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A behavioral skills training eased pain for people on hemodialysis, with benefits for pain interference, quality of life, and other patient-reported outcomes.

Behavioral pain coping skills training (PCST) eases pain for people on hemodialysis, results from the HOPE Consortium clinical trial suggest.

“PCST showed benefits on pain interference, quality of life, and several other [patient-reported outcomes (PROs)] among individuals undergoing maintenance hemodialysis and experiencing chronic pain,” researchers wrote in JAMA Internal Medicine. “While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants.”

PCST may provide a low-risk and accessible approach for people with dialysis-dependent kidney failure, “a population with limited options for managing pain,” Laura M. Dember, MD, and colleagues wrote.

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The researchers enrolled 643 adults with chronic pain who were undergoing maintenance hemodialysis at 16 academic centers and 103 outpatient dialysis facilities in the US (mean age, 60.3 years; 55.2% men). Nearly half of the study population (n=308; 47.9%) was Black, and more than half of all patients (n=380; 59.2%) had diabetes.

In total, 319 patients were randomly assigned to PCST and 324 to usual care. At the baseline visit, participants in both groups were given an educational brochure about chronic pain, and they received the same care for pain and other conditions they would receive outside trial participation. Patients in the PCST group took part in 12 weekly coach-led video or phone sessions on issues including anxiety, stress, sleep, pain, and coping skills, followed by 12 weeks of daily automated interactive telephone voice response sessions. By contrast, patients in the usual care group received no trial-driven pain intervention.

Participants were followed through 36 weeks and were assessed every 4 weeks for adverse events and clinical outcomes. Medication records were also updated, and outcome-related calls were scheduled during these assessments.

Dr. Dember and colleagues reported the following outcomes:

• At 12 weeks, the researchers found a modest, but statistically significant, beneficial effect of PCST compared with usual care on pain interference as measured by the Brief Pain Inventory (BPI) Interference subscale (between-group difference, -0.49; 95% CI, -0.85 to -0.12; P=0.009).
• At 24 weeks, the difference persisted (between-group difference in BPI Interference score, -0.48; 95% CI, -0.86 to -0.11) but decreased at week 36 (between-group difference in BPI Interference score, -0.34; 95% CI, -0.72 to 0.04).
• At 12 weeks, a BPI Interference score decrease of more than one point (minimal clinically important difference) occurred in 143 (50.9%) of 281 participants in the PCST group versus 108 (36.6%) of 295 participants in the usual care group (odds ratio, 1.79; 95% CI, 1.28-2.49).
• At 24 weeks, a BPI Interference score decrease of more than one point occurred in 142 (55.0%) of 258 participants in the PCST group versus 113 (42.8%) of 264 in the usual care group (odds ratio, 1.59; 95% CI, 1.13-2.24).

At week 24, patients taking part in PCST also showed greater improvements in secondary outcomes, including:

• Pain intensity: mean 0-to-10-point BPI Severity scale between-group difference -0.50 points (95% CI, -0.85 to -0.16);
  • Pain catastrophizing: mean 0-to-24-point, 6-item Pain Catastrophizing Scale short form between-group difference -1.49 points (95% CI, -2.46 to -0.52);
  • Depression: mean 0-to-27-point, 9-item Patient Health Questionnaire between-group difference -0.94-points (95% CI, -1.82 to -0.06);
  • Anxiety: mean 0-to-21-point, 7-item Generalized Anxiety Disorder scale between-group difference -0.98-points (95% CI, -1.84 to -0.13).
  • Quality of life: 0-to-10-point, single-item score between-group difference 0.40 (−0.09 to 0.89)

Bernard G. Jaar, MD, MPH, a nephrologist who was not involved in the study, talked with Physician’s Weekly (PW) about its results and the potential for incorporating PCST into patient care.

PW: What are the study’s most important findings?

Bernard G. Jaar, MD, MPH: This is a groundbreaking study for this vulnerable population with several comorbidities and a high pain burden that is generally difficult to treat, in part due to altered pharmacokinetics and possible interactions with a large number of other daily medications. The PCST training was feasible as it was mostly administered in dialysis centers while patients were undergoing hemodialysis. The PCST training was clinically effective, with improvement in pain interference and benefits in areas typically difficult to manage, such as anxiety, depression, and quality of life.

Did the results surprise you?

Yes, they did, a bit, not only because of the persistent long-term benefit in pain interference, but also—and more significantly—due to the unexpected benefits in other challenging symptoms to treat, such as anxiety, depression, and quality of life. All these important issues are difficult to manage in our dialysis population.

Why was it important to do this study?

This was a very important study to conduct because we have had a very difficult time managing chronic pain in our dialysis population, with limited evidence-based data on the medical and pharmaceutical management of their chronic pain. The findings of this study open the door to new, effective, and feasible pain management options.

How might the findings impact patient care?

The results provide evidence for a new cognitive behavioral intervention for chronic pain management among in-center hemodialysis patients. However, implementing these findings may be more challenging, not because of patients’ or providers’ acceptance, but because of needing to find the experts to deliver the PCST and convincing payers to support this treatment. Currently, it remains unclear if this type of management is cost-effective in our dialysis population.

Are any strengths or limitations especially noteworthy?

As the authors outlined, the study has many strengths, including its multicenter design involving more than 100 dialysis centers and a very diverse population. However, it remains unclear how these findings can be generalized in patients aged older than 80 years or in populations outside the US with different care delivery systems, cultures, and so forth.

What questions remain unanswered for you?

At this point, a couple of important questions remain, starting with the cost-effectiveness of this intervention and how we can work with different stakeholders, particularly payers, to implement it. An equally important question is how to identify the professionals who will need to be trained to deliver this intervention most effectively at the chairside during hemodialysis. Our social workers are already stretched to the limit, and adding this intervention to their workload may be a very challenging barrier.

However, there is hope for the management of our dialysis patients’ chronic pain. Keep an open mind and think “outside the box” with behavioral therapy. It would be good to replicate and confirm these findings in other populations. We need to continue to organize and work with our professional societies, and to engage and network with our policymakers, to deliver improved care to this vulnerable patient population.