This study is seeking to identify the most effective strategy to manage pain, sexual
dysfunction, and depression in patients receiving chronic hemodialysis therapy.
There are currently over 500,000 individuals with end-stage renal disease (ESRD) in the
United States, and more than 100,000 new patients develop this condition annually. Recent
estimates suggest that more than 35,000 veterans currently receive chronic hemodialysis.
Although life-sustaining, hemodialysis is associated with substantial morbidity and
mortality. Numerous studies have sought to identify interventions that reduce the mortality
of patients dependent on hemodialysis, yet recent clinical trials of dialysis dose, dialysis
membrane, and lipid lowering therapy have failed to demonstrate survival benefits. With the
recognition that providers have limited means beyond renal transplantation to prolong the
lives of patients on hemodialysis, investigators are beginning to refocus their research
efforts on identifying interventions to improve patients' quality of life, which is
substantially impaired in this population. Several major factors that contribute to poor
quality of life have been identified, including the large burden of physical and emotional
symptoms in this patient population.
Of the many symptoms that 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 recent data documenting the
safety and efficacy of pharmacologic therapy for these symptoms. Nonetheless, preliminary
studies suggest that even when severe, these symptoms are untreated or under-treated in
patients on hemodialysis. The reasons for the sub-optimal treatment have not been clearly
elucidated, but the investigators research 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 important for the provision of therapy, it is not clear that simply informing
clinicians would be sufficient to improve treatment.
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. The investigators postulate that merely informing renal providers of patients'
pain, sexual dysfunction, and depression and providing them with evidence-based treatment
algorithms will not significantly improve the management of these symptoms. Rather, optimal
symptom management will require assessment and treatment of these symptoms by a dedicated
renal symptom management nurse. In a randomized clinical trial of not more than 350 patients
receiving hemodialysis at 9 dialysis units, the investigators 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 to identify and facilitate treatment of these symptoms. This study involves the nurse
and the research assistant bringing treatment plans and algorithms to the attention of the
renal providers and does not involve any treatment by the research assistant and nurse
themselves. By determining the most effective approach to the management of overall pain,
sexual dysfunction, and depression, the investigators hope to introduce a patient-centered
management approach to improve the quality of life of patients receiving chronic
METHODS: Overview of Study Design The investigators have proposed a randomized, clinical
trial to compare two strategies for the treatment of pain, sexual dysfunction, and
depression in patients on chronic hemodialysis. The investigators have recruited 315
patients from nine local VA and non-VA dialysis units.
After enrollment, baseline data was collected from 289 patients, and an observation period
of at least 2 months but not longer than 12 months ensued. Pain, sexual dysfunction, and
depression were assessed monthly during this observation period, which allowed us to
establish the stability of symptoms in study patients and obtain a valid estimate of the
impact of the investigators interventions on these domains. Additionally, quality of life,
overall symptom burden and satisfaction with care was assessed every 3 months. The
investigators assessment of sexual function focused on ED in men, and decreased libido,
arousal, dyspareunia, and satisfaction in women. The investigators also conducted monthly
assessments of patients' attendance at dialysis, compliance with treatment duration,
emergency room visits, and hospitalizations.
After the observational phase, the investigators launched a 12-month intervention phase to
compare two interventions. During this phase, the investigators continue these same
assessments of pain, sexual dysfunction, depression, quality of life, overall symptom burden
and satisfaction with care. The investigators continue to track attendance and compliance
with dialysis, emergency room visits, and hospitalizations on a monthly basis. Patients are
randomized into one of two study arms by day of dialysis treatment (Monday, Wednesday, and
Friday versus Tuesday, Thursday, and Saturday). Sites that only treat patients on a
Monday/Wednesday/Friday dialysis schedule are randomized by the time of the dialysis shift
within the day, patients on the a.m. shift are randomized to one arm of the study and those
on the p.m. shift to the other. One group is randomized to a "feedback intervention" in
which 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 ED and a
recommendation to refer women with this symptom for gynecologic care). Treatment decisions
will be left at the discretion of the provider(s). The other group has a renal symptom
management nurse assess and facilitate the treatment of pain, sexual dysfunction, and
depression (management intervention).In this arm, treatment of sexual dysfunction in men
will focus on ED, while the symptom management nurse will facilitate referral of women with
sexual dysfunction for gynecological care given the lack of pharmacologic therapy.
Study Status: Intervention Phase is completed, analysis is ongoing.
- Our target population is male and female hemodialysis patients age 18 years or
greater who are English speakers.
- We will exclude children because they comprise a minority of the dialysis population
and their enrollment would require an adult decision maker's consent.
- We will exclude patients who are significantly cognitively impaired and hence, unable
to comprehend study surveys.
- Cognitive function will be assessed at baseline using the mini-Cog, a validated
measure of cognitive capacity that we have used previously, and patients with scores
<3 will be excluded.
- Based on our prior studies, we estimate that approximately 5% of patients will be
excluded based on this criterion.
- Similarly, non-English speakers will be excluded.
- Finally, patients undergoing active work-up for living donor kidney transplant,
and/or considering transfer to peritoneal dialysis will be excluded as they are less
likely to remain on hemodialysis for the duration of the study.