Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial.

BACKGROUND: The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare providers empower seniors and their caregivers in making health-related decisions. METHODS: In two phases, we will: (1) design and tailor the intervention; and (2) implement and evaluate it. We will use theory and user-centered design to tailor an intervention comprising a distance professional training program on shared decision-making and five shared decision-making tools dealing with difficult decisions often faced by seniors with dementia and their caregivers. Each tool will be designed in two versions, one for clinicians and one for patients. We will recruit 49 clinicians and 27 senior/caregiver to participate in three cycles of design-evaluation-feedback of each intervention components. Besides think-aloud and interview approaches, users will also complete questionnaires based on the Theory of Planned Behavior to identify the factors most likely to influence their adoption of shared decision-making after exposure to the intervention. We will then modify the intervention by adding/enhancing behavior-change techniques targeting these factors. We will evaluate the effectiveness of this tailored intervention before/after implementation, in a two-armed, clustered randomized trial. We will enroll a convenience sample of six primary care clinics (unit of randomization) in the province of Quebec and recruit the clinicians who practice there (mostly family physicians, nurses, and social workers). These clinics will then be randomized to immediate exposure to the intervention or delayed exposure. Overall, we will recruit 180 seniors with dementia, their caregivers, and their healthcare providers. We will evaluate the impact of the intervention on patient involvement in the decision-making process, decisional comfort, patient and caregiver personal empowerment in relation to their own healthcare, patient quality of life, caregiver burden, and decisional regret. DISCUSSION: The intervention will empower patients and their caregivers in their healthcare, by fostering their participation as partners during the decision-making process and by ensuring they make informed decisions congruent with their values and priorities. TRIAL REGISTRATION: ClinicalTrials.org, NCT02956694 . Registered on 31 October 2016.

Five shared decision-making tools in 5 months: use of rapid reviews to develop decision boxes for seniors living with dementia and their caregivers.

BACKGROUND: Decision support tools build upon comprehensive and timely syntheses of literature. Rapid reviews may allow supporting their development by omitting certain components of traditional systematic reviews. We thus aimed to describe a rapid review approach underlying the development of decision support tools, i.e., five decision boxes (DB) for shared decision-making between seniors living with dementia, their caregivers, and healthcare providers. METHOD: We included studies based on PICO questions (Participant, Intervention, Comparison, Outcome) describing each of the five specific decision. We gave priority to higher quality evidence (e.g., systematic reviews). For each DB, we first identified secondary sources of literature, namely, clinical summaries, clinical practice guidelines, and systematic reviews. After an initial extraction, we searched for primary studies in academic databases and grey literature to fill gaps in evidence. We extracted study designs, sample sizes, populations, and probabilities of benefits/harms of the health options. A single reviewer conducted the literature search and study selection. The data extracted by one reviewer was verified by a second experienced reviewer. Two reviewers assessed the quality of the evidence. We converted all probabilities into absolute risks for ease of understanding. Two to five experts validated the content of each DB. We conducted descriptive statistical analyses on the review processes and resources required. RESULTS: The approach allowed screening of a limited number of references (range: 104 to 406/review). For each review, we included 15 to 26 studies, 2 to 10 health options, 11 to 62 health outcomes and we conducted 9 to 47 quality assessments. A team of ten reviewers with varying levels of expertise was supported at specific steps by an information specialist, a biostatistician, and a graphic designer. The time required to complete a rapid review varied from 7 to 31 weeks per review (mean ± SD, 19 ± 10 weeks). Data extraction required the most time (8 ± 6.8 weeks). The average estimated cost of a rapid review was C$11,646 (SD = C$10,914). CONCLUSIONS: This approach enabled the development of clinical tools more rapidly than with a traditional systematic review. Future studies should evaluate the applicability of this approach to other teams/tools.

Attention following traumatic brain injury: Neuropsychological and driving simulator data, and association with sleep, sleepiness, and fatigue.

The objectives of this study were to compare individuals with traumatic brain injury (TBI) and healthy controls on neuropsychological tests of attention and driving simulation performance, and explore their relationships with participants' characteristics, sleep, sleepiness, and fatigue. Participants were 22 adults with moderate or severe TBI (time since injury ≥ one year) and 22 matched controls. They completed three neuropsychological tests of attention, a driving simulator task, night-time polysomnographic recordings, and subjective ratings of sleepiness and fatigue. Results showed that participants with TBI exhibited poorer performance compared to controls on measures tapping speed of information processing and sustained attention, but not on selective attention measures. On the driving simulator task, a greater variability of the vehicle lateral position was observed in the TBI group. Poorer performance on specific subsets of neuropsychological variables was associated with poorer sleep continuity in the TBI group, and with a greater increase in subjective sleepiness in both groups. No significant relationship was found between cognitive performance and fatigue. These findings add to the existing evidence that speed of information processing is still impaired several years after moderate to severe TBI. Sustained attention could also be compromised. Attention seems to be associated with sleep continuity and daytime sleepiness; this interaction needs to be explored further.

Impact of comorbid anxiety and depressive disorders on treatment response to cognitive behavior therapy for insomnia.

OBJECTIVE: To evaluate the impact of comorbid anxiety or depressive disorders on treatment response to cognitive-behavior therapy (CBT) for insomnia, behavior therapy (BT), or cognitive therapy (CT). METHOD: Participants were 188 adults (117 women; Mage = 47.4 years) with chronic insomnia, including 45 also presenting a comorbid anxiety or mild to moderate depressive disorder. They were randomized to BT (n = 63), CT (n = 65), or CBT (n = 60). Outcome measures were the proportion of treatment responders (decrease of ≥8 points on the Insomnia Severity Index; ISI) and remissions (ISI score < 8) and depression and anxiety symptoms. RESULTS: Proportion of treatment responders and remitters in the CBT condition was not significantly different between the subgroups with and without comorbidity. However, the proportion of responders was lower in the comorbidity subgroup compared to those without comorbidity in both the BT (34.4% vs. 81.6%; p = .007) and CT (23.6% vs. 57.6%; p = .02) alone conditions, although remission rates and prepost ISI change scores were not. Pre to post change scores on the depression (-10.6 vs. -3.9; p < .001) and anxiety measures (-9.2 vs. -2.5; p = .01) were significantly greater in the comorbidity subgroup relative to the subgroup without comorbidity but only for those treated with the full CBT; no difference was found for those treated with either BT or CT alone. CONCLUSIONS: The presence of a comorbid anxiety or mild to moderate depressive disorder did not reduce the efficacy of CBT for insomnia, but it did for its single BT and CT components when used alone. (PsycINFO Database Record

Cognitive impairment in individuals with insomnia: clinical significance and correlates.

STUDY OBJECTIVES: The aims of this study were to (1) investigate the nature of cognitive impairment in individuals with insomnia, (2) document their clinical significance, (3) examine their correlates, and (4) explore differences among individuals with insomnia with and without cognitive complaints. DESIGN: Participants underwent 3 consecutive nights of polysomnography. On the morning following the third night, they completed a battery of questionnaires and neuropsychological tests. PARTICIPANTS: The sample included 25 adults with primary insomnia (mean age: 44.4 ± 11.5 y, 56% women) and 16 controls (mean age: 42.8 ± 12.9 y, 50% women) matched for sex, age, and education. INTERVENTION: N/A. MEASUREMENT AND RESULTS: Participants completed neuropsychological tests covering attention, memory, working memory, and executive functions, as well as questionnaires assessing the subjective perception of performance, depression, anxiety, fatigue, sleepiness, and hyperarousal. There were significant group differences for the attention and episodic memory domains. Clinically significant deficits were more frequent in the insomnia group. Within the insomnia group, individuals with cognitive complaints exhibited significantly poorer performance on a larger number of neuropsychological variables. All impaired aspects of performance were significantly associated with either subjective or objective sleep continuity, and some were also independently related to sleep microstructure (i.e., relative power for alpha frequencies) or selected psychological variables (i.e., beliefs or arousal). CONCLUSIONS: These findings suggest clinically significant alterations in attention and episodic memory in individuals with insomnia. Objective deficits were more pronounced and involved more aspects of performance in a subgroup of individuals with cognitive complaints. These deficits appear associated with sleep continuity, and may also be related to sleep microstructure and dysfunctional beliefs.

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial.

OBJECTIVE: To examine the unique contribution of behavior therapy (BT) and cognitive therapy (CT) relative to the full cognitive behavior therapy (CBT) for persistent insomnia. METHOD: Participants were 188 adults (117 women; M age = 47.4 years, SD = 12.6) with persistent insomnia (average of 14.5 years duration). They were randomized to 8 weekly, individual sessions consisting of BT (n = 63), CT (n = 65), or CBT (n = 60). RESULTS: Full CBT was associated with greatest improvements, the improvements associated with BT were faster but not as sustained and the improvements associated with CT were slower and sustained. The proportion of treatment responders was significantly higher in the CBT (67.3%) and BT (67.4%) relative to CT (42.4%) groups at post treatment, while 6 months later CT made significant further gains (62.3%), BT had significant loss (44.4%), and CBT retained its initial response (67.6%). Remission rates followed a similar trajectory, with higher remission rates at post treatment in CBT (57.3%) relative to CT (30.8%), with BT falling in between (39.4%); CT made further gains from post treatment to follow up (30.9% to 51.6%). All 3 therapies produced improvements of daytime functioning at both post treatment and follow up, with few differential changes across groups. CONCLUSIONS: Full CBT is the treatment of choice. Both BT and CT are effective, with a more rapid effect for BT and a delayed action for CT. These different trajectories of changes provide unique insights into the process of behavior change via behavioral versus cognitive routes.

Insomnia and daytime cognitive performance: a meta-analysis.

OBJECTIVES: Individuals with insomnia consistently report difficulties pertaining to their cognitive functioning (e.g., memory, concentration). However, objective measurements of their performance on neuropsychological tests have produced inconsistent findings. This meta-analysis was conducted to provide a quantitative summary of evidence regarding the magnitude of differences between individuals with primary insomnia and normal sleepers on a broad range of neuropsychological measures. METHODS: Reference databases (PubMed, PsycInfo, Dissertation Abstracts International) were searched for studies comparing adults with primary insomnia to normal sleepers on neuropsychological measures. Dependent variables related to cognitive and psychomotor performance were extracted from each study. Variables were classified independently by two licensed neuropsychologists according to the main cognitive function being measured. Individual effect sizes (Cohen's d) were weighted by variability and combined for each cognitive function using a fixed effects model. Average effect sizes and their 95% confidence intervals were computed for each cognitive function. RESULTS: Twenty-four studies met inclusion criteria, for a total of 639 individuals with insomnia and 558 normal sleepers. Significant impairments (p<0.05) of small to moderate magnitude were found in individuals with insomnia for tasks assessing episodic memory (ES = -0.51), problem solving (ES = -0.42), manipulation in working memory (ES = -0.42), and retention in working memory (ES = -0.22). No significant group differences were observed for tasks assessing general cognitive function, perceptual and psychomotor processes, procedural learning, verbal functions, different dimensions of attention (alertness, complex reaction time, speed of information processing, selective attention, sustained attention/vigilance) and some aspects of executive functioning (verbal fluency, cognitive flexibility). CONCLUSION: Individuals with insomnia exhibit performance impairments for several cognitive functions, including working memory, episodic memory and some aspects of executive functioning. While the data suggests that these impairments are of small to moderate magnitude, further research using more ecologically valid measures and normative data are warranted to establish their clinical significance.

Relations between sleep, fatigue, and health-related quality of life in individuals with insomnia.

OBJECTIVE: This study explored the relations between sleep, fatigue, and health-related quality of life in a sample of individuals with chronic insomnia. METHODS: A total of 160 adults meeting the diagnostic criteria for chronic insomnia underwent three nights of polysomnography (PSG) and completed sleep diaries and questionnaires assessing daytime functioning including fatigue and health-related quality of life. RESULTS: A cluster analysis was conducted based on PSG-defined sleep disturbances and fatigue severity. A four-cluster solution (R(2)=0.68) was found, classifying individuals as having either (a) both severe sleep disturbance and severe fatigue (n=15); (b) severe sleep disturbance but milder fatigue (n=15); (c) milder sleep disturbance but severe fatigue (n=68); or (d) both milder sleep disturbance and milder fatigue (n=61). Health-related quality of life was lower in both clusters with severe fatigue compared to those with milder fatigue and was further decreased when severe sleep disturbances were present. Relations between several indicators of fatigue and health-related quality of life were then examined using factor analysis in order to identify different domains of impairment. A three-factor structure was selected, suggesting that daytime symptoms can be classified as relating to fatigue, physical health, or mental health. These different subtypes of daytime impairment were predicted by distinct sets of variables. CONCLUSION: More severe fatigue is not necessarily related to poorer PSG-defined sleep but appears associated with greater impairment in health-related quality of life. Fatigue and health-related quality of life appear to be distinct but interrelated constructs.

Cognitive performance and sleep quality in the elderly suffering from chronic insomnia. Relationship between objective and subjective measures.

OBJECTIVE: The objective of the present study was to evaluate the relationship between objective and subjective sleep quality and objective and subjective evaluation of cognitive performance in older adults suffering of chronic insomnia (using or not benzodiazepines, BZs) or self-reported good sleepers. METHODS: Three groups of participants 55 years and older were evaluated: 20 insomnia sufferers using BZs chronically, 20 drug-free insomnia sufferers and 20 good sleepers. Objective sleep (PSG) and subjective sleep (sleep diaries, SD) were measured. Objective measures of cognitive performance (attention/concentration, verbal/visual memory, executive function and psychomotor speed) and subjective perception of daily performance were evaluated. RESULTS: Correlational analysis revealed that objective and subjective measures of daytime performance are differentially related to sleep quality for the three groups. An objective good night of sleep is associated with better cognitive performance in good sleepers and drug-free individuals. On the other hand, the impression of having slept well is related to better cognitive performance in good sleepers and chronic insomnia sufferers using BZs. CONCLUSION: Daytime performance and sleep quality are related, but differently so for a good sleeper, an insomnia sufferer without treatment, or one using BZs to alleviate sleep difficulties.