• reduction in pain, sexual dysfunction, and depression symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

Background:

Of the many symptoms that frequently affect patients on hemodialysis, pain, sexual dysfunction, and depression are among the most prevalent, severe, and highly correlated with impaired quality of life. These observations are particularly noteworthy with the emergence of data documenting the safety and efficacy of pharmacologic therapy for these three symptoms. Nonetheless, preliminary studies suggest that even when severe, these symptoms remain untreated or under-treated in patients on chronic hemodialysis. The reasons for the inadequate implementation of therapy have not been clearly elucidated, but our research has demonstrated that renal providers are largely unaware of the presence and severity of pain, sexual dysfunction, and depression in their hemodialysis patients. Although increasing provider awareness of these symptoms would seem to be a necessary step for the provision of therapy, it is not clear that simply informing clinicians would be sufficient to improve treatment.

Objectives:

Objective: The broad objective of this 3-year project is to determine the most effective strategy for the management of pain, sexual dysfunction, and depression in patients on chronic hemodialysis.

Methods:

Research Design: In a randomized clinical trial of 245 patients receiving hemodialysis at 8 dialysis units, we will compare two symptom management strategies: (a) providing feedback on patients' symptoms to renal providers along with evidence-based algorithms for their treatment and; (b) using a renal symptom management nurse practitioner to identify and facilitate treatment of these symptoms.

Methodology: After enrollment, baseline data will be collected from all patients during a 6-month observation period. Pain, sexual dysfunction, depression, quality of life, and satisfaction with care will be assessed monthly during this observation period using validated symptom assessment instruments. Our assessment of sexual function will focus on erectile dysfunction in men, and decreased libido, arousal, dyspareunia, and satisfaction in women. We will also conduct monthly assessments of patients' attendance at dialysis, compliance with treatment duration, emergency room visits, and hospitalizations.

After the 6-month observational phase, we will launch a 12-month intervention phase to compare two interventions. During this phase, we will continue monthly assessments of pain, sexual dysfunction, depression, quality of life, and satisfaction with care. Patients will be randomized into one of two arms based on the day of their dialysis shift. In the first arm, the "feedback intervention," renal providers will receive data on the presence and severity of patients' pain, sexual dysfunction, and depression along with algorithms for the treatment of these symptoms (For sexual dysfunction, providers will receive a treatment algorithm for erectile dysfunction and a recommendation to refer women with this symptom for gynecologic care). Treatment decisions will be left at the discretion of the provider(s). In the second arm, the "management intervention," a renal symptom management nurse practitioner will assess and facilitate the treatment of pain, sexual dysfunction, and depression. In this arm, treatment of sexual dysfunction in men will focus on erectile dysfunction, while the symptom management nurse practitioner will facilitate referral of women with sexual dysfunction for gynecological care given the lack of pharmacologic therapy. We will continue to track attendance and compliance with dialysis, emergency room visits, and hospitalizations on a monthly basis during the intervention phase.

Status:

The project team is engaged in start-up activities.