Does pharmaceutical care improve application quality and adherence in patients self-administering outpatient low-molecular-weight heparin therapy?
Community-pharmacy-based pharmaceutical care using a standard operating procedure improves the application quality of self-administered subcutaneous low-molecular-weight heparin.
Supports adoption of intensive pharmaceutical care for outpatient LMWH self-injection; confirms RCT benefits on application quality.
Outpatient subcutaneous (s.c.) therapies are becoming more and more common in the treatment of different diseases. The effectiveness of community-pharmacy-based interventions in preventing problems that arise during s.c. self-injections of low-molecular-weight heparins (LMWH) is unknown. Our objective was to provide a standard operating procedure (SOP) for community pharmacists and to compare pharmaceutical vs. standard care in both clinical and daily life settings. We hypothesized that: pharmaceutical care results in improved adherence, safety, and satisfaction, and in fewer complications; the interventions used are feasible in daily life; and the results achieved in clinical and daily life settings are comparable. In the clinical setting (randomized controlled trial), patients were recruited sequentially in hospital wards; in the daily life setting (quasi-experimental design with a comparison group), recruitment took place in community pharmacies by pharmacists and trained master students during their internship. Interventions were offered according to patient needs. Data were collected by means of a monitored self-injection at home and structured questionnaire-based telephone interviews at the beginning and the end of the LMWH treatment. The main outcome measures were: scores to assess patient’s skills; syringe count to assess adherence; and frequency, effectiveness, and patient’s assessment of received interventions. The results show a median age of the 139 patients of 54 years. Interventions resulted in improved application quality (p p = 0.03). Oral instructions were pivotal for improving patients’ application quality. We found no significant score differences between the intervention groups in the clinical and daily life settings. Patients’ baseline skills were high, with the lowest score being 0.86 (score range ?2.00 to +2.00). Adherence rate was high (95.8%). In conclusion, our SOP for pharmacist interventions was of good quality, adequate, appreciated, and feasible in daily life. Patients are capable of managing s.c. injection therapies if adequate assistance is provided.
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Mengiardi et al. (2014) conducted an RCT in Outpatient low-molecular-weight heparin (LMWH) therapy (n=139). Intensive pharmaceutical care (standard operating procedure) vs. Standard care was evaluated on Application quality score (range -2.00 to +2.00) assessed by directly observed therapy (p=<0.01). Intensive pharmaceutical care significantly improved application quality scores (1.22 vs 1.02, p<0.01) and knowledge scores compared to standard care in outpatients self-injecting low-molecular-weight heparin.
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