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A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial.

ABSTRACT: BACKGROUND AND OBJECTIVES:It is unclear how to optimally care for chronic kidney disease (CKD). This study compares a new coordinated model to usual care for CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:A randomized trial in nephrology clinics and the community included 474 patients with median estimated GFR (eGFR) 42 ml/min per 1.73 m(2) identified by laboratory-based case finding compared care coordinated by a general practitioner (controls) with care by a nurse-coordinated team including a nephrologist (intervention) for a median (interquartile range [IQR]) of 742 days. 32% were diabetic, 60% had cardiovascular disease, and proteinuria was minimal. Guided by protocols, the intervention team targeted risk factors for adverse kidney and cardiovascular outcomes. Serial eGFR and clinical events were tracked. RESULTS:The average decline in eGFR over 20 months was -1.9 ml/min per 1.73 m(2). eGFR declined by ?4 ml/min per 1.73 m(2) within 20 months in 28 (17%) intervention patients versus 23 (13.9%) control patients. Control of BP, LDL, and diabetes were comparable across groups. In the intervention group there was a trend to greater use of renin-angiotensin blockers and more use of statins in those with initial LDL >2.5 mmol/L. Treatment was rarely required for anemia, acidosis, or disordered mineral metabolism. Clinical events occurred in 5.2% per year. CONCLUSIONS:Patients with stage 3/4 CKD identified through community laboratories largely had nonprogressive kidney disease but had cardiovascular risk. Over a median of 24 months, the nurse-coordinated team did not affect rate of GFR decline or control of most risk factors compared with usual care.

SUBMITTER: Barrett BJ

PROVIDER: S-EPMC3109918 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial.

Barrett Brendan J BJ Garg Amit X AX Goeree Ron R Levin Adeera A Molzahn Anita A Rigatto Claudio C Singer Joel J Soltys George G Soroka Steven S Ayers Dieter D Parfrey Patrick S PS

Clinical journal of the American Society of Nephrology : CJASN 20110526 6

<h4>Background and objectives</h4>It is unclear how to optimally care for chronic kidney disease (CKD). This study compares a new coordinated model to usual care for CKD.<h4>Design, setting, participants, & measurements</h4>A randomized trial in nephrology clinics and the community included 474 patients with median estimated GFR (eGFR) 42 ml/min per 1.73 m(2) identified by laboratory-based case finding compared care coordinated by a general practitioner (controls) with care by a nurse-coordinate ...[more]

PMID: 21617090

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Project description:BackgroundTechnology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic stroke patients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care.MethodsIn this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic stroke participants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes.ResultsIn total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014).ConclusionsTechnology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance.Trial registrationClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554 , date of Registration: 13 July 2020.

Project description:Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care.An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness.The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs.This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings.ClinicalTrials.gov (NCT00997451, March 28, 2009).

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Project description:BackgroundEndometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP.MethodsWe will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation.DiscussionThis is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617000053325 (http://www.ANZCTR.org.au/ACTRN12617000053325.aspx).

Project description:BackgroundResearch studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient satisfaction with care (Gomes B, et al. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013(6):CD00776) (World Health Organization. Palliative Care. Published 2020.). While 76% of patients who need palliative care live in limited-resource countries, access to high quality palliative services in these countries is minimal (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care (2nd ed). 2020.). In 2014 the Worldwide Hospice Palliative Care Alliance, with strong endorsement by the WHO, released the Palliative Care Toolkit to provide a training and implementation toolkit for empowering community members to deliver palliative care in resource poor settings (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care at the End of Life. Geneva, Switzerland 2014.). They encouraged researchers and public health practitioners to conduct rigorous evaluation of the toolkit in diverse settings and contexts. To address this need, we will conduct a pilot randomized controlled trial (RCT) to examine implementation and explore potential effect of an intervention based upon the Palliative Care Toolkit, as adapted and used by community health workers (CHWs) working with a cancer center in Kolkata, India to deliver home-based palliative care for rural patients.MethodsUtilizing a randomized controlled trial design, intervention patients (n = 45) receive home-based palliative services (Pal-Care) delivered by community health workers (CHWs), with comparison against a control group of patients (n = 45) who receive usual cancer-center-based palliative services. Primary outcome measures include evaluation of CHW training outcomes, roles and responsibilities of the CHWS and how they assist patients, trial recruitment, stakeholder perceptions of the intervention, and fidelity to study protocol. Secondary outcomes measure patient self-report of health-related quality of life, symptom burden, palliative needs and patient care experience, outcomes The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention (Gaglio B, et al. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38?46.). Data will be analyzed in SAS. All measures will be evaluated overall and by patient age, gender and cancer type and by CHW caseload.DiscussionPal-Care is a RCT funded by the NCI to explore utilization of CHWs to deliver a home-based palliative care intervention built upon the WHO Palliative Care toolkit (PCT), as compared to a usual care control group. The long-term goal of this research is to develop an effective and sustainable model for delivering home-based palliative care for cancer patients in underserved areas.Trial registration (trn)ClinicalTrials.gov ID# NCT04972630.

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A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial.

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A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial.

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