Background Feeding problems are common in dementia, and decision-makers have limited understanding of treatment options. Objectives To test whether a decision aid improves quality of decision-making about feeding options in advanced dementia. Design Cluster randomized controlled trial. Setting 24 nursing homes in North Carolina Participants Residents with advanced dementia and feeding problems and their surrogates. Intervention Intervention surrogates received an audio or print decision aid on feeding options in advanced dementia. Controls received usual care. Measurements Primary outcome was the Decisional Conflict Scale (range 1–5) measured at 3 months; other main outcomes were surrogate knowledge, frequency of communication with providers, and feeding treatment use. Results 256 residents and surrogate decision-makers were recruited. Residents’ average age was 85; 67% were Caucasian and 79% were women. Surrogates’ average age was 59; 67% were Caucasian, and 70% were residents’ children. The intervention improved knowledge scores (16.8 vs 15.1, p<0.001). After 3 months, intervention surrogates had lower Decisional Conflict Scale scores than controls (1.65 vs. 1.90, p<0.001) and more often discussed feeding options with a health care provider (46% vs. 33%, p=0.04). Residents in the intervention group were more likely to receive a dysphagia diet (89% vs.76%, p=0.04), and showed a trend toward increased staff eating assistance (20% vs.10%, p=0.08). Tube feeding was rare in both groups even after 9 months (1 intervention vs. 3 control, p=0.34). Limitations Cluster randomization was necessary to avoid contamination, but limits blinding and may introduce bias by site effect. Conclusion A decision aid about feeding options in advanced dementia reduced decisional conflict for surrogates and increased their knowledge and communication about feeding options with providers.

Context The Palliative Care Research Cooperative group (PCRC) is the first clinical trials cooperative for palliative care in the United States. Objectives To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. Methods The parent study was a multi-site randomized controlled trial enrolling adults with life expectancy anticipated to be 1–6 months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semi-structured interviews with 18 site Principal Investigators (PI) and Clinical Research Coordinators (CRC), and reviewed recruitment rates. Interviews covered 3 topics – 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. Results All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of n=381 patients. Site enrollment ranged from 1–109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients’ needs, support from clinical champions, and the additional resources of a trials cooperative group. Conclusion The recruitment experience from the multi-site PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field.

Objective In advanced dementia, feeding problems are nearly universal, and families face difficult decisions about feeding options. Initial interviews for a randomized trial were used to describe surrogates’ perceptions feeding options, and to determine if a decision aid on feeding options in advanced dementia would improve knowledge, reduce expectation of benefit from tube feeding, and reduce conflict over treatment choices for persons with advanced dementia. Design Semi-structured interview with pre-post study design for surrogates in the intervention group. Setting Twenty-four skilled nursing facilities across North Carolina participating in a cluster randomized trial. Participants Two hundred fifty-five surrogate decision-makers for nursing home residents with advanced dementia and feeding problems, in control (n=129) and intervention (n=126) groups. Intervention For intervention surrogates only, an audiovisual-print decision aid provided information on dementia, feeding problems in dementia, advantages and disadvantages of feeding tubes or assisted oral feeding options and the role of surrogates in making these decisions. Measurements The interview included open-ended items asking surrogates to report advantages and disadvantages of tube feeding and assisted oral feeding. Knowledge of feeding options was measured with 19 true-false items, and items measuring expectation of benefit from tube feeding. Surrogates reported which of these two feeding options they preferred for the person with dementia, and how confident they were in this choice; their level of conflict about the choice was measured using the Decisional Conflict Scale. Results Prior to the decision aid, surrogates described advantages and disadvantages of assisted oral feeding and tube feeding in practical, ethical and medical terms. After review of the decision aid, intervention surrogates had improved knowledge scores (15.5 vs. 16.8; p<0.001), decreased expectation of benefits from tube feeding (2.73 vs. 2.32; p = 0.001) and reduced decisional conflict (2.24 vs. 1.91, p<0.001). Surrogates preferred assisted oral feeding initially, and reported more certainty about this choice after the decision aid. Conclusion A structured decision aid can be used to improve decision-making about feeding options in dementia care.

Most families chose comfort as the primary GOC. Further research is needed to translate this preference into comfort-focused treatment plans for late-stage dementia. Clinicaltrials.gov : NCT01565642 (3/26/12).

Context. Investigators need novel methods for timely identification of patients with serious illness to test or implement new palliative care models. Objectives. The study’s aim was to develop an electronic health record (EHR) phenotype to identify patients with late-stage dementia for a clinical trial of palliative care consultation. Methods. We developed a computerized method to identify patients with dementia on hospital admission. Within a data warehouse derived from the hospital’s EHR, we used search terms of age, admission date, and ICD-9 and ICD-10 diagnosis codes to create an EHR dementia phenotype, followed by brief medical record review to confirm late-stage dementia. We calculated positive predictive value, false discovery rate, and false negative rate of this novel screening method. Results. The EHR phenotype screening method had a positive predictive value of 76.3% for dementia patients and 24.5% for late-stage dementia patients; a false discovery rate of 23.7% for dementia patients and 75.5% for late-stage dementia patients compared to physician assessment. The sensitivity of this screening method was 59.7% to identify hospitalized patients with dementia. Daily screening—including confirmatory chart reviews—averaged 20 minutes and was more feasible, efficient, and more complete than manual screening. Conclusion. A novel method using an EHR phenotype plus brief medical record review is effective to identify hospitalized patients with late-stage dementia. In health care systems with similar clinical data warehouses, this method may be applied to serious illness populations to improve enrollment in clinical trials of palliative care or to facilitate access to palliative care services.