'Express care', a new model for providing care to people starting antiretroviral therapy in which most of the burden for seeing patients is shifted to nurses, is associated with reduced death rates (by about 50%) and reduced losses to follow-up among people with CD4 cell counts of less than 100 cells/mm3, according to a Kenyan presentation made earlier this month at the International AIDS Conference, in Mexico City.
In addition, providing ‘express care’ for both stable and high-risk patients on antiretroviral therapy reduces clients' waiting time, leads to less congestion in clinics and gives clinicians more time to manage ill patients, according to another report at the conference.
The programme, which was first piloted by the USAID-AMPATH partnership at a few high-volume clinics in Western Kenya, was so successful that it has now been rolled out to all 18 of the AMPATH clinics.
AMPATH’s evolving patient care model
“Many people still present for care in advanced stages of disease, which of course, leads to poorer prognosis,” said Dr Paula Braitstein of AMPATH, who gave one of the presentations, “and the ART-LINC collaborative study identified that the highest risk period for mortality in people from resource-limited settings is in the first three months after going on ART.”
AMPATH’s initial care model was heavily dependent upon clinical officers (upper/middle cadre health workers) who are supervised by a physician. Clients who are not yet on antiretroviral therapy are asked to attend the clinic every one to six months. But after starting antiretroviral therapy, AMPATH required patients to come in two weeks after starting treatment and then monthly thereafter. Note, this is much more frequent contact between the patient and clinic than in many antiretroviral programmes in resource-limited settings, which commonly see patients quarterly.
But AMPATH had data of its own suggesting that even monthly contact was not enough for patients starting antiretroviral therapy with more advanced HIV.
“A study was done in AMPATH that showed that patients with CD4 counts below 100 had a high mortality in the first 3 months after start of cART. This was attributed to IRIS and mainly pulmonary TB,” said Dr Rose Kosgei, also of AMPATH, who gave the other presentation on express care. “Due to this finding the programme decided that this group of patients should be seen weekly for the first 3 months after start of cART.”
But the programme’s resources were already strained “by two patient groups, clinically stable patients… and high-risk patients,” she said.
The clinically stable patients had minimal need for clinician intervention but had to queue for hours to see the clinician just to get their drug refills; meanwhile, the patients with a ‘high risk’ of poor prognosis required a lot of clinician time.
So AMPATH piloted the express care project in March 2007, with two aims “to reduce mortality in HIV-infected adults with CD4 cell counts ≤ 100 initiating ART; and to increase clinic capacity without increasing costs,” said Dr Braitstein.
To do this, the project shifted some of the burden of care to nurses — and streamlined clinic visits.
The programme defines ‘stable’ patients as adults on antiretroviral therapy for more than six months, with CD4 cell counts over 200 cells/mm3, no opportunistic infections or chronic illness, and with a record of perfect adherence to their medication and clinic visits. Upon meeting these criteria, the clinician gives the patient their usual one-month supply of antiretrovirals and refers them to express care. These clinically stable patients are still asked to come in for monthly express care visits with the nurse, only meeting with the clinical officer every third month unless a consultation is requested. The clinical officer is primarily responsible for diagnosing toxicity, intercurrent illnesses, or treatment failure. During the express care visits, the nurse quickly screens the patient with a ‘brief encounter form’, and makes referrals when necessary. The encounter forms have minimal charting demands and no vital signs are taken. The emphasis is on adherence support, drug refills and lab requests if required as per the referral form.
“The patient is supposed to be out of there within five minutes,” said Dr Braitstein. “The encounter form is one quick page. The whole idea is that it is really straightforward and fast. But if there is any clinical indication, for example, if they have a fever or rash, they are just sent immediately to see a clinical officer.”
However, express care also requires closer contact for the most ill ‘high-risk’ patients. These are defined as any adult with less than 100 CD4 cells/mm3 — and thus at high risk of death or of dropping out of clinic care. After the patient gets their first supply of antiretrovirals, they still have to see the clinical officer two weeks later and then monthly thereafter for refills for the first three months after starting antiretroviral therapy.
But in between each visit with the clinical officer, they are required to either come into the clinic to see the nurse, or be in contact with the nurse by telephone. These express care visits are somewhat more structured than with the stable patients. The nurse assesses adherence, checks the patient’s vital signs and conducts a rapid symptom assessment (for new cough for more than 3 weeks, breathlessness, rash, yellowing of eyes, vomiting, diarrhoea, severe headache and fever), referring anyone who is ill or poorly adherent to the clinical officer. In most cases, the visits will still be brief.
Assessing the impact of express care in high risk patients
Dr Braitstein reported on a retrospective analysis to determine whether express care reduced early mortality and losses to follow-up (defined as being absent from the clinic for at least three months) among the subset of ‘high-risk’ patients compared to routine care.
During the pilot period, 4824 patients were seen; 90% qualified for express care, though, notably, only 35% of those who were eligible were referred into the programme. Dr Braistein believes this was because “it takes a while for clinicians to remember and/or feel comfortable using new protocols such as express care.”
Kaplan Meier methods were used to calculate time to events and the probability of remaining alive and in care. Incidence rates (IR), adjusted hazard ratios (AHR), and 95% confidence intervals (CI) per 100 person-months (PM) of follow-up, were calculated and the adjusted effect of express care was modelled with Cox regression.
2601 eligible patients were included in the study, with 14.6% given express care. The remainder received routine care of monthly clinic visits.
The median age, gender, baseline CD4 cell count, WHO stage and TB treatment status when starting antiretroviral therapy were similar for the high-risk patients in express care and those who received routine care; however significantly more subjects in high-risk care attended urban clinics (68% vs 46%, p
There were 348 events, including 156 deaths over 11,464 person-months of follow-up; 8.5% were receiving express care compared with 14.3% in routine care. The probability of remaining alive was significantly higher for those in express care throughout the study period (log rank p=0.009) — though the biggest differences were seen somewhere around the first month and a half after initiating antiretroviral therapy. Likewise, the probability of remaining alive and in care was significantly higher for those in express care (log rank p=0.001).
However, there were concerns about selection bias because of how the pilot clinics were selected and because only about half of the patients who qualified "actually made it into express care," said Dr Braitstein.
So a sub-analysis was performed restricted to the patients who qualified for express care and who started antiretroviral therapy at the pilot sites during the period that express care was piloted. The association with better outcomes for those in express care seemed even stronger.
Express Care | Routine Care | Total | |
N | 336 | 379 | 715 |
Total N Events | 31 | 57 | 88 |
Months of follow-up | Median 5.3 | Median 3.8 | 3598 |
N deaths | 12 | 30 | 42 |
N Loss to Follow Up | 19 | 27 | 48 |
The probability of remaining alive stayed significantly higher for those in express care throughout the study period (log rank p=0.003) and the probability of remaining alive and in care was significantly higher for those in express care (log rank p=0.03). Despite the subset analysis, a significantly larger percentage of subjects in express care were still seen at urban clinics (66% vs 53%, p
Further analysis, adjusted for CD4 count closest to treatment initiation, WHO clinical stage, gender, age, clinic location, cotrimoxazole use or being on TB treatment at the start of antiretroviral therapy, confirmed a 50% reduced risk of death in the complete cohort from receiving express care (the adjusted hazard ratio was 0.54, 95% CI 0.31-0.94) and a reduced risk of death or loss to follow-up (0.58, 95% CI 0.40-0.84). The effect was similar in the restricted subset, though the confidence intervals crossed once: for death, the adjusted hazard ratio was 0.55, (95% CI 0.25-1.20), and for death or loss to follow-up, the adjusted hazard ratio was 0.80 (95% CI 0.47-1.35).
Other key factors
Dr Braitstein stressed that the observational nature of the data limits what conclusions can be drawn. For instance, “clinicians and nurses who refer to and/or work in EC may be better trained in and/or more attentive to clinical protocols and patient care,” she said.
Another possibility is that the clinician may have been less likely to refer those people who complained about coming in for more frequent visits (due to travel expense or time). But Dr Braitstein does not believe this is an issue because the patient characteristics appeared virtually identical between those who were referred for express care at each clinic and those who were not. Notably, the programme offers some subsidies to offset travel costs for some patients.
It seems more than likely that the more intensive contact with the ‘high-risk’ patients led to earlier identification and management of symptoms (whether from immune reconstitution syndrome or other causes) and thus improved outcomes. Furthermore, the nurse-centred express care was a more efficient model of care, with express care for stable patients freeing up programme space, time and resources.
“Patient queues shortened markedly,” said Dr Kosgei. “Staff and patients liked express care. Nurses were comfortable with task shifting and their motivation improved due to the increased responsibilities. Finally, clinicians had more time available to devote to the sicker patients.”
Kosgei RM et al. Express Care: A clinician–nurse model for the management of high volume HIV clinics in western Kenya. 17th International AIDS Conference, Mexico City, abstract WEAX0102, 2008