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The Journals of Gerontology Series A: Biological Sciences and Medical Sciences 60:798-803 (2005)
© 2005 The Gerontological Society of America

Geriatric Evaluation and Management Units in the Care of the Frail Elderly Cancer Patient

Arati V. Rao1,, Frank Hsieh2, John R. Feussner3 and Harvey Jay Cohen1

1 Geriatric Research, Education and Clinical Center (GRECC) Veterans Administration Medical Center, and Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, North Carolina.
2 Cooperative Studies Program Coordinating Center, Veterans Administration Medical Center, Palo Alto, California.
3 Department of Internal Medicine, Medical University of South Carolina, Charleston.

Address correspondence to Arati Rao, MD, Box 3003, Duke University Medical Center, Durham, NC 27710. E-mail: rao00012{at}mc.duke.edu


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 References
 
Background. Geriatric assessment has been suggested as a possibly useful approach in dealing with frail elderly cancer patients.

Methods. This was a secondary subset analysis from a randomized 2 x 2 factorial trial in 11 Department of Veterans Affairs medical centers. Hospitalized, frail patients at least 65 years old, after stabilization of their acute illness, were randomized to receive care in a geriatric inpatient unit, a geriatric outpatient clinic, both, or neither. The interventions involved core teams that provided geriatric assessment and patient management. We identified 99 patients with a diagnosis of cancer by The International Classification of Diseases, 9th Revision (ICD-9) codes, excluding all nonmelanoma skin cancers. Outcomes collected at discharge, 6 months, and 1 year after randomization were survival, changes in health-related quality of life (using the Medical Outcomes Study 36-Item Short-Form general health survey [SF-36]), activities of daily living, physical performance, health service utilization, and costs.

Results. There was no effect on mortality (1-year survival 59.6%). The changes in the SF-36 scores from randomization for emotional limitation, mental health and bodily pain (also sustained at 1 year) on the SF-36 were better for geriatric inpatient care cancer patients at discharge. There was no difference in SF-36 scores between geriatric outpatient and usual outpatient care. Days of hospitalization and overall costs were equivalent for the interventions and usual care over the 1-year study.

Conclusions. This study suggests that inpatient geriatric assessment and management may be an effective approach to the management of pain and psychological status in the elderly cancer inpatient at no greater length of hospitalization or extra cost than usual care.

THE fastest growing segment of the population is composed of people who are 65 years of age or older. By 2030, this group will comprise 20% of the U.S. population. It is estimated that 60% of all cancers occur in people over age 65. Such older cancer patients typically have multiple medical problems, take several medications simultaneously, and have an elderly caretaker, all of which provide significant challenges in their management (1). To facilitate management of such patients, comprehensive geriatric assessment (the main domains of which include functional status, gait balance and risk for falls, cognitive status, affective status, nutritional status, pain, and social function) has been used (2). Bernabei and colleagues (3) have recently proposed that using comprehensive geriatric assessment might allow better management and more efficient care of elderly patients with cancer.

Geriatric evaluation and management inpatient units and outpatient clinics use the above principle and have been shown to improve diagnostic accuracy, functional status, cognition, and placement of the elderly patient. These have been evaluated as a treatment approach in multisite trials with varying results (4–6). However, there are no studies directly assessing the impact of such programs on the care of the elderly cancer patient. A recently reported randomized controlled trial of inpatient and outpatient geriatric evaluation and management demonstrated positive effects on bodily pain, mental health, and functional status parameters of the Medical Outcomes Study 36-Item Short-Form general health survey (SF-36) in frail elderly patients (7). On the basis of these results, we hypothesized that the frail elderly cancer patient subset in particular, in this trial might have better quality-of-life outcomes if cared for in a geriatric inpatient unit.


   METHODS
Top
 Abstract
 Methods
Results
 Discussion
 References
 
The parent trial for this study was the Veterans Administration (VA) Cooperative trial entitled "A Controlled Trial of Inpatient and Outpatient Geriatric Evaluation and Management." The results have recently been published including the details of the study (7). Our study involves a secondary data analysis of the 99 cancer patients identified within this trial.

Briefly, sites (n = 11) were identified from programs at VA medical centers with established inpatient and outpatient geriatric units. A trained research assistant at each site identified potentially eligible patients: age ≥65 years, hospitalized on a medical or surgical ward, and expected length of stay ≥2 days, and frail. Frailty was defined as having at least two of the following: dependence in at least one basic activity of daily living (ADL), stroke within 3 months, previous falls, difficulty ambulating, malnutrition, dementia, depression, unplanned admission in the last 3 months, prolonged bed rest, or incontinence. Excluded were patients who were: admitted from a nursing home, previously hospitalized in the geriatric inpatient unit, already followed by the geriatric outpatient clinic, currently enrolled in another clinical trial, severely or terminally ill, severely demented, non-English speaking, lacking access to a telephone for follow-up, and unwilling or unable to return for follow-up clinic visits. Our eligibility criteria were designed to select patients most likely to benefit from a program of geriatric evaluation and management from previous VA published "targeting criteria" and the recommendations of a panel of experts (8–10). A Charlson comorbidity index was calculated on all patients (11).

Patients were considered for enrollment when the geriatric team judged that they were stable from their acute illness. In the 2 x 2 factorial study, subjects were randomized to be transferred to a geriatric evaluation and management unit or continue to receive usual inpatient care and, at point of discharge, to be discharged to either a geriatric outpatient clinic or usual outpatient care. Stratified randomization occurred within site and level of functional status. Outpatient status (i.e., geriatric or usual care) was revealed to the site within 24 hours prior to discharge. Patients were enrolled between August 31, 1995, and January 31, 1999. All patients enrolled gave written informed consent. For the purpose of our analysis, patients with a diagnosis of cancer were identified using The International Classification of Diseases, 9th Revision (ICD-9) codes. Patients with nonmelanoma skin cancers were not included in the cancer group.

The interventions involved core teams that provided geriatric assessment and patient management according to VA standards and published guidelines (12). Teams included a geriatric medicine attending physician, fellow, or intern; a nurse practitioner; and a social worker. A clinical pharmacologist, dietician, physical or occupational therapist, and supervised trainees from optometry, dentistry, and audiology were variably involved in an extended team. The intervention involved obtaining a complete medical history and physical examination (within 3 days for geriatric inpatients); screening for geriatric syndromes; developing a problem list; assessing functional status, cognition, and nutritional status; evaluating caregiver capability; assessing social situation; delivering preventive services; developing a care plan; and (on inpatient service) to meet at least twice weekly to discuss plans. The core geriatric team provided similar care adapted to the outpatient setting (7). With regard to the cancer patients, we thought that timely and prompt management with opioids by a geriatrician and a clinical pharmacologist would positively affect cancer pain. Also, early intervention by the team could be beneficial in the management of other symptoms such as depression and anxiety in elderly cancer patients. Usual care inpatients received all available hospital services except those from the geriatric inpatient core team. Usual care outpatients were provided at least one follow-up in an appropriate clinic. Follow-up data were obtained immediately after discharge and at 6 and 12 months post-randomization.

The primary outcomes were survival and health-related quality of life (HRQOL), measured by the SF-36 (13). Scores on the SF-36 were adjusted so that, for each item, higher scores indicated better functioning. Changes in SF-36 scores that differ between groups by 2 or more points on a scale of 0–100 have been shown to be clinically or socially meaningful (14). Secondary outcomes were functional status measured by basic (15) and instrumental ADLs (16) and by physical performance which was measured by the Physical Performance Test (PPT) (17). The scale for basic ADLs included bathing, dressing, toileting, transferring, feeding, and continence, with a score of 1 for independent functioning on each and a maximal score of 6. The scale for instrumental ADL included meal preparation, housecleaning, medication management, financial management, driving or arranging transportation, telephone use, and shopping with a score of 1 for independent functioning on each and a maximal score of 9. The PPT has been tested to be a valid and reliable instrument in assessing functional status and physical performance in the elderly (17,18). The PPT was scored on a scale of 1 to 4, with a maximal score of 28 and higher scores reflecting better performance. Health services use and costs were other secondary outcomes that were measured by information collected from the decentralized hospital computer program at each site, centralized VA databases, and Medicare databases (19).

All data during hospitalization were collected on predesignated data forms that were filled out by patients (SF-36) or a research assistant. All follow-up data, except for PPT results, were gathered via a telephone call to the patient by a centralized research assistant, blinded to the patient's study group status, who recorded all answers to the survey questions. All forms were directly faxed to the Palo Alto coordinating center, and the Datafax program (Clinical DataFax Systems, Hamilton, Ontario) was used to enter and manage data.

The primary data analysis strategy for this report involved assessing the effect of geriatric inpatient and outpatient care on the 99 cancer patients. Log rank statistics and Cox regression were used for survival analysis. A two-tailed t test was used to test the change from baseline of SF-36 summary scores, basic ADL scores, and instrumental ADL scores at discharge, 6-month, and 12-month follow-up. The same test was also applied to the PPT scores and to the total number of hospital admissions. The analysis of SF-36 with eight variables, ADL with three variables (physical, instrumental, and PPT), and cost data were planned independently. The conventional significance level is.05 for each unrelated comparison, hence we used a significance level of p ≤.01 for all multiple comparisons to approximate the overall level for both SF-36 and ADL variables. Also, the SF-36 data may not be normally distributed but were not skewed enough to justify a normal transformation. The resulting p values from both parametric (i.e., t test) and nonparametric methods are very close.

For total cost data and total days in the hospital, a transformation log (x + 1) was performed on the data before t test comparisons. The health services and cost data did not involve multiple comparisons, hence significance was assumed for comparisons with p ≤.05. All p values reported in this study are two-sided. Two multivariate analyses were performed in this study: analysis of variance (ANOVA) for health-related variables with adjustment to baseline, and Cox regression model for survival endpoint with treatment groups as the only predictors. We used SAS statistical packages PROC GLM and PROC PHGLM to carry out the analyses. These were simple analyses, and no variable selection was needed.


   RESULTS
Top
 Abstract
 Methods
 Results
Discussion
 References
 
In our study, 99 patients with a diagnosis of cancer (excluding nonmelanoma skin cancers) were identified by ICD-9 codes. Of the cancers identified, 25 patients had prostate cancer, 16 patients had lung cancer, 11 patients had hematologic malignancies, 10 patients had ill-defined malignancies (including metastatic adenocarcinoma of unknown primary), 10 patients had colon or other gastrointestinal tumors, 6 patients had head and neck cancer, and 6 patients had bladder or renal cancer. Of note, 15 patients carried a diagnosis of secondary cancer with bony metastasis; these patients were evenly distributed among the different treatment groups. Because this was a secondary analysis, we were limited in our ability to gather details on disease status regarding stage of cancer, active treatment, length of disease, and response to therapy. We also do not have data on whether these patients were receiving curative or palliative therapy. All of these 99 cancer patients were followed successfully for 1 year or until death. Over 99% of all total potential follow-up interviews at 6 and 12 months were obtained successfully by telephone interview. Though not preplanned, the number of cancer patients in the four treatment groups is similar (Table 1). There was no difference in baseline demographics of the cancer patients among the different randomization groups.


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  		Table 1. Baseline Characteristics of 99 Cancer Patients in Four Treatment Groups.

 
There was no difference in survival for the cancer patients regardless of their treatment group (Figure 1). Moreover, there was no significant difference in survival in main effects analyses of geriatric inpatient care (geriatric inpatient and usual care outpatient plus geriatric inpatient and geriatric outpatient care vs usual inpatient and usual outpatient care plus usual inpatient and geriatric outpatient care) and geriatric outpatient care (geriatric outpatient and usual care inpatient plus geriatric outpatient and geriatric inpatient vs usual care outpatient and usual care inpatient plus usual care outpatient and geriatric inpatient) and no significant interaction effects. Main effects analysis to determine the impact of the geriatric evaluation and management unit and clinic on quality of life revealed positive effects of geriatric inpatient care seen at discharge and 6-month follow-up in SF-36 bodily pain, emotional limitation, and mental health (Table 2). The most striking effect was that on bodily pain; it was the only effect sustained at 1 year. All of these positive effects were limited to inpatient care, and there was no effect of geriatric outpatient care on any of the HRQOL parameters in the 99 cancer patients. There was no effect of either inpatient or outpatient geriatric care on the functional status of cancer patients (Table 2).



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  		Figure 1. Kaplan–Meier survival curves for interaction effects on 99 cancer patients. Number of deaths/Number of patients at risk for the four groups: Geriatric inpatient-outpatient care: 3 months 4/25, 6 months 8/25, and 12 months 9/25; geriatric inpatient care–usual outpatient care: 3 months 1/19, 6 months 2/19, and 12 months 6/19; usual inpatient care–geriatric outpatient care: 3 months 3/28, 6 months 8/28, and 12 months 13/28; usual inpatient-outpatient care: 3 months 5/27, 6 months 6/27, and 12 months 12/27. UCIP = Usual Care, Inpatient; UCOP = Usual Care, Outpatient; GEMU = Geriatric Evaluation and Management Unit; GEMC = Geriatric Evaluation and Management Clinic

 

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  		Table 2. Main Effects of Geriatric Evaluation and Management Inpatient and Outpatient Care on Health-Related Quality of Life and Functional Status of 99 Cancer Patients.

 
Cancer patients randomized to geriatric inpatient care had a somewhat longer length of stay on index hospitalization, but this was not statistically significant (31.7 days vs. 21.9 days; p =.08). There were no significant differences in number of hospitalizations during follow-up among the groups, and the geriatric inpatient cancer patients spent slightly (but not significantly) more days in the hospital (15.1 days vs 14.9 days; p =.81) over the 1 year of the study. The total numbers of days of hospitalization were 46.9 versus 36.8 (p =.27).

There was no difference in total hospital costs over the 1 year of the study for the cancer patients who received geriatric inpatient care as compared with usual inpatient care ($47,300 vs. $45,500; p =.84) (Table 3). Total geriatric outpatient costs were not significantly different from usual outpatient care costs for the cancer patients ($44,700 vs. $48,100; p =.74).


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  		Table 3. Total Cost Per Cancer Patient.

 

   DISCUSSION
Top
 Abstract
 Methods
 Results
 Discussion
References
 
The management of cancer in the elderly patient presents significant challenges, which are being recognized increasingly (20). Frail older cancer patients present with decreased physiologic reserve, comorbidities, and polypharmacy; an organized approach to assessment and management may allow them to maximize both quantity and quality of life. A good quality of life is perhaps the most important consideration for the elderly cancer patient (21–25), but how to maximize quality of life is poorly understood. Pain has a significant impact on quality of life. A high prevalence of pain has also been reported in seriously ill and nursing home patients. The Hospitalized Elderly Longitudinal Project (26) showed that one of three patients died in severe pain.

Our report, a subset analysis of 99 cancer patients from a broader randomized study, has shown a positive effect of comprehensive geriatric inpatient care on bodily pain, emotional limitation, and mental health. The effects on bodily pain are striking in magnitude and were sustained for 1 year, whereas the effect on mental health and emotional limitation were sustained for 6 months. The order of magnitude of these effects is well above that shown to have clinically and/or socially significant association (14). There is no improvement in the survival rate of cancer patients, although survival analysis may be limited by sample size.

The intervention offered by geriatric inpatient care appeared to establish a situation which led to better control of pain in these elderly cancer patients even up to a year later. A number of patients in our study had bony metastatic disease, so the effect on bodily pain would likely be important in improving quality of life. The reasons that patients had more effective pain management in the geriatric inpatient unit is not totally clear. We hypothesize that geriatric medicine attending physicians and house staff may have been more attentive to assessing pain in these patients. Older patients are at risk for undertreatment of pain because of underestimation of their sensitivity to pain, the expectation that they tolerate pain well, and misconception about their ability to benefit from the use of opioids (27). While admitted to the geriatric inpatient unit, there may have been better interdisciplinary care, more pain-team consultations, along with physical and occupational therapy. A more thorough documentation of pain severity, opioid dose, and rescue doses may have been possible with the use of a clinical pharmacist in managing pain and decreasing drug-drug interactions. There is also a high incidence of depression, which has been documented in patients with cancer (28). The positive effect on mental health may also have contributed to decreasing pain in these patients. These issues are all amenable to future study. Comprehensive geriatric assessment has been shown even in other studies to be more effective in the inpatient management of patients. The same assessment when applied to outpatient care has been shown to be less effective (7,29–31).

Thus, the results of our analysis suggest that geriatric inpatient care specifically targeted to the elderly cancer patient may provide an effective approach to symptom management and improve quality of life regardless of whether survival is affected. Geriatric evaluation and management appears to be able to preferentially impact such older cancer patients and to assist in management of pain and emotional and mental health, resulting in sustained improvement in their quality of life with no increase in costs.

Our study has limitations. The first and main one is that this was a secondary analysis of a subset of patients based on a hypothesis that comprehensive geriatric assessment would benefit the frail, elderly cancer patient. Second, we also have no information on the 99 cancer patients in terms of stage of cancer, active treatment, length of disease, and response to therapy, all factors that affect quality of life. Third, we relied on the SF-36 questionnaire to assess cancer pain. Although it has been validated in assessing different types of pain and is frequently used because of its convenience, we are unaware of its validity in assessing cancer pain, especially in elderly patients. Fourth, this study was conducted within the VA system, thus most of the patients were men. Lastly, this was a multisite study, and there may have been variations in management across the country, although the study adhered to standard VA guidelines for geriatric assessment and management.

In conclusion, this study, although not definitive as a subset analysis, suggests that comprehensive geriatric assessment using geriatric evaluation and management inpatient units impacts the quality of life of the elderly cancer patient—in particular, in the management of pain and mental and emotional health. These effects were achieved with no overall increase in hospitalization or cost of care over the year of the study. These results should be viewed as suggesting an area for future in-depth study via prospective randomized trials.


   Acknowledgments
 
This work was supported by the Department of Veterans Affairs Cooperative Studies Program. We would like to acknowledge Miss Yajie Wang, who helped with much of the statistical analysis.


   Footnotes
 
Decision Editor: John E. Morley, MB, BCh

Received January 22, 2004

Accepted January 23, 2004


   References
Top
 Abstract
 Methods
 Results
 Discussion
 References
 

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