Reliability and Validity of SymTrak, a Multi-Domain Tool for Monitoring Symptoms of Older Adults with Multiple Chronic Conditions.

BACKGROUND: A reliable and valid clinically practical multi-domain self-report and caregiver-report tool is needed for tracking actionable symptoms in primary care for elderly patients with multiple chronic conditions (MCCs). OBJECTIVE: Assess internal consistency reliability, test-retest reliability, construct validity, and sensitivity to change for SymTrak. DESIGN AND PARTICIPANTS: Among 600 (200 patient-caregiver dyads, 200 patients without an identified caregiver) participants, SymTrak was telephone interviewer-administered at baseline and 3-month follow-up, and at 24 h post-baseline for assessing test-retest reliability in a random subsample of 180 (60 dyads, 60 individual patients) participants. MAIN MEASURES: Demographic questions, SymTrak, Health Utility Index Mark 3 (HUI3). KEY RESULTS: Exploratory factor analysis indicated a single dominant dimension for SymTrak items for both patients and caregivers. Coefficient alpha and 24-h test-retest reliability, respectively, were high for the 23-item SymTrak total score for both patient-reported (0.85; 0.87) and caregiver-reported (0.86; 0.91) scores. Construct validity was supported by monotone decreasing relationships between the mean of SymTrak total scores across the poor-to-excellent categories of physical and emotional general health, and by high correlations with HUI3 overall utility score, even after adjusting for demographic covariates (standardized linear regression coefficient = - 0.84 for patients; - 0.70 for caregivers). Three-month change in the SymTrak total score was sensitive to detecting criterion standard 3-month reliable change categories (Improved, Stable, Declined) in HUI3-based health-related quality of life, especially for caregiver-reported scores. CONCLUSIONS: SymTrak demonstrates good internal consistency and test-retest reliability, construct validity, and sensitivity to change over a 3-month period, supporting its use for monitoring symptoms for older adults with MCCs.

Development and Feasibility of SymTrak, aMulti-domain Tool for Monitoring Symptoms of Older Adults in Primary Care.

BACKGROUND: A clinically practical, brief, user-friendly, multi-domain self-report and caregiver-report tool is needed for tracking actionable symptoms in primary care for elderly patients with multiple chronic conditions (MCCs). OBJECTIVE: Develop and assess usability, administration time, and internal reliability of SymTrak. DESIGN AND PARTICIPANTS: Phase I: legacy instruments, content validity, analyses of existing data, focus groups (physicians, nurses, patients, informal caregivers), and Think Aloud interviews (patients, caregivers) were used to develop SymTrak. Phase II (pilot feasibility study): 81 (27 patient-caregiver dyads, 27 patients without an identified caregiver) participants were self-administered SymTrak in clinic. MAIN MEASURES: SymTrak and demographic questions. KEY RESULTS: Consistent themes emerged from phase I focus groups. Ambiguous wording was corrected with Think Aloud feedback. In phase II, patients and caregivers preferred circling words instead of numbers for item response options. SymTrak self-administration completion time in clinic was brief; mean was 2.4, 3.0, and 3.3 min for the finalized circlingwords version, respectively, for caregivers, dyadic patients, and patients without a caregiver; and the maximum was 6.2 min for any participant. Usability questionnaire ratings were high. Cronbach's alpha for the SymTrak 23-item total score was 0.86, 0.79, and 0.81 for caregivers, dyadic patients, and patients without a caregiver, respectively. CONCLUSIONS: SymTrak demonstrates content validity, positive qualitative findings, high perceived usability, brief self-administered completion time, and good internal reliability.

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

BACKGROUND: Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. METHODS: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. DISCUSSION: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.

Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial.

BACKGROUND: Patients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function. A mobile, collaborative critical care model may enhance the recovery of ARF survivors. METHODS: The Mobile Critical Care Recovery Program (m-CCRP) study is a two arm, randomized clinical trial. We will randomize 620 patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation in a 1:1 ratio to one of two arms (310 patients per arm) - m-CCRP intervention versus attention control. Those in the intervention group will meet with a care coordinator after hospital discharge in predetermined intervals to aid in the recovery process. Baseline assessments and personalized goal setting will be used to develop an individualized care plan for each patient after discussion with an interdisciplinary team. The attention control arm will receive printed material and telephone reminders emphasizing mobility and management of chronic conditions. Duration of the intervention and follow-up is 12 months post-randomization. Our primary aim is to assess the efficacy of m-CCRP in improving the quality of life of ARF survivors at 12 months. Secondary aims of the study are to evaluate the efficacy of m-CCRP in improving function (cognitive, physical, and psychological) of ARF survivors and to determine the efficacy of m-CCRP in reducing acute healthcare utilization. DISCUSSION: The proposed randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost. We have developed a collaborative critical care model to promote ARF survivors' recovery from the physical, psychological, and cognitive impacts of critical illness. In contrast to a single disease focus and clinic-based access, m-CCRP represents a comprehensive, accessible, mobile, ahead of the curve intervention, focused on the multiple aspects of the unique recovery needs of ARF survivors. TRIAL REGISTRATION: NCT03053245 , clinicaltrials.gov, registered February 1, 2017.

Acceptability and Results of Dementia Screening Among Older Adults in the United States.

OBJECTIVES: To measure older adults acceptability of dementia screening and assess screening test results of a racially diverse sample of older primary care patients in the United States. DESIGN: Cross-sectional study of primary care patients aged 65 and older. SETTING: Urban and suburban primary care clinics in Indianapolis, Indiana, in 2008 to 2009. PARTICIPANTS: Nine hundred fifty-four primary care patients without a documented diagnosis of dementia. MEASUREMENTS: Community Screening Instrument for Dementia, the Mini-Mental State Examination, and the Telephone Instrument for Cognitive Screening. RESULTS: Of the 954 study participants who consented to participate, 748 agreed to be screened for dementia and 206 refused screening. The overall response rate was 78.4%. The positive screen rate of the sample who agreed to screening was 10.2%. After adjusting for demographic differences the following characteristics were still associated with increased likelihood of screening positive for dementia: age, male sex, and lower education. Patients who believed that they had more memory problems than other people of their age were also more likely to screen positive for dementia. CONCLUSION: Age and perceived problems with memory are associated with screening positive for dementia in primary care.

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial.

BACKGROUND: Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. METHODS/DESIGN: The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days. DISCUSSION: DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.

The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial.

BACKGROUND: Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care. Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening. This trial seeks to fill this gap and contribute information about the benefits, harms, and costs of routine screening for dementia in primary care. METHODS/DESIGN: Single-blinded, parallel, randomized controlled clinical trial with 1:1 allocation. A total of 4,000 individuals aged ≥65 years without a diagnosis of dementia, cognitive impairment, or serious mental illness receiving care at primary care practices within two cities in Indiana. Subjects will be randomized to either i) screening for dementia using the Memory Impairment Screen Telephone version or ii) no screening for dementia. Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression. Research assistants will administer the 15-item Health Utility Index, Patient Health Questionnaire, Generalized Anxiety Disorder Scale, and Medical Outcomes Study at baseline, 1, 6, and 12 months. Information about advanced care planning will be collected at baseline and 12 months. All enrollees' medical records will be reviewed to collect data on health care utilization and costs. DISCUSSION: We have two primary hypotheses; first, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening. Second, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health Questionnaire and Generalized Anxiety Disorder Scale scales. Our secondary hypothesis is that screened subjects will have an Incremental Cost-Effectiveness Ratio below the maximum acceptable threshold of $60,000 per quality adjusted life year saved at 12 months. TRIAL REGISTRATION: Ongoing; registered on September 19, 2012. ClinicalTrials.gov Identifier: 2012 NCT01699503.

Bladder buzz: the effect of a 6-week evidence-based staff education program on knowledge and attitudes regarding urinary incontinence in a nursing home.

BACKGROUND: Research shows that there is a basic gap in the knowledge of nursing home staff about urinary incontinence and the previous societal belief that urinary incontinence is a normal part of aging. This study examines the knowledge of nursing home staff about the types and treatment of urinary incontinence as well as attitudes toward urinary incontinence. METHODS: A quasi-experimental, within-subject, longitudinal pretest/posttest design was used. Nursing home staff members received a 6-week educational intervention on the types and treatment of urinary incontinence and attitudes toward urinary incontinence. RESULTS: Changes in knowledge about the types of urinary incontinence showed statistical significance for stress (p < .001), functional (p < .003), and overflow (p < .00) urinary incontinence. Changes in attitudes toward urinary incontinence showed statistical significance (p < .000). Changes in staff knowledge of the assessment and treatment of urinary incontinence did not reach statistical significance. CONCLUSION: This study showed that creative, evidence-based educational programming can improve staff knowledge about urinary incontinence and change staff attitudes toward urinary incontinence. Further research is needed on staff knowledge about the assessment and treatment of urinary incontinence.