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IIR 07-190 – HSR&D Study

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IIR 07-190
Pain, Sexual Dysfunction and Depression in Hemodialysis Patients
Steven D. Weisbord MD MSc
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, PA
Funding Period: August 2008 - January 2012

BACKGROUND/RATIONALE:
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. Preliminary studies suggest that even when severe, these symptoms commonly remain untreated or under-treated. 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 these symptoms 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.

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

Specific Aim 1: To compare the effectiveness of two strategies for the treatment of pain, sexual dysfunction, and depression in patients receiving hemodialysis.
Hypothesis: A symptom management strategy in which a trained nurse identifies the presence of pain, sexual dysfunction, and depression and facilitates treatment will be more effective in alleviating these symptoms than a strategy based on providing feedback on the presence of these symptoms and treatment algorithms to renal providers.

Specific Aim 2: To compare the impact of two strategies for the treatment of pain, sexual dysfunction and depression on quality of life and satisfaction with care in hemodialysis patients.
Hypothesis: A symptom management strategy in which a trained nurse identifies the presence of pain, sexual dysfunction, and depression and facilitates treatment will lead to greater improvement in quality of life and satisfaction with care than a strategy based on providing feedback on the presence of these symptoms and treatment algorithms to renal providers.

Specific Aim 3: To compare the impact of two strategies for the treatment of pain, sexual dysfunction, and depression on compliance with dialysis therapy, emergency room visits, and hospitalizations in patients receiving hemodialysis.
Hypothesis: A symptom management strategy in which a trained nurse identifies the presence of pain, sexual dysfunction, and depression and facilitates treatment will result in greater compliance with dialysis therapy and fewer emergency room visits and hospitalizations than a strategy based on providing feedback on the presence of these symptoms and treatment algorithms to renal providers. This hypothesis is borne out of the observation that depression is associated with an increased risk for hospitalization and mortality, and that these associations may be mediated by non-compliance with dialysis.

METHODS:
In a randomized clinical trial of 288 patients receiving hemodialysis at 9 dialysis units, two symptom management strategies were compared: (a) providing feedback on patients' symptoms to renal providers along with evidence-based algorithms for their treatment; and (b) using a trained nurse to identify and facilitate treatment of these symptoms.

After enrollment, baseline data were collected from all patients during a 2-12 month observation period. Pain, sexual dysfunction, and depression were assessed monthly, and quality of life was assessed quarterly, using validated questionnaires. We also assessed satisfaction with care on a quarterly basis. Our assessment of sexual function focused on erectile dysfunction in men, and decreased libido, arousal, dyspareunia, and satisfaction in women. We also conducted monthly assessments of patients' attendance at dialysis, compliance with treatment duration, emergency room visits, and hospitalizations.

After the observational phase, we launched a 12-month intervention phase to compare two interventions, during which we continued monthly assessments of pain, sexual dysfunction, and depression, and quarterly assessment of quality of life and satisfaction with care. Patients were randomized into one of two arms based on their dialysis shift. In the "feedback" arm, renal providers received data on patients' pain, sexual dysfunction, and depression along with algorithms for the treatment of these symptoms. (For sexual dysfunction, providers received a treatment algorithm for erectile dysfunction and a recommendation to refer women for gynecologic care.) Treatment decisions were left at the discretion of the provider(s). In the "nurse management" arm, a trained nurse assessed and facilitated the treatment of pain, sexual dysfunction, and depression. In this arm, treatment of sexual dysfunction in men focused on erectile dysfunction, while the nurse facilitated referral of women with sexual dysfunction for gynecological care, given the lack of efficacious pharmacologic therapy for women. We tracked attendance and compliance with dialysis, emergency room visits, and hospitalizations on a monthly basis during the intervention phase.

FINDINGS/RESULTS:
We enrolled and collected baseline data on 289 patients. Patients' mean age was 63 years and median time on dialysis was 2 years; 56% of patients were male, 56% White, and 39% African-American.

Upon completion of the observational phase, 220 patients were randomized: 120 to Feedback and 100 to Nurse Management.

Specific aim 1: Compared to the Feedback arm, patients in the Nurse Management arm did not experience reductions in pain (B=0.33, p=0.48), erectile dysfunction (B=0.18, p=0.62), or depression (B=0.11, p=0.64). Compared to their symptoms during the observational phase, patients in the Nurse Management arm experienced small improvements in erectile dysfunction (B=-0.78, p=0.02) and depression (B=-1.04, p=0.04), while patients in the Feedback arm experienced small improvements in pain (B=-0.98, p<0.0012), erectile dysfunction (B=-0.98, p<0.001), and depression (B=-1.36, p=0.001).

Specific aim 2: We do not observe greater improvement in the quality of life or satisfaction with care among patients in the Nurse Management arm compared to the Feedback arm, (B=-0.2, p=0.22) and (OR=1.5, p= 0.21) respectively.

Specific aim 3: Patients in the Nurse Management arm had significantly more missed (IRR=3.0, p<.001) and abbreviated (IRR=1.5, p=0.01) dialysis sessions compared to the Feedback arm, with no differences between the interventions in the number of emergency room visits (IRR=1.3, p=0.18) or hospitalizations (IIR= 0.8, p=0.27).

IMPACT:
This study found that both symptom management strategies resulted in small improvements in symptoms (compared to usual care delivered in the observational phase), but a nurse management strategy did not improve symptoms to a greater degree than providing symptom data to renal providers. These findings will inform future strategies to increase provider recognition and treatment of symptoms in this chronically ill patient population.

PUBLICATIONS:

Journal Articles

  1. Tohme F, Mor MK, Pena-Polanco J, Green JA, Fine MJ, Palevsky PM, Weisbord SD. Predictors and outcomes of non-adherence in patients receiving maintenance hemodialysis. International urology and nephrology. 2017 Aug 1; 49(8):1471-1479.
  2. Pena-Polanco JE, Mor MK, Tohme FA, Fine MJ, Palevsky PM, Weisbord SD. Acceptance of Antidepressant Treatment by Patients on Hemodialysis and Their Renal Providers. Clinical journal of the American Society of Nephrology : CJASN. 2017 Feb 7; 12(2):298-303.
  3. Belayev LY, Mor MK, Sevick MA, Shields AM, Rollman BL, Palevsky PM, Arnold RM, Fine MJ, Weisbord SD. Longitudinal associations of depressive symptoms and pain with quality of life in patients receiving chronic hemodialysis. Hemodialysis international. International Symposium on Home Hemodialysis. 2015 Apr 1; 19(2):216-24.
  4. Weisbord SD, Mor MK, Sevick MA, Shields AM, Rollman BL, Palevsky PM, Arnold RM, Green JA, Fine MJ. Associations of depressive symptoms and pain with dialysis adherence, health resource utilization, and mortality in patients receiving chronic hemodialysis. Clinical journal of the American Society of Nephrology : CJASN. 2014 Sep 5; 9(9):1594-602.
  5. Mor MK, Sevick MA, Shields AM, Green JA, Palevsky PM, Arnold RM, Fine MJ, Weisbord SD. Sexual function, activity, and satisfaction among women receiving maintenance hemodialysis. Clinical journal of the American Society of Nephrology : CJASN. 2014 Jan 1; 9(1):128-34.
  6. Green JA, Mor MK, Shields AM, Sevick MA, Arnold RM, Palevsky PM, Fine MJ, Weisbord SD. Associations of health literacy with dialysis adherence and health resource utilization in patients receiving maintenance hemodialysis. American journal of kidney diseases : the official journal of the National Kidney Foundation. 2013 Jul 1; 62(1):73-80.
  7. Weisbord SD. Sexual dysfunction and quality of life in patients on maintenance dialysis. Seminars in Dialysis. 2013 May 1; 26(3):278-80.
  8. Weisbord SD, Mor MK, Green JA, Sevick MA, Shields AM, Zhao X, Rollman BL, Palevsky PM, Arnold RM, Fine MJ. Comparison of symptom management strategies for pain, erectile dysfunction, and depression in patients receiving chronic hemodialysis: a cluster randomized effectiveness trial. Clinical journal of the American Society of Nephrology : CJASN. 2013 Jan 1; 8(1):90-9.
  9. Green JA, Mor MK, Shields AM, Sevik MA, Palevsky PM, Fine MJ, Arnold RM, Weisbord SD. Renal provider perceptions and practice patterns regarding the management of pain, sexual dysfunction, and depression in hemodialysis patients. Journal of palliative medicine. 2012 Feb 1; 15(2):163-7.
  10. Green JA, Mor MK, Shields AM, Sevick MA, Palevsky PM, Fine MJ, Arnold RM, Weisbord SD. Prevalence and demographic and clinical associations of health literacy in patients on maintenance hemodialysis. Clinical journal of the American Society of Nephrology : CJASN. 2011 Jun 1; 6(6):1354-60.
  11. Weisbord SD, Shields AM, Mor MK, Sevick MA, Homer M, Peternel J, Porter P, Rollman BL, Palevsky PM, Arnold RM, Fine MJ. Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study. Contemporary clinical trials. 2010 Sep 1; 31(5):491-7.
Journal Other

  1. Belayev LY, Mor MK, Palevsky PM, Arnold RM, Weisbord SD. Associations of depression and pain with quality of life and satisfaction in chronic hemodialysis patients. [Abstract]. Journal of the American Society of Nephrology : JASN. 2014 Nov 1; 25:944A.
  2. Weisbord SD. Female sexual dysfunction in ESRD: an underappreciated epidemic? Clinical Journal of the American Society of Nephrology. 2012 Jun 1; 7(6):881-3.
VA Cyberseminars

  1. Weisbord SD. Assessment and management of symptom in patients on dialysis. [Cyberseminar]. 2010 Mar 24.
Conference Presentations

  1. Green J, Mor MK, Shields A, Sevick MA, Arnold RM, Palevsky PM, Fine MJ, Weisbord SD. Health literacy and outcomes in hemodialysis patients. Poster session presented at: American Society of Nephrology Renal Week Annual Meeting; 2011 Nov 10; Philadelphia, PA.
  2. Weisbord SD. Quality of life in ESRD patients: the burden and role of physical symptoms. Paper presented at: National Kidney Foundation Clinical Spring Meeting; 2010 Apr 14; Orlando, FL.
  3. Green J, Mor MK, Shields A, Porter P, Palevsky P, Fine MJ, Arnold RM, Weisbord SD. Health literacy in hemodialysis patients. Poster session presented at: American Society of Nephrology Renal Week Annual Meeting; 2009 Oct 30; San Diego, CA.


DRA: Health Systems, Mental, Cognitive and Behavioral Disorders, Kidney Disorders
DRE: Diagnosis, Treatment - Observational, Treatment - Comparative Effectiveness
Keywords: Chronic disease (other & unspecified), Depression, Pain
MeSH Terms: none

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