CADRES Trial—Tempering Agitation by Non-pharmacological Means
Agitation is one of the most difficult symptoms of dementia for patients and caregivers to deal with. Patients who become aggressively agitated are often treated with antipsychotic drugs, despite evidence that such treatment has limited efficacy and carries the risk of serious side effects, including increased mortality (see ARF related news story). It may come as welcome news, then, that there are non-pharmacological interventions that can help. In this week’s Lancet Neurology online, researchers led by Lynn Chenoweth at the University of Technology Sydney, Australia, report the results of CADRES, the Caring for Aged Dementia Care Resident Study, a clinical trial to test the value of holistic, person-centered care regimens in caring for dementia patients. The trial results add weight to the idea that tailored, more personalized care can significantly reduce agitation in people with dementia.
CADRES is a cluster-randomized clinical trial, in which 15 residential care sites were randomly assigned to adopt one of three care regimens: usual care, person-centered care, and dementia-care mapping. Person-centered care and dementia-care mapping put the patient first. “The idea comes from the Kitwood theoretical proposition that if you ensure that the environment, and all of the factors within, is person-centered in all its dimensions, then that person will be better receptive to the stimulus that’s there,” said Chenoweth in an interview with ARF. It means that patients will be able to take in what is going on around them and not get stressed. In practice this involves removing what Tom Kitwood at the University of Bradford called “malignant social psychology,” examples of which include labeling, disempowerment, objectification, and infantilization, which can be deeply demoralizing to patients (see Kitwood T. The experience of dementia. Aging Ment Health 1997; 1:13-22). “You hold the patient in high regard and treat them as a human being,” said Chenoweth. “When staff bring around a meal, if the patient shoves it away, you gently try to find out are they are hungry or if there is something about the meal they don’t like,” she said. It requires not doing anything that causes resistance or distress. But too often care staff are not communicating with these patients very well, suggested Chenoweth. “They are not explaining or asking permission, they are marginalizing patients in many different ways,” she said. “Staff don’t do it deliberately. They don’t know how to communicate properly or how to be therapeutic in how they do it,” she said.
In CADRES Chenoweth and colleagues trained care staff in two versions of person-centered care at five sites each. The remaining five sites continued care as usual. In total, 289 patients were covered in the trial. Patients had to be over 60, have a diagnosis of dementia, and had behavioral and psychological symptoms of dementia. “We made sure that all of the residents were similar in situation, ability, and level of dependency,” said Chenoweth. Ninety-eight patients received person-centered care and 109 dementia-care mapping. In the former, selected site staff underwent two days’ training with researchers qualified in teaching person-centered care. The training included a review of current practices and implementation of person-centered approaches, with an emphasis on social interactions that engage patients. For dementia-care mapping, researchers trained in this type of care observed how staff interacted with patients over a two-day period and then instructed staff on person-centered care implementation. “Mapping and person-centered care use the same principle, but in the mapping process the mappers are the ones who decide how things should be in terms of improvement, whereas in person-centered care it is the care staff themselves,” said Chenoweth.
The initial two days’ training was followed by a four-month intervention period during which the trained staff helped their colleagues implement the new care system. Phone support was provided by Chenoweth and colleagues. There was also a further four-month follow-up without expert support. Primary outcome—agitation measured with the Cohen-Mansfield agitation inventory (CMAI)—was measured at baseline, at four months, and after the four-month follow-up. Secondary outcomes measured in parallel included neuropsychological test battery, quality of life, falls, and cost of treatment.
The researchers found that after both the initial four-month intervention and the four-month follow-up, patients who received either person-centered care or dementia-care mapping had a significantly lower CMAI score than those receiving usual care. “The improvements in agitation are extremely encouraging and emphasize the importance of further trials with dementia-care mapping,” write Clive Ballard and Dag Aarsland, King’s College London, in an accompanying Lancet Neurology Reflection and Reaction. There were also trends for improvements in some secondary outcomes, including certain neuropsychiatric behaviors such as disinhibition, sleep disorders, and eating problems, said Chenoweth. Despite the significant improvement in agitation, there was no improvement in quality of life. “CADRES is an extremely important trial that might greatly affect clinical practice,” write Ballard and Aarsland. But they raise some caveats: they suggest usual care is not an adequate control because any intervention may yield non-specific effects and they suggest an education-alone intervention as better for comparison, they note the trial was brief and a longer treatment and follow-up are needed, and they lament the lack of secondary outcome benefit and absence of reduction in antipsychotic drug use, which has been found in other person-centered care interventions (see Fossey et al., 2006). On the last point, Chenoweth said, “I think one reason for that was because this was a nursing led trial and I don’t think doctors felt comfortable enough to make that decision based on what we were finding, even though they could see that their patients were definitely more settled.”
The antipsychotic drug issue may be addressed in a follow-up trial. Chenoweth is now embarking on a larger trial at 40 sites, randomized to two different treatments. “We hope to work more closely with doctors to see if they might alter drugs if it was warranted,” she said.—Tom Fagan
- Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006 Apr 1;332(7544):756-61. PubMed.
- Chenoweth L, King MT, Jeon YH, Brodaty H, Stein-Parbury J, Norman R, Haas M, Luscombe G. Caring for Aged Dementia Care Resident Study (CADRES) of person-centred care, dementia-care mapping, and usual care in dementia: a cluster-randomised trial. Lancet Neurol. 2009 Apr;8(4):317-25. PubMed.
- Ballard C, Aarsland D. Person-centred care and care mapping in dementia. Lancet Neurol. 2009 Apr;8(4):302-3. PubMed.
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