Telephone follow-ups improve virologic outcomes
Program could be worked into regular budget
A study shows that telephone interventions led by pharmacists result in improved viral load suppression over usual care.
Investigators worked with an indigent population at a Southeastern clinic that was well-known for adherence issues, says Heather L. Cox, PharmD, BCPS, pharmacy clinical specialist in infectious diseases at the University of Virginia Health System, department medical center - pharmacy in Charlottesville, VA.
They designed a simple intervention that would have pharmacists call patients to discuss their HIV medication adherence and side effects.
"By the six-month clinic visit, 53 percent of the phone call group and 26 percent of the standard-of-care group had achieved undetectable viral loads," Cox says.
The population was at risk for adherence problems because of socioeconomic issues. Investigators screened 123 patients for the study, but excluded 62, including 34 percent because they declined to participate and 32 percent because of lacking a telephone.1
The study was designed to be an intervention that would work in any HIV clinic, using existing resources, says Aimee Wilkin, MD, MPH, AAHIVS, assistant professor in the section on infectious diseases, Wake Forest University Health Sciences (WFUHS) of Winston-Salem, NC.
"We did this without any funding, and worked it into our clinic's programs," Wilkin says. "What motivated us from our clinical perspective was to come up with a simple intervention to improve adherence in a busy, Title III Ryan White-funded clinic."
The Infectious Diseases Specialty Clinic, operated by WFUHS, has a population that is 75 percent African American, 36 percent female, 40 percent uninsured, and 35 percent Medicaid, Wilkin says.
The clinic typically has at least five people starting medications in a week, with maybe a caseload of 20 to 30 at any given time, Wilkin says.
"The key is there are some lovely adherence interventions you can read about, and they have multidisciplinary groups and beepers and those sorts of things," Wilkin says. "But without funding, it's very difficult to implement those — so this was an effort to find something that fits into existing clinic work flow."
The intervention had pharmacists call patients once a month between the monthly clinic visits, although the first calls took place within two or three days of the first clinic visit, Cox says.
The second call was at the two-week mark when it was assumed the patient had picked up his or her medications and could now talk intelligently about how he or she was doing, Cox says.
The end point was when the patient's viral load became undetectable, or at the six-month visit.
"Most of those who declined didn't want us calling them at work," Cox says.
Lack of access to a telephone remained a barrier throughout the study, she adds.
"Obviously, it would be nice to figure out how to expand the intervention to patients who don't have phones readily available, but we haven't figured out that one yet," Wilkin says.
In the study's informed consent, researchers asked participants to identify who the pharmacists could call and talk to and what they could say in answer to questions, Cox notes.
"Our primary end points included adherence, change in CD4 count, and virologic outcomes, as defined by a log change in viral load and proportion of patients who achieved undetectable viral load at follow-up," Cox says. "One thing we found that was no big surprise is that adherence is extraordinarily difficult to measure."
Also, investigators found that participants had difficulty adhering to clinic visits, as well as to their medication regimens, Cox says.
"People didn't show up for appointments, and that opens the door to people falling out of care," Cox says.
One of the intervention's limitations was that it relied on three pharmacists who were trained in infectious diseases and who were not exclusively employed by the HIV clinic, Cox notes.
"We all rotated between that clinic," Cox says. "I think this intervention is best applied by a clinic that has a dedicated pharmacist because it takes a lot of time out of your day."
For example, the pharmacists had difficulty getting participants on the telephone, and they couldn't leave messages. So they made repeated calls, she says.
Also, they frequently encountered canceled cell phone services and changed numbers, Cox adds.
While having an assistant initiate the calls and track down clients might work, it would have problems of its own, such as confidentiality, privacy issues and staffing conflicts, Cox notes.
However, the intervention is being modified to use phone triage nurses, who could work the phone calls into their routine of handling patient calls and issues, Wilkin says.
The clinic currently has one triage nurse, and another one will be hired, she adds.
"One of our practical limitations once the project was done is reworking things so we have the personnel time to implement the intervention on a large scale," Wilkin says.
"In our particular situation, we used pharmacists who were available part time in the clinic," Wilkin says. "I think it could be done with nurses or other available clinic staff, and each setting would have an array of people who would be available for it."
Here are the questions the pharmacists would ask:
- How are you taking your medications?
- How many times a day do you take the blue one? Cox says the questions have to be posed in terms of the pill's color because the patients often didn't know the names of their medications.
- How many times do you take the big orange one?
- Where do you store your pills? When patients had difficulty answering these first questions, it was a signal to the pharmacist that the patient was not taking the medications as prescribed, Cox notes.
- How many doses do you think you had to miss last week?
- How many doses did you lose? Questions about doses were asked in a way that would help the patient feel more at ease in admitting missed doses, Cox says.
Pharmacists also would inquire about adverse events, and provide interventions and referrals when necessary.
For example, one patient was taking Abacavir and had a hypersensitivity reaction that was potentially life threatening. The pharmacist told the patient to stop taking the medication, and had the patient return to the clinic for an evaluation and new prescription, Cox says.
"One patient was on an opportunistic infection (OI) prophylaxis, and we felt it was time to reverse that," Cox says. "Another was not taking an OI and needed it."
For patients who were doing well, the pharmacist call might last five minutes. For others, it could last 40 minutes, Cox says.
"This wasn't a cheap intervention because of the trouble getting hold of patients," Cox notes.
However, the intervention was designed to work in a real world setting with patients who typically have difficulty with adherence, Cox says.
"There were certainly patients we called on the phone where we made important interventions," Cox says. "Whether another center would find the same results remains to be seen, but I would imagine it would only prove helpful."
When the intervention is modified using triage nurses, it would include back-up by physicians or clinicians. Also, the triage nurses are trained in handling adverse events and other medication problems, Wilkin says.
"Pharmacists would still be involved, doing the initial counseling for patients when they start new regimens," Wilkin says. "They do usually see people at follow-up visits, and they would be available also to provide back-up for the triage nurses."
- Cox HL, et al. Clinician-Initiated Telephone Follow-Up Improves Virologic Outcomes in an HIV Outpatient Clinic. Presented at the XVI International AIDS Conference, held Aug. 13-18, 2006, in Toronto, Canada. Available at www.iasociety.org.