Research in Gerontological Nursing

Featured Pilot Study 

Pilot Study of a Nonpharmacological Intervention for Delirium Superimposed on Dementia

Ann M. Kolanowski, PhD, RN, FAAN; Donna M. Fick, PhD, GCNS-BC, FGSA, FAAN; Linda Clare, PhD, MA, MSc, C.Psychol, AFBPsS; Melinda Steis, PhD, RN; Malaz Boustani, MD, MPH; Mark Litaker, PhD

Abstract

Delirium is a common neuropsychiatric syndrome that occurs most frequently in older adults with dementia and is referred to as delirium superimposed on dementia (DSD). Our aim in this pilot project was to demonstrate that implementation of cognitively stimulating activities is clinically feasible and has potential to reduce delirium severity and duration and functional loss in post-acute care settings. We randomized newly admitted participants with DSD to treatment (n = 11) and control (n = 5) conditions and conducted daily blinded assessments of delirium, delirium severity, and functional status for up to 30 days. The control group had a significantly greater decrease in physical function and mental status over time compared with the intervention group. Delirium, severity of delirium, and attention approached significance, and improvement over time favored the intervention group. Although not statistically significant, a difference in mean (7.0 versus 3.27) and median (7.0 versus 3.0) days with delirium was found, with the control group having more days of delirium.

Abstract

Delirium is a common neuropsychiatric syndrome that occurs most frequently in older adults with dementia and is referred to as delirium superimposed on dementia (DSD). Our aim in this pilot project was to demonstrate that implementation of cognitively stimulating activities is clinically feasible and has potential to reduce delirium severity and duration and functional loss in post-acute care settings. We randomized newly admitted participants with DSD to treatment (n = 11) and control (n = 5) conditions and conducted daily blinded assessments of delirium, delirium severity, and functional status for up to 30 days. The control group had a significantly greater decrease in physical function and mental status over time compared with the intervention group. Delirium, severity of delirium, and attention approached significance, and improvement over time favored the intervention group. Although not statistically significant, a difference in mean (7.0 versus 3.27) and median (7.0 versus 3.0) days with delirium was found, with the control group having more days of delirium.

Delirium is a common, although frequently unrecognized and untreated, neuropsychiatric syndrome in older adults that is characterized by a sudden decline in attention and cognition (American Psychiatric Association, 2000). Delirium occurs most frequently in older adults with dementia during acute medical conditions (Inouye, 2006) and is referred to as delirium superimposed on dementia (DSD) (Fick, Agostini, & Inouye, 2002). Because hospital length of stay is now considerably shorter than in the past, studies indicate that between 16% and 23% of older adults are being discharged with full delirium (Kiely et al., 2003). This trend shifts the care and cost of care for these individuals to post-acute care facilities. Two thirds of older adults admitted to post-acute care have delirium symptoms on admission (Marcantonio et al., 2003). Older adults who are admitted to post-acute care with delirium experience more complications, rehospitalizations, and death compared with those without delirium (Marcantonio et al., 2005).

DSD is difficult to prevent in individuals who already have reduced cognitive reserve (Marcantonio, Flacker, Wright, & Resnick, 2001). Resolution becomes vitally important because when delirium resolves slowly, or never at all, less than 50% of pre-illness functioning is realized (Kiely et al., 2006). These individuals are at high risk for poor quality of life. The loss of cognitive and physical function makes it difficult for them to return home to previously enjoyed and beneficial activities, and often presents too great a burden for their families to manage without substantial assistance. Interventions that slow the accelerated downward spiral accompanying DSD have the potential to make a major public health impact by preserving function, preventing premature institutionalization, and reducing the $152 billion national burden attributed to delirium (Leslie, Marcantonio, Zhang, Leo-Summers, & Inouye, 2008; McCusker, Cole, Dendukuri, Belzile, & Primeau, 2001; Pompei et al., 1994).

Interventions that treat DSD are not well developed because we are just beginning to understand the mechanisms involved in its etiology. Clinical practice is variable and includes interventions that target factors associated with delirium, but no strong empirical basis exists for prescribing the interventions (Carnes et al., 2003). Benzodiazepines and antipsychotic agents are also used in treatment, but their efficacy has not been established (Campbell et al., 2009). Some data indicate these drugs may actually precipitate delirium and contribute to further long-term cognitive impairment (Ellul et al., 2007; McShane et al., 1997).

We have developed a theory-based intervention for DSD that is derived from the literature on cognitive reserve and based on our prior interdisciplinary work on delirium, recreational activities, and cognitive stimulation in people with dementia (Kolanowski, Fick, Clare, Therrien, & Gill, 2010). Several lines of converging evidence indicate that delirium and dementia share many clinical, metabolic, and cellular manifestations that indicate reduced cognitive reserve (Inouye & Ferrucci, 2006; Murray et al., 1993). Some have even suggested that delirium and dementia are part of the same disorder (Inouye, 2006; Murray et al., 1993 ). It is plausible that interventions that improve cognitive reserve in one condition may also be effective in the other.

Cognitive stimulation is a nonregimented form of cognitive intervention that promotes cognitive processing aimed at general enhancement of mental functioning (Clare & Woods, 2004). Growing evidence indicates that cognitively stimulating activities improve cognitive functioning in healthy older individuals and those in mild to moderate stages of dementia by inducing neuroplastic events that support cognitive reserve (Ball et al., 2002; Boron, Willis, & Schaie, 2007; Spector et al., 2003; Willis et al., 2006). Our broad objective in this pilot project is to demonstrate that implementation of these cognitively stimulating activities is clinically feasible and has potential for reducing delirium severity and duration, as well as functional loss in post-acute care (rehabilitation) settings. The following aims guided the pilot study:

  • Aim 1: To determine the clinical feasibility of implementing our intervention, cognitively stimulating activities, in post-acute care as evidenced by (a) our ability to recruit, treat, and follow for 30 days a sample of community-dwelling older adults with mild- to moderate-stage dementia who have at least two features of delirium when admitted to post-acute care; and (b) staff-, family-, and participant-reported satisfaction with the intervention.
  • Aim 2: To determine the potential for using cognitively stimulating activities in the treatment of DSD.

Method

We received approval for the protocol from our University Institutional Review Board. This pilot study involved participants being recruited and enrolled at the time of admission to a nonprofit, 240-bed post-acute care/rehabilitation center located in central Pennsylvania. Written consent for participation was obtained from each participant’s legally authorized representative. Assent was obtained daily from each participant for assessments and implementation of the intervention.

Sample

To establish eligibility, an advanced practice nurse screened potential participants using a medical chart review and participant and family interview involving several instruments with known reliability. Inclusion criteria were: age 65 and older, English speaking, community dwelling, diagnosis of mild- to moderate-stage dementia verified by chart review and a score of 0.5 to 2.0 on the Clinical Dementia Rating scale (CDR; Hughes, Berg, Danziger, Coben, & Martin, 1982), and presence of delirium as verified by a positive finding (two or more features) on the Confusion Assessment Method (CAM; Inouye et al., 1990). Exclusion criteria were: any neurological or neurosurgical disease associated with cognitive impairment other than dementia, nonverbal, severe hearing or vision impairment, or no family or caregiver to interview.

Sixteen participants met enrollment criteria and were randomly assigned to one of two conditions: cognitive stimulation (intervention; n = 11) or usual care (control; n = 5). Random assignment was unrestricted, resulting in an unbalanced number of participants in each group and was concealed until after screening and enrollment. During the intervention phase, 1 participant in the control group and 2 in the intervention group died. In addition, 1 participant from the intervention group was discharged to home. Table 1 lists the demographic characteristics of the sample by group assignment.

Demographic Characteristics of the Sample by Group Assignment

Table 1: Demographic Characteristics of the Sample by Group Assignment

Intervention

Participants in the intervention group received nursing care that was routinely delivered for their medical-surgical condition including participation in their prescribed rehabilitation therapies. In addition, this group received cognitive stimulation delivered using simple recreational activities that were increasingly challenging, mentally stimulating, and tailored to each person’s interests and functional ability. Activities were selected by the first (A.M.K.) and third (L.C.) authors from a base of activities used in their programs of research on the behavioral symptoms of dementia (Kolanowski, Litaker, & Buettner, 2005) and cognitive rehabilitation (Clare, 2008). Examples include many common and readily available cognitive games and activities such as Name That Tune, picture puzzles, and Wheel of Fortune®. The activities were prescribed by the first (A.M.K.) and second (D.M.F.) authors on the basis of an assessment of the participant’s physical and cognitive abilities as determined by scores on the Mini-Mental State Examination (MMSE; Folstein, Folstein, & McHugh, 1975), Barthel Index (BI; Mahoney & Barthel, 1965), and an investigator-developed interest survey. The recreational activities target cognitive domains affected by delirium: attention, orientation, memory, abstract thinking, and executive functioning. Activities that stimulate processing in these domains include sound identification (e.g., birds, lawnmower; attention domain), game of “Where am I?” (orientation domain), “memory tray” with three to seven items (memory domain), explaining similarities between items (e.g., hamburger and pizza; abstract thinking domain), and calculating change after a “purchase” (executive functioning domain). As the participant achieves success with activities, the level of difficulty is increased to encourage cognitive processing.

Procedure

Participants received up to 30 minutes (mean = 26.1 minutes, SD = 8) of their respective cognitively stimulating recreational activities once per day between 1:00 p.m. and 5:00 p.m. for up to 30 consecutive days, beginning within 24 hours of admission to post-acute care. Greater detail on the intervention protocol is available in the literature (Kolanowski, Buettner, Fick, Fitzsimmons, & Cornacchione, 2008). Trained research assistants (RAs), who were undergraduate students and retired homemakers, implemented the intervention.

Currently, no standard of care exists for DSD (Siddiqi, Holt, Britton, & Holmes, 2007). Participants in the usual care group received nursing care that is routinely delivered for their medical-surgical condition including participation in their prescribed rehabilitation therapies.

Daily assessments of delirium, delirium severity, attention (the primary neuropsychological deficit in delirium), and physical function were taken between 8:00 a.m. and 11:00 a.m. by blinded RAs trained in the use of the instruments that measured the primary outcomes. To prevent treatment contamination and to maintain blinding, there was no overlap between intervention RAs and those conducting the daily assessments. At the completion of the intervention period, satisfaction surveys were completed by intervention participants, their responsible parties, and the staff who cared for them.

Measures

Delirium was measured by a structured interview consisting of the CAM, observation, and the MMSE. Delirium duration was measured daily and calculated as total number of days with two or more features of delirium on the CAM. The CAM is a standardized diagnostic algorithm, allowing people without formal psychiatric training to quickly and accurately identify delirium. CAM criteria have been validated against geriatric psychiatrists’ ratings and include (a) acute and fluctuating course, (b) inattention, and (c) either disorganized thinking or altered level of consciousness. The CAM has been validated in individuals with dementia and has a sensitivity ranging from 94% to 100%, a specificity ranging from 90% to 95%, and inter-rater reliability (kappa) of 0.81 to 1.0 (Inouye, 1990). The MMSE is a 30-item cognitive screen with test-retest reliability of 0.89 and interrater reliability of 0.83 (Folstein et al., 1975).

Delirium severity was measured daily using the Delirium Rating Scale (DRS) (Trzepacz, Baker, & Greenhouse, 1988), a 16-item clinician-rated scale validated in both delirium and dementia groups. It has good sensitivity and specificity and high interrater reliability (intraclass correlation coefficient [ICC] = 0.97). Scores range from 0 to 39; higher scores indicate greater severity.

Attention was measured using the forward digit span, a subtest of the Wechsler Adult Intelligence Scale (WAIS)-revised (Wechsler, 1981). Participants are given increasingly longer sequences of digits to repeat and receive a point for each correct sequence. The assessment ends when the participant misses two sequences in a row. The maximum possible score is 16. Higher scores indicate better attention and working memory. Median reliabilities reach 0.97 for forward digit span (Palmer & Meldon, 2003).

Physical function was measured daily using the BI (Mahoney & Barthel, 1965), a commonly used ordinal scale for assessing activities of daily living in patients receiving inpatient rehabilitation. The BI has 10 items (7 for self-care, 3 for mobility) that are scored in steps of 5 points, with a total score range from 0 (totally dependent) to 100 (fully independent). The instrument is a reliable indicator of functional ability in older adults when administered by face-to-face interview (ICC = 0.89) and on testing by different observers (ICC = 0.95 to 0.97) (Sainsbury, Seebass, Bansal, & Young, 2005; Shah, Vanclay, & Cooper, 1989).

For the intervention group only, the participant’s ability to tolerate (time on task) and respond (level of participation) to cognitive stimulation was assessed by the RA during each intervention session. A stopwatch was used to time the minutes and seconds the participant engaged in activities (time on task: 0 to 30 minutes). Level of participation was captured using a scale developed by Kovach and Magliocco (1998) for measuring extent of participation in recreational activities. Scores range from 1 to 4 with descriptors for each numerical rating (dozing, null, passive, active); higher scores indicate greater participation. In earlier work, we achieved interrater reliabilities (ICC) of 0.99 for time on task and 0.83 for level of participation (Kolanowski et al., 2005).

For preliminary analyses, we used intention to treat. The primary analysis used a mixed-model analysis of variance accounting for multiple observations per participant and included time and group by time as fixed effects. Results are reported for each aim.

Results

Aim 1: Clinical Feasibility

A number of indicators showed that the intervention is feasible to implement in the post-acute care setting. First, we were able to enact enrollment at admission, a transition point that can be stressful to both patients and family. We approached and screened 68 people with dementia on admission. Forty percent met enrollment criteria, and 65% of those gave consent. Primary reasons for exclusion were not previously hospitalized and age younger than 65. The primary reason for refusal to consent was stress of transfer.

Second, engagement data indicate we were able to deliver the treatment. Participants in the intervention group actively participated in the activities we prescribed. The mean time on task per session was 26.1 minutes (SD = 8 minutes) and level of participation was 3.8 (SD = 0.60), indicating active participation. We were also able to sustain the intervention over time: The mean number of intervention days was 22 (SD = 10.53).

Third, satisfaction data showed that 7 of the 8 intervention participants we were able to survey enjoyed the activities; 3 believed the activities aided their recovery, 3 did not know, and 2 indicated the activities did not aid recovery. Four of 7 family members believed the activities benefited the participant, and 3 did not know; 5 of 7 said it improved their family member’s mental status. All staff surveyed (n = 9) believed the activities fit with the schedule of the nursing home; 4 thought the activities improved participants’ mental status, 3 were not sure, and 1 said they did not. All staff were satisfied with implementation and would recommend it to other facilities.

Aim 2: Potential for Use in Treatment of DSD

Table 2 lists the means for the major outcomes by condition and the p values for the group, time, and group-by-time interaction. None of the analyses by group was statistically significant; however, the group-by-time interaction indicates the control group had a significantly greater decrease in physical function (BI) and mental status (MMSE) over time compared with the intervention group. Delirium (CAM), severity of delirium (DRS), and attention (digit span) all approached significance, and improvement over time favored the intervention group. Although not statistically significant (p = 0.1113), a difference in mean (7.0 versus 3.27) and median (7.0 versus 3.0) days with delirium was found, with the control group having more days of delirium.

Group Outcomes by Condition

Table 2: Group Outcomes by Condition

Limitations and Recommendations

We report the results of a small pilot project that aimed to demonstrate the feasibility and promise of implementing cognitively stimulating activities for reducing delirium severity and duration and functional loss in post-acute care settings. Several limitations of our work should be acknowledged. The sample is small, making it difficult to demonstrate obvious trends or statistical significance. Only one site was used for data collection, and our sample lacked racial and ethnic diversity. We did not look at the cost of the intervention—an important consideration in support of feasibility. These limitations will be addressed in a larger study.

Despite these limitations, we had several important findings. On the basis of enrollment, participant response to treatment, and the satisfaction surveys, we learned that our intervention (cognitive stimulation) is feasible to implement in a post-acute care population and holds promise for resolving DSD. We were able to actively engage participants with DSD in the activities according to protocol and for up to 30 days. There did not appear to be any systematic preference for one kind of activity over others. The satisfaction data indicated that staff, family, and participants varied in their consensus of what were positive aspects of the intervention. All staff believed the activities fit well into their daily routine—an important issue for translation into practice. Most family members thought the activities improved the participant’s mental status, and most participants reported they enjoyed the activities.

From a methodological perspective, assessment RAs reported that they remained naïve to treatment assignment using our time schedule for assessments and intervention; we found no instances of treatment contamination within the site. We did not encounter problems using our instruments in this population (i.e., ceiling or floor effects) and obtained variability in scores across days and participants. RAs were able to follow the intervention protocol with fidelity.

We have several suggestions for improving the design of this study. In planning for a larger clinical trial, we will add measures of abstract thinking and executive functioning to more fully measure functioning in these cognitive domains. Our inclusion criteria were sensitive enough to capture the population of interest, but we will control for terminal delirium by excluding individuals with a life expectancy of 6 months or less. We will also estimate cost of the intervention.

The findings suggest that control participants experienced greater decline over time in mental status and physical function compared with intervention participants: There was a trend for intervention participants to have fewer days with delirium, less severity of delirium, and greater gains in attention compared with control participants. We are encouraged by our preliminary data and feel they support conducting a well-powered trial of intervention efficacy.

Conclusion

Delirium is a common, deadly, persistent, and costly problem in people with dementia. There is a compelling need to develop nonpharmacological interventions that resolve DSD in a population that is vulnerable to the effects of current pharmacological treatments. Efficacious treatments for DSD have the potential to reduce poor health outcomes that are major sources of spiraling health care costs. The societal implications of helping older adults with dementia regain adequate function after hospitalization so they may return to their homes are enormous in terms of aging in place, quality of life, costs, and caregiver burden.

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Demographic Characteristics of the Sample by Group Assignment

Characteristic Intervention Group (n= 11) Control Group (n= 5)
Mean (SD) age in years 88.4 (4.9) 82.4 (2.9)
Gender (% women) 54.5 62.5
Race (% Caucasian) 100 100
Years of education (% 12 or more years) 54.5 80
Mean (SD) CDR scorea 1.1 (0.4) 1.1 (0.2)

Group Outcomes by Condition

Mean (SD) pValues
Variable Intervention Group Control Group Group Time Group by Time
BI 47.74 (21.43) 43.41 (12.89) 0.9656 <0.0001 0.001
CAM 0.19 (0.47) 0.36 (0.52) 0.8482 0.018 0.1128
DRS 6.71 (9.02) 8.51 (9.57) 0.6599 0.5802 0.0842
MMSE 16.84 (9.61) 16.25 (10.37) 0.5233 0.2495 0.0298
Digit span 5.29 (1.55) 5.18 (1.70) 0.8703 0.1594 0.113
Authors

Dr. Kolanowski is Elouise Ross Eberly Professor of Nursing, and Dr. Fick is Associate Professor of Nursing, School of Nursing, Pennsylvania State University, University Park, Pennsylvania; Dr. Clare is Professor of School Psychology, School of Psychology, Bangor University, Gwyneed, United Kingdom; Dr. Steis is National Research Service Award Postdoctoral Research Fellow, School of Nursing, NewCourtland Center for Transitions and Health, University of Pennsylvania, Philadelphia, Pennsylvania; Dr. Boustani is Associate Professor of Medicine, Indiana University Center for Aging Research, Indianapolis, Indiana; and Dr. Litaker is Associate Professor, Department of Diagnostic Sciences, School of Dentistry, University of Alabama at Birmingham, Birmingham, Alabama.

The authors disclose that they have no significant financial interests in any product or class of products discussed directly or indirectly in this activity. This study was supported by a grant from the Social Science Research Institute, Pennsylvania State University, awarded to Dr. Kolanowski and Dr. Fick.

Address correspondence to Ann M. Kolanowski, PhD, RN, FAAN, Elouise Ross Eberly Professor of Nursing, School of Nursing, Pennsylvania State University, 106 Health and Human Development East, University Park, PA 16802; e-mail: amk20@psu.edu.

Received: November 13, 2009
Accepted: May 6, 2010
Posted Online: October 29, 2010

10.3928/19404921-20101001-98

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