The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study: Design, protocols, and operations.

The Neuroimaging and Sensory Testing (NIST) Study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a cross-sectional, case-control study designed to investigate whether disrupted brain connectivity and sensory processing are associated with abnormal lower urinary tract symptoms (LUTS) in patients with overactive bladder syndrome (OAB). The NIST Study tests the hypotheses that patients with urinary urgency will demonstrate: (1) abnormal functional and structural connectivity of brain regions involved in urinary sensation on magnetic resonance imaging (MRI), and (2) hypersensitivity to painful (pressure) and non-painful (auditory) sensory stimuli on quantitative sensory testing (QST), compared to controls. Male and female adults (18 years or older) who present at one of the six participating LURN clinical centers for clinical care of their LUTS, with symptoms of urinary urgency with or without urgency urinary incontinence, are eligible to participate. The NIST Study is the largest MRI and QST study of its kind, yielding a neuroimaging and sensory testing dataset unprecedented in OAB research. Advanced multi-modal techniques are used to understand brain functional and structural connectivity, including gray matter volume, and sensory function. Unlike previous MRI studies which involved invasive catheterization and repeated cycles of non-physiologic bladder filling and emptying via a catheter, we use a water ingestion protocol to mimic more physiological bladder filling through natural diuresis. Furthermore, these data will be used in concert with other phenotyping data to improve our understanding of clinically meaningful subtypes of patients with LUTS in order to improve patient care and management outcomes.

Fidelity to a behavioral intervention to improve goals of care decisions for nursing home residents with advanced dementia.

BACKGROUND/AIMS: Ensuring fidelity to a behavioral intervention implemented in nursing homes requires awareness of the unique considerations of this setting for research. The purpose of this article is to describe the goals of care cluster-randomized trial and the methods used to monitor and promote fidelity to a goals of care decision aid intervention delivered in nursing homes. METHODS: The cluster randomized trial tested whether a decision aid for goals of care in advanced dementia could improve (1) the quality of communication and decision-making, (2) the quality of palliative care, and (3) the quality of dying for nursing home residents with advanced dementia. In 11 intervention nursing homes, family decision-makers for residents with advanced dementia received a two-component intervention: viewing a video decision aid about goals of care choices and then participating in a structured decision-making discussion with the nursing home care plan team, ideally within 3 months after the decision aid was viewed. Following guidelines from the National Institutes of Health Behavior Change Consortium, fidelity was assessed in study design, in nursing home staff training for intervention implementation, and in monitoring and receipt of the intervention. We also monitored the content and timing of goals of care discussions. RESULTS: Investigators enrolled 151 family decision-maker/resident dyads in intervention sites; of those, 136 (90%) received both components of the intervention, and 92%-99% of discussions addressed each of four recommended content areas-health status, goals of care, choice of a goal, and treatment planning. A total of 94 (69%) of the discussions between family decision-makers and the nursing home care team were completed within 3 months. CONCLUSION: The methods we used for intervention fidelity allowed nursing home staff to implement a goals of care decision aid intervention for advanced dementia. Key supports for implementation included design features that aligned with nursing home practice, efficient staff training, and a structured guide for goals of care discussions between family decision-makers and staff. These approaches may be used to promote fidelity to behavioral interventions in future clinical trials.

Development and testing of a decision aid on goals of care for advanced dementia.

OBJECTIVES: Decision aids are effective to improve decision-making, yet they are rarely tested in nursing homes (NHs). Study objectives were to (1) examine the feasibility of a goals of care (GOC) decision aid for surrogate decision-makers (SDMs) of persons with dementia; and (2) to test its effect on quality of communication and decision-making. DESIGN: Pre-post intervention to test a GOC decision aid intervention for SDMs for persons with dementia in NHs. Investigators collected data from reviews of resident health records and interviews with SDMs at baseline and 3-month follow-up. SETTING: Two NHs in North Carolina. PARTICIPANTS: Eighteen residents who were over 65 years of age, had moderate to severe dementia on the global deterioration scale (5, 6, or 7), and an English-speaking surrogate decision-maker. INTERVENTION: (1) GOC decision aid video viewed by the SDM and (2) a structured care plan meeting between the SDM and interdisciplinary NH team. MEASUREMENTS: Surrogate knowledge, quality of communication with health care providers, surrogate-provider concordance on goals of care, and palliative care domains addressed in the care plan. RESULTS: Eighty-nine percent of the SDMs thought the decision aid was relevant to their needs. After viewing the video decision aid, SDMs increased the number of correct responses on knowledge-based questions (12.5 vs 14.2; P < .001). At 3 months, they reported improved quality of communication scores (6.1 vs 6.8; P = .01) and improved concordance on primary goal of care with NH team (50% vs 78%; P = .003). The number of palliative care domains addressed in the care plan increased (1.8 vs 4.3; P < .001). CONCLUSIONS: The decision-support intervention piloted in this study was feasible and relevant for surrogate decision-makers of persons with advanced dementia in NHs, and it improved quality of communication between SDM and NH providers. A larger randomized clinical trial is underway to provide further evidence of the effects of this decision aid intervention.

Provider staffing effect on a decision aid intervention.

This study examined the association between Nurse Practitioner (NP) and Physician Assistant (PA) staffing in nursing homes and the effect of a decision aid regarding feeding options in dementia on the frequency of surrogate-provider discussions and on surrogates' decisional conflict. We compared these outcomes for facilities that had no NPs/PAs, part-time-only NP/PA staffing, and full-time NP/PA staffing. The sample included 256 surrogate decision makers from 24 nursing homes. The decision aid was associated with significant increases in discussion rates in facilities with part-time or no NP/PA staffing (26% vs. 51%, p < .001, and 13% vs. 41%, p < .001, respectively) and decreases in decisional conflict scores (-0.08 vs. -0.047, p = .008, and -0.30 vs. -0.68, p = .014, respectively). Sites with full-time NP/PA staffing had high baseline rates of discussions (41%). These findings suggest that the decision aid and full-time NP/PA staffing can enhance surrogate decision making in nursing homes.

Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial.

OBJECTIVES: To test whether a decision aid improves quality of decision-making about feeding options in advanced dementia. DESIGN: Cluster randomized controlled trial. SETTING: Twenty-four 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: Two hundred fifty-six 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 < .001). After 3 months, intervention surrogates had lower Decisional Conflict Scale scores than controls (1.65 vs 1.90, P < .001) and more often discussed feeding options with a healthcare provider (46% vs 33%, P = .04). Residents in the intervention group were more likely to receive a dysphagia diet (89% vs 76%, P = .04) and showed a trend toward greater staff eating assistance (20% vs 10%, P = .08). Tube feeding was rare in both groups even after 9 months (1 intervention vs 3 control, P = .34). 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.

Oral feeding options for people with dementia: a systematic review.

UNLABELLED: To review the benefits of oral feeding options in people with dementia. DESIGN: Systematic literature search with review of potentially eligible studies by two independent investigators. SETTING: PubMed/MEDLINE, EMBASE, the Cochrane Library, CINAHL, and PsychINFO literature indices between January 1990 and October 2009. PARTICIPANTS: Clinical trials with random or nonrandom control groups were included if they reported on clinical outcomes of oral feeding interventions for people with dementia. MEASUREMENTS: Investigators abstracted data from included studies using a structured instrument. Studies were graded on quality and potential bias, and overall strength of evidence was summarized. RESULTS: Thirteen controlled trials provided data on use of supplements for people with dementia, and 12 controlled trials tested assisted feeding or other interventions. Studies provide moderate-strength evidence for high-calorie supplements, and low-strength evidence for appetite stimulants, assisted feeding, and modified foods to promote weight gain in people with dementia. The few studies measuring function or survival showed no difference. CONCLUSION: High-calorie supplements and other oral feeding options can help people with dementia with feeding problems to gain weight; they are unlikely to improve other outcomes. These treatments can be offered alone or in combination as an alternative to tube feeding.

Successful clinical trial research in nursing homes: the Improving Decision-Making Study.

BACKGROUND: One in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice. PURPOSE: Our objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population. METHODS: The study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina. RESULTS: This trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population. LIMITATIONS: Cluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses. CONCLUSIONS: Strategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care.