For years, Tully managed her pain with very low doses of opioid drugs. But when her chronic pain began to worsen in 2000, she visited multiple pain clinics seeking solutions, repeatedly increasing her dose of opioids. She ended up taking oxycodone, a strong opioid, in a dose far greater than the level that should trigger caution, according to 2016 Centers for Disease Control and Prevention (CDC) guidelines.

“By June 2001, I was a total zombie,” Tully says. “I’d worked all my life. I’d been an elected official in my hometown. I’d owned businesses. But now, I was someone walking around the house in a robe, not able to drive, not able to think, not able to do anything.”

She spent years recovering from medically induced addiction and learning to manage her pain without opioids. Now, she’s a patient partner on a PCORI-funded study that compares outcomes at pain clinics that either have or haven’t implemented an opioid risk–reduction program. Early results show that the program has been successful: it decreased patients’ average opioid dose.

PCORI’s research portfolio tackles the challenge of chronic pain on many fronts. PCORI has funded 49 comparative clinical effectiveness studies addressing chronic noncancer pain management or opioid use. Fifteen focus on use of opioids in treating chronic pain, and three others assess opioid use in the context of substance abuse.

“Chronic pain is one of the biggest conundrums facing medicine,” says Michael Von Korff, ScD, an epidemiologist and health-services researcher at Group Health Cooperative in Seattle, which has recently become part of Kaiser Permanente and changed its name to Kaiser Permanente Washington. He leads the PCORI-funded study of the opioid risk–reduction program in clinics. “We had an important opportunity to see whether a health system initiative could help patients in pain without overrelying on opioids.”

Worth the Risks?

Opioids, taken as prescribed, can help control some short-term pain, but there’s disagreement about whether they work over the long run and, if they do, whether their benefits outweigh the risk of addiction. "There aren't any long-term studies to tell you whether opioid use is safe and effective for chronic pain," says Von Korff. “But the practice of prescribing them took off. By 2014, 3 percent of all US adults were receiving long-term opioid therapy.”

This extensive prescribing of opioids has contributed to an alarming rise in inappropriate use, outright abuse, and overdose. Since 1999, prescription-opioid sales have quadrupled, according to CDC. And, in 2015, opioid overdoses caused 33,000 deaths.

For many years, Von Korff had studied the risks of prescription opioid use. His and others’ research suggested that chronic pain patients using prescribed opioids were risking overdose. What’s more, his research indicated that higher doses increased overdose risk.

In 2010, Group Health started a risk-reduction initiative to lower the highest opioid doses among its patients, while more closely following all its patients on opioids. The initiative also included individualized care plans created by physicians and patients, along with a requirement that each patient get opioid prescriptions from only one physician.

In addition to the clinics it runs, Group Health contracts for patient care at outside clinics, where the risk-reduction program isn’t required. Von Korff realized that by comparing treatment at Group Health and the outside clinics, he had the perfect opportunity for a natural experiment on the initiatives’ impact. “We want to find out whether our program is the right response to the opioids problem,” he says.

So with PCORI funding, he started the study, with Tully and eight other patients with diverse perspectives and experiences as advisors, to compare health outcomes among 1,600 patients using opioids long term. Outcomes measured include patients’ ratings of their pain and psychological well-being, and their perceptions of opioids’ benefits and risks.

The researchers are also studying electronic health records—from 2006 to 2014—of 33,000 long-term opioid users. The team will assess the risk-reduction initiative’s impact on opioid-related problems, including overdose and car accidents.

The study is ongoing, but initial results show that the average daily opioid dose declined more at Group Health clinics than at the clinics without the initiative. What’s more, the fraction of patients being treated for pain taking daily doses of more than 120 milligrams of morphine or its equivalent fell more dramatically at Group Health than at the other clinics, the team reported in 2016.

Not all the measures showed a difference, however. Last November, the researchers reported no difference in motor vehicle crashes when comparing patients taking chronic opioids from Group Health clinics and clinics without the initiative.

A Right to Science-Based Treatments

After her recovery, Tully became concerned about overprescription nationwide. “Patients have a right to safe, effective, and science-based treatments,” she says. She teamed up with a doctor to form the advocacy group Physicians for Responsible Opioid Prescribing. Through that group, she met Von Korff.

Tully and the other patient advisors helped select what the study measures. “For injuries, we were originally going to look just at hip and pelvis fractures,” Von Korff says. “But our patient advisory committee said, ‘We know people who have had falls, and you should be looking at a much broader range of injuries, like twisted ankles or concussions.’ We dramatically expanded the range of injuries we’re looking at.”

Patient advisors’ diverse experiences have helped throughout the study. “Opioid use is a very controversial area, so different patients have different points of view,” Von Korff says. “There isn’t a patient point of view.”

Tully agrees. She now takes no opioids but, she says, “there are some patients advising the project who struggle, saying, ‘If you took my pain meds away, I’d be in bed crying all day.’”

Another patient, Max Sokolnicki, says that the advisors have provided “very, very honest opinions,” and he’s glad the researchers are listening. Sokolnicki developed chronic foot pain in 2002 after a hip replacement damaged a nerve. He’s taken strong opioids but disliked the side effects. Now, he uses a spinal cord stimulator, a device that sends mild electric current to the spine, to manage his day-to-day pain. He saves strong opioids for his occasionally more serious pain.

Regardless of their individual experiences, Tully says, the patient advisors agree that the study is powerfully important. She emphasizes the lack of available research to inform evidence-based practice. “You have to know what you’re dealing with and be aware of the risks, as well as the benefits, of opioids,” she says.

Posted: May 9, 2017