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SQ Works! Assessing the Efficacy of an Established Method for Successful Subcutaneous Treprostinil: A Formal Study of Aggressive Pain Management and Infrequent Site Changes

Karen Frutiger

Antonia Heininger

K. Wessman


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Conference: 2011 PH Professional Network Symposium

Release Date: 09.22.2011

Presentation Type: Abstracts

K. Frutiger, RN, BS, A. Heininger, BA, K. Wessman RN, R.J. White, MD, PhD
University of Rochester Medical Center, Rochester, NY

PURPOSE: Our specific aims were to: 1) collect prospective information and follow outcomes such as infusion site longevity, site pain intensity, and incidence of significant infections in consecutive patients using subcutaneous treprostinil infusion, and 2) assess patients' perspectives on quality of life. Patients were asked to record via diary reasons for changing infusion sites, quantitative site pain assessments and pharmacologic and non-pharmacologic management strategies.

BACKGROUND/SIGNIFICANCE: Subcutaneous treprostinil used for treatment of pulmonary arterial hypertension (PAH), a devastating disease with a poor prognosis, has been shown to be safe and efficacious but may present challenges to both patients and PAH providers due to the well described incidence of site pain and reaction. Experienced PAH centers have adopted management techniques that have improved patient tolerance and success with this therapy, as well as allowed for avoidance of the risks and complexity involved with intravenous prostanoid therapy. We hypothesized that aggressive educational and therapeutic subcutaneous management strategies would lead to positive patient experience and outcome.

METHODOLOGY: Twenty-six prevalent WHO Group 1 PAH patients receiving subcutaneous treprostinil therapy were enrolled. Patients were provided with diaries to standardize information collection and written instructions for managing infusion site discomfort. Consistent communication was employed between patient and nursing staff, including prospective patient education and reinforcement of structured site management tools. These consistent follow-up phone calls and office visits were also used to increase compliance with data collection. The CAMPHOR (PAH-specific quality of life instrument) and TSQM (Treatment Satisfaction Questionnaire for Medication) were administered at beginning and end of the one year assessment period.

FINDINGS/RESULTS: Twenty-one of 26 enrolled patients completed the study: two subjects died (likely from PAH), one received lung transplant and two were terminated due to data collection non-compliance. Data from all but the two early terminated subjects were analyzed. Median duration of subcutaneous sites for 177 sites with definite start and stop dates was 30 days, with the longest site duration equaling 225 days. Throughout the study, most subcutaneous infusion sites required only topical skin care rather than more complex wound care or systemic antibiotics. No patients were admitted for medical management of site-related complications. Our analysis revealed maintained or improved perceived quality of life from study initiation to completion. Lack of a significant difference between entry and exit patient survey data indicates that management of medication regimen and disease overall did not cause additional patient burden. Finally, enrolled patients experienced a low number of hospitalizations, no significant site infections, infrequent site changes, high site viability and extended site duration.

IMPLICATIONS: With education and healthcare team support, subcutaneous treprostinil is a viable, manageable and successful strategy for treatment of PAH patients. The consistent communication between patient and nursing staff, including prospective patient education and continued reinforcement of structured site management tools, in the context of follow-up phone calls and office visits can help decrease site reaction and pain leading to maintained or improved quality of life.