Dataset Information

Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.

ABSTRACT: BACKGROUND:Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identify risk factors for PU after SCI, and find an effective and less time-consuming treatment for the condition among different available methods for follow-up. METHOD/DESIGN:The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design. The study will identify possible risk factors for acquiring PU. A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014. In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial (RCT) where we will compare outpatient SCI follow-up in a hospital versus outpatient follow-up from the patient's home, using telemedicine (teleSCI) interventions. We will compare the healing of the PU in the two groups (usual care versus teleSCI). The Tissue, Infection, Moisture Edge (TIME) registration form, the Photographic Wound Assessment Tool (PWAT) and the change in the ulcer size will be used to monitor the healing. Changes in health-related quality of life (HRQoL) and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale (EQ-5D), the generic Medical Outcomes Study 12-item Short Form Health Survey (SF-12) modified version, the International Spinal Cord Injury Quality of Life Data set (ISCI-QoL Data set), and the Spinal Cord Independence Measure scale, version III (SCIM III). In addition to primary outcome measures, a cost-benefit evaluation and an assessment of patient satisfaction and participation will be performed, using customized questionnaires. DISCUSSION:The first part of the research project will reveal the epidemiology of PU after SCI, and explore the risk factors. This part enables further prevention of PU after SCI and this information will be used in the follow-up RCT. Videoconferencing in the outpatient follow-up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration, communication and competence exchange among participants of the health care services. Our research protocol allows comparing methods for interaction between medical specialists at hospitals, local caregivers in the community, next of kin, and persons with SCI and PU. The RCT should identify advantages as well as challenges in the management of PU in different follow-up settings. This study aims to identify risk factors for PU after SCI, and find an effective and less time consuming treatment for the condition among different available methods for follow- up. TRIAL REGISTRATION:1. www.ClinicalTrials.gov , ID: NCT02800915 , last update 9 October 2017. 2. The National Regional Ethical Committee (REC) 2014/ 684/ REK-Nord. https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=469163&p_parent_id=473640&_ikbLanguageCode=n 3. https://app.cristin.no/projects/show.jsf?id=545284 4. https://www.sunnaas.no/kliniske-studier/bruk-av-telemedisin-som-virkemiddel-til-samhandling-i-poliklinisk-oppfolging-av-pasienter-med-ryggmargsskade-og-trykksar.

SUBMITTER: Irgens I

PROVIDER: S-EPMC6346520 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.

Irgens Ingebjørg I Hoff Jana M JM Sørli Hilde H Haugland Hanne H Stanghelle Johan K JK Rekand Tiina T

Trials 20190124 1

<h4>Background</h4>Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identify risk factors for PU after SCI, and find an effective and less time-consuming treatment for the condition among different available methods for follow-up.<h4>Method/desig ...[more]

PMID: 30678710

Similar Datasets

Project description:BACKGROUND:Coronary artery disease (CAD) is among the main causes of hospitalization and death worldwide, therefore, the implementation of programs to reduce its impact is necessary. Supervised cardiac rehabilitation has been shown to have positive effects on CAD control. However, there are barriers to patient participation in the traditional, face-to-face cardiac rehabilitation programs, mainly in low-resource environments. OBJECTIVE:This study aimed to verify patient compliance to a home-based cardiac rehabilitation program, which includes unsupervised health education and physical exercises, guided by telephone. Moreover, we compare this new method to the traditional supervised cardiac rehabilitation offered in most hospital centers. METHODS:We present here a two-arm, single-blinded, and randomized controlled design protocol, which compares the traditional cardiac rehabilitation (CenterRehab) with the home-based cardiac rehabilitation (Home-Based) in 72 patients affected by CAD. The primary outcome is the compliance to the cardiac rehabilitation sessions. The secondary outcomes (to evaluate effectiveness) include measurable variables such as functional capacity, CAD risk factors (blood pressure, waist circumference, glycemic, cholesterol levels, depressive symptoms, and the level of physical activity), the patient's quality of life, the disease knowledge, and the morbidity rate. Parameters such as the program cost and the usability will also be evaluated. The programs will last 12 weeks, with a total of 60 rehabilitation and 6 educational sessions. Patients of the CenterRehab program will participate in 24 supervised sessions and 36 home sessions, while the patients of the Home-Based program will participate in 2 supervised sessions and 58 home sessions, guided by telephone. After the 12-week period all participants will be recommended to continue practicing physical exercises at home or at a community center, and they will be invited for re-evaluation after 3 months. The outcomes will be evaluated at baseline, and after 3 and 6 months. RESULTS:Participants are currently being recruited for the trial. Data collection is anticipated to be completed by October 2019. CONCLUSIONS:This is the first study in Brazil comparing the traditional cardiac rehabilitation approach with a novel, home-based protocol that uses an accessible and low-cost technology. If positive results are obtained, the study will contribute to establish a new and viable model of cardiac rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov NCT03605992; https://clinicaltrials.gov/ct2/show/NCT03605992. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13901.

Project description:BackgroundHospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking.ObjectiveDetermine if home hospital care reduces cost while maintaining quality, safety, and patient experience.DesignRandomized controlled trial.ParticipantsAdults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma.InterventionHome hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing.Main measuresPrimary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience.Key resultsNine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups.ConclusionsThe use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Project description:Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement.We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points.For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans.Clinical Trials.gov Identifier: NCT00384748.

Project description:Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function.This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required.The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty.U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

Project description:BackgroundBetween 30% and 60% of people who have been infected with COVID-19 still had symptoms 3 months after the start of the disease. Prescribing a pulmonary rehabilitation program in rehabilitation facilities for post COVID-19 patients could help alleviate the symptoms. However, rehabilitation facilities known to provide good quality care to COVID-19 patients and all other patients, could become saturated by the rise in cases. Home-based rehabilitation is a potential solution that could be sustainable in the long term to avoid this saturation and/or a very long waiting list for patients.AimThe aim of this study was to investigate whether home-based rehabilitation would have similar effects compared to inpatient rehabilitation on physical and respiratory variables in post COVID-19 patients.DesignThis is a randomized controlled trial.SettingPulmonary rehabilitation facility.PopulationSeventeen post COVID-19 patients were randomized into two groups: inpatient pulmonary rehabilitation (IPR) or home-based pulmonary rehabilitation (HPR).MethodsThe comparison of the two rehabilitation methods relied on questionnaires, physical tests and the evaluation of several respiratory parameters. A 2-way Analysis of Variance (ANOVA) with repeated measures was performed to assess the effects of time (pre- vs. post-rehabilitation), group (IPR vs. HPR) and their interaction for all parameters.ResultsThe main result of this study is that distance covered in the 6MWT (6MWD) shows significant improvements, between pre- and postrehabilitation program in both groups (+95 m in IPR group vs.+72 m in HPR group, P<0.001) with no significant interaction between time and group (P=0.420).ConclusionsThese results suggest that home-based pulmonary rehabilitation would be as efficient as IPR to decrease physical sequelae in post COVID-19 patients.Clinical rehabilitation impactIt is possible to suggest both methods (home-based rehabilitation or inpatient pulmonary rehabilitation) according to the specificities of each patient and depending on hospital saturation. The choice of one or the other method should not be made to the detriment of the patient.

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.

Project description:BackgroundSubstitutive hospital-level care in a patient's home ("home hospital") has been shown to lower cost, utilization, and readmission compared to traditional hospital care. However, patients' perspectives to help explain how and why interventions like home hospital accomplish many of these results are lacking.ObjectiveElucidate and explain patient perceptions of home hospital versus traditional hospital care to better describe the different perceptions of care in both settings.DesignQualitative evaluation of a randomized controlled trial.Participants36 hospitalized patients (19 home; 17 control).InterventionTraditional hospital ("control") versus home hospital ("home"), including nurse and physician home visits, intravenous medications, remote monitoring, video communication, and point-of-care testing.ApproachWe conducted a thematic content analysis of semi-structured interviews. Team members developed a coding structure through a multiphase approach, utilizing a constant comparative method.Key resultsThemes clustered around 3 domains: clinician factors, factors promoting healing, and systems factors. Clinician factors were similar in both groups; both described beneficial interactions with clinical staff; however, home patients identified greater continuity of care. For factors promoting healing, home patients described a locus of control surrounding their sleep, activity, and environmental comfort that control patients lacked. For systems factors, home patients experienced more efficient processes and logistics, particularly around admission and technology use, while both noted difficulty with discharge planning.ConclusionsCompared to control patients, home patients had better experiences with their care team, had more experiences promoting healing such as better sleep and physical activity, and had better experiences with systems factors such as the admission processes. Potential explanations include continuity of care, the power and familiarity of the home, and streamlined logistics. Future improvements include enhanced care transitions and ensuring digital interfaces are usable.Trial registrationNCT03203759.

Dataset Information

Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.

Publications

Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets