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      Reducing disability via a family centered intervention for acutely ill persons with Alzheimer’s disease and related dementias: protocol of a cluster-randomized controlled trial (Fam-FFC study)

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          Abstract

          Background

          Hospitalized older persons with Alzheimer’s disease and related dementias are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, environmental, policy, and care practices that restrict physical and cognitive activity, lack of family involvement and limited staff knowledge of dementia care. We have developed a theory-based intervention, Family centered Function-focused Care, that incorporates an educational empowerment model for family caregivers (FCGs) provided within a social-ecological framework to promote specialized care to patients with dementia during hospitalization and the 60-day post-acute period. Primary aims are to test the efficacy of the intervention in improving physical and cognitive recovery in hospitalized persons living with Alzheimer’s disease and related dementias (ADRD) and improving FCG preparedness and experiences.

          Method

          We will implement Family centered Function-focused Care in a cluster-randomized trial of 438 patient/FCG dyads in six hospital units randomized within three hospitals. We hypothesize that patients who receive the intervention will demonstrate better physical function, less delirium occurrence and severity, neuropsychiatric symptoms, and depression compared to those in the control condition (Education-only). We also hypothesize that FCGs enrolled in Family centered Function-focused Care will experience increased preparedness for caregiving, and less strain, burden, and desire to institutionalize, as compared to FCGs the control group. We will also examine the costs and relative cost savings associated with the intervention and will evaluate the cultural appropriateness of Family centered Function-focused Care for families from diverse backgrounds.

          Discussion

          Our theory-based intervention makes use of real-world applicable approaches in a novel and innovative way to change the paradigm of how we currently look at acute care and post-acute transitions in persons with ADRD.

          Trial registration

          ClinicalTrials.gov, ID: NCT03046121. Registered on 8 February 2017.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2875-1) contains supplementary material, which is available to authorized users.

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          Most cited references56

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          Family caregivers of people with dementia

          Family caregivers of people with dementia, often called the invisible second patients, are critical to the quality of life of the care recipients. The effects of being a family caregiver, though sometimes positive, are generally negative, with high rates of burden and psychological morbidity as well as social isolation, physical ill-health, and financial hardship. Caregivers vulnerable to adverse effects can be identified, as can factors which ameliorate or exacerbate burden and strain. Psychosocial interventions have been demonstrated to reduce caregiver burden and depression and delay nursing home admission. Comprehensive management of the patient with dementia includes building a partnership between health professionals and family caregivers, referral to Alzheimer's Associations, and psychosocial interventions where indicated.
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            International experiences with the Hospital Anxiety and Depression Scale-A review of validation data and clinical results

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              A reengineered hospital discharge program to decrease rehospitalization: a randomized trial.

              Emergency department visits and rehospitalization are common after hospital discharge. To test the effects of an intervention designed to minimize hospital utilization after discharge. Randomized trial using block randomization of 6 and 8. Randomly arranged index cards were placed in opaque envelopes labeled consecutively with study numbers, and participants were assigned a study group by revealing the index card. General medical service at an urban, academic, safety-net hospital. 749 English-speaking hospitalized adults (mean age, 49.9 years). A nurse discharge advocate worked with patients during their hospital stay to arrange follow-up appointments, confirm medication reconciliation, and conduct patient education with an individualized instruction booklet that was sent to their primary care provider. A clinical pharmacist called patients 2 to 4 days after discharge to reinforce the discharge plan and review medications. Participants and providers were not blinded to treatment assignment. Primary outcomes were emergency department visits and hospitalizations within 30 days of discharge. Secondary outcomes were self-reported preparedness for discharge and frequency of primary care providers' follow-up within 30 days of discharge. Research staff doing follow-up were blinded to study group assignment. Participants in the intervention group (n = 370) had a lower rate of hospital utilization than those receiving usual care (n = 368) (0.314 vs. 0.451 visit per person per month; incidence rate ratio, 0.695 [95% CI, 0.515 to 0.937]; P = 0.009). The intervention was most effective among participants with hospital utilization in the 6 months before index admission (P = 0.014). Adverse events were not assessed; these data were collected but are still being analyzed. This was a single-center study in which not all potentially eligible patients could be enrolled, and outcome assessment sometimes relied on participant report. A package of discharge services reduced hospital utilization within 30 days of discharge. Agency for Healthcare Research and Quality and National Heart, Lung, and Blood Institute, National Institutes of Health.
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                Author and article information

                Contributors
                215-962-9712 , mpb40@psu.edu
                auk536@psu.edu
                resnick@umaryland.edu
                Rebecca.Trotta@uphs.upenn.edu
                jam935@psu.edu
                rhonda.belue@slu.edu
                Dleslie@phs.psu.edu
                galvinj@health.fau.edu
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                17 September 2018
                17 September 2018
                2018
                : 19
                : 496
                Affiliations
                [1 ]ISNI 0000 0001 2097 4281, GRID grid.29857.31, The Pennsylvania State University, College of Nursing, ; 306 Nursing Sciences Building, University Park, PA 16802 USA
                [2 ]ISNI 0000 0001 2175 4264, GRID grid.411024.2, University of Maryland School of Nursing, ; Baltimore, MD USA
                [3 ]ISNI 0000 0004 0435 0884, GRID grid.411115.1, Hospital of the University of Pennsylvania, ; Philadelphia, PA USA
                [4 ]ISNI 0000 0004 1936 9342, GRID grid.262962.b, St. Louis University, ; St. Louis, MO USA
                [5 ]ISNI 0000 0004 0635 0263, GRID grid.255951.f, Florida Atlantic University, ; Boca Raton, FL USA
                Author information
                http://orcid.org/0000-0003-1133-2249
                Article
                2875
                10.1186/s13063-018-2875-1
                6142366
                30223870
                9ec4cd3d-729a-4fff-89e0-0dddd17411c5
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 13 April 2018
                : 23 August 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000049, National Institute on Aging;
                Award ID: R01AG054425
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                dementia,hospitalization,post-acute,family engagement,functional recovery
                Medicine
                dementia, hospitalization, post-acute, family engagement, functional recovery

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