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Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study.

ABSTRACT: Falls remain the leading cause of injury, long-term disability, premature institutionalization, and injury-related mortality in the older adult population. Home modifications, when delivered by occupational therapists, can reduce falls among high-risk community-dwelling older adults by 39%. However, home-modification implementation is not standard practice in the United States. The goal of the Home Hazard Removal Program (HARP) study is to implement an evidence-based home modification intervention for older adults designed to reduce the incidence of falls through an aging services network.We will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who are randomized and followed for 12 months. Participants who are randomized to treatment will receive the home modification intervention provided by an occupational therapist in addition to usual care, defined as continued services from the area agency on aging. We will compare the effectiveness of the program and usual care using survival analysis with the time to the first fall over 12 months as the primary outcome of interest. Secondary outcomes include daily activity performance, fall self-efficacy, and health-related quality of life. Fidelity, dose, adherence, safety, cost, and health care utilization will also be examined in the implementation component of this study.This intervention targets an underserved, difficult to reach population of older adults. The tailored approach of the study intervention is a strength in improving adherence, as each recommendation is individualized to be acceptable to the participant. The effectiveness/implementation design of the study allows for rapid dissemination of results and implementation of the intervention in a United States social services agency.Clinicaltrials.gov identifier: NCT02392013 . Retrospectively registered on March 5, 2015.

SUBMITTER: Stark S

PROVIDER: S-EPMC5397804 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study.

Stark Susan S Somerville Emily E Keglovits Marian M Conte Jane J Li Melody M Hu Yi-Ling YL Yan Yan Y

BMC geriatrics 20170420 1

<h4>Background</h4>Falls remain the leading cause of injury, long-term disability, premature institutionalization, and injury-related mortality in the older adult population. Home modifications, when delivered by occupational therapists, can reduce falls among high-risk community-dwelling older adults by 39%. However, home-modification implementation is not standard practice in the United States. The goal of the Home Hazard Removal Program (HARP) study is to implement an evidence-based home modi ...[more]

PMID: 28427336

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Project description:BackgroundATDOM is the Catalan home healthcare program at primary care level. Patients in the home care program are usually frail, elderly people with multiple comorbidities. They are often polymedicated, leading to a high risk of drug-related problems (DRPs). Our hypothesis is that the pharmacist-led individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality of treatments by reducing DRPs in terms of indication, adequacy, effectiveness, and safety.MethodsAim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice.DesignPragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program.SettingPrimary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain.ParticipantsFour hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment.MeasuresEffectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician.AnalysisThe outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm.EthicsThe protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P).DiscussionIf the results of the pharmaceutical intervention are favorable, widespread implementation of the program could be possible. It could be extended to all ATDOM patients or outpatients in general. Interdisciplinary teamwork could be strengthened as a result, which would improve the healthcare continuum.Trial registrationRetrospectively registered.Clinicaltrialsgov Identifier NCT05820945; Registered 21 March, 2023.

Project description:Background overview and rationaleWe co-developed a multi-component virtual care solution (TtLIVE) for the home mechanical ventilation (HMV) population using the aTouchAway™ platform (Aetonix). The TtLIVE intervention includes (1) virtual home visits; (2) customizable care plans; (3) clinical workflows that incorporate reminders, completion of symptom profiles, and tele-monitoring; and (4) digitally secure communication via messaging, audio, and video calls; (5) Resource library including print and audiovisual material.Objectives and brief methodsOur primary objective is to evaluate the TtLIVE intervention compared to a usual care control group using an eight-center, pragmatic, parallel-group single-blind (outcome assessors) randomized controlled trial. Eligible patients are children and adults newly transitioning to HMV in Ontario, Canada. Our target sample size is 440 participants (220 each arm). Our co-primary outcomes are a number of emergency department (ED) visits in the 12 months after randomization and change in family caregiver (FC) reported Pearlin Mastery Scale score from baseline to 12 months. Secondary outcomes also measured in the 12 months post randomization include healthcare utilization measured using a hybrid Ambulatory Home Care Record (AHCR-hybrid), FC burden using the Zarit Burden Interview, and health-related quality of life using the EQ-5D. In addition, we will conduct a cost-utility analysis over a 1-year time horizon and measure process outcomes including healthcare provider time using the Care Coordination Measurement Tool. We will use qualitative interviews in a subset of study participants to understand acceptability, barriers, and facilitators to the TtLIVE intervention. We will administer the Family Experiences with Care Coordination (FECC) to interview participants. We will use Poisson regression for a number of ED visits at 12 months. We will use linear regression for the Pearlin Mastery scale score at 12 months. We will adjust for the baseline score to estimate the effect of the intervention on the primary outcomes. Analysis of secondary outcomes will employ regression, causal, and linear mixed modeling. Primary analysis will follow intention-to-treat principles. We have Research Ethics Board approval from SickKids, Children's Hospital Eastern Ontario, McMaster Children's Hospital, Children's Hospital-London Health Sciences, Sunnybrook Hospital, London Health Sciences, West Park Healthcare Centre, and Ottawa Hospital.DiscussionThis pragmatic randomized controlled single-blind trial will determine the effectiveness and cost-effectiveness of the TtLIVE virtual care solution compared to usual care while providing important data on patient and family experience, as well as process measures such as healthcare provider time to deliver the intervention.Trial registrationClinicalTrials.gov NCT04180722 . Registered on November 27, 2019.

Project description:BackgroundMultimorbidity is a major problem in Europe, increasing the need for prevention and rehabilitation programs. In Germany no guidelines have been developed that focus on patients with multiple chronic non-communicable diseases (NCDs). Benefits of physical activity (PA) and exercise in NCDs have been proven, but most interventions focus on single conditions. The evaluation of the effectiveness, efficiency and safety of PA programs in patients suffering from multiple NCDs and the feasibility of the implementation within the health care service remain open research questions.MethodsThe multi-site randomized controlled pragmatic trial includes 320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity. Participants will be recruited from general practitioners and medical specialists and randomized to standard care of a statutory health insurance or MultiPill-Exercise. Standard care includes a choice of one or a maximum of two 8- to 12-week health programs, including nutrition, exercise, relaxation or special disease management programs. MultiPill-Exercise is based on the bio-psycho-social health model, considering a person-oriented perspective in light of given individual characteristics and context factors. The 24-weeks intervention focuses on aerobic and strengthening exercises in line with the WHO PA recommendations. Psychological and pedagogical elements along with behavior change techniques are implemented to ease the initiation and maintenance of exercise participation and lifestyle change, including nutrition. Primary outcome will be short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.DiscussionResults of this trial evaluate the PA intervention program in people with multiple NCDs in a real-life scenario. It will serve as a proof of concept with the opportunity of translation into routine practice. This approach, as a multi-site RCT with its rigorous methods and standardized operating procedures for the conduction of the intervention, will allow valid conclusions for the implementation of PA interventions in people with multimorbidity.Trial registrationThe trial was registered at www.drks.de (ID: DRKS00025033 ) on 30th September 2021.

Project description:BackgroundExergame-based motor-cognitive training in older adults has been associated with improvements in physical, cognitive, and psychological functioning. The novel Cocare system (Dividat GmbH), developed through a user-centered design process, allows motor-cognitive training in a telerehabilitation setting. It includes (1) a stationary stepping platform for supervised exergame training (Dividat Senso; Dividat GmbH), (2) a home-based version (Dividat Senso Flex, which is a rollable pressure-sensitive mat; Dividat GmbH), (3) an assessment system (including motor-cognitive tests), and (4) a rehabilitation cockpit for remote training supervision and management.ObjectiveThe aim of this study is to test the feasibility and effectiveness of this novel training system.MethodsA total of 180 older adults from Switzerland, Italy, and Cyprus aged ≥60 years with a prescription for rehabilitation are randomly allocated to an intervention group or a control group. Both groups continue with their usual care, whereas participants in the intervention group additionally perform a 2-week supervised exergame training program at rehabilitation centers, followed by a 10-week home training program under remote supervision. The assessment system is used to indicate the start level of each participant, and, in both intervention periods, standardized progression rules are applied. The measures of feasibility include adherence, attrition, exergame enjoyment, willingness to perform such a training program, and the number and types of help requests. Effectiveness is assessed in terms of cognitive and physical functioning, balance confidence, and quality of life.ResultsData collection started in February 2023 and is ongoing. Final measurements are expected to be performed in January 2024.ConclusionsOwing to the user-centered design approach, the Cocare system is expected to be user-friendly and offers several novel features to cover the whole continuum of care. This pragmatic trial will provide valuable information regarding final necessary adaptations and subsequent implementation efforts.Trial registrationClinicalTrials.gov NCT05751551; https://www.clinicaltrials.gov/study/NCT05751551.International registered report identifier (irrid)DERR1-10.2196/49377.

Project description:BACKGROUND:The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS:PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS:In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS:Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.

Project description:BackgroundDelays in starting physical therapy after hospital discharge worsen deconditioning in older adults. Intervening quickly can minimize the negative effects of deconditioning. Telerehabilitation is a strategy that increases access to rehabilitation, improves clinical outcomes, and reduces costs. This paper presents the protocol for a pragmatic clinical trial that aims to determine the effectiveness and cost-effectiveness of a multi-component intervention offered by telerehabilitation for discharged older adults awaiting physical therapy for any specific medical condition.MethodsThis is a pragmatic randomized controlled clinical trial with two groups: telerehabilitation and control. Participants (n=230) will be recruited among individuals discharged from hospitals who are in the public healthcare system physical therapy waiting lists. The telerehabilitation group will receive a smartphone app with a personalized program (based on individual's functional ability) of resistance, balance, and daily activity training exercises. The intervention will be implemented at the individuals' homes. This group will be monitored weekly by phone and monthly through a face-to-face meeting until they start physical therapy. The control group will adhere to the public healthcare system's usual flow and will be monitored weekly by telephone until they start physical therapy. The primary outcome will be a physical function (Timed Up and Go and 30-s Chair Stand Test). The measurements will take place in baseline, start, and discharge of outpatient physical therapy. The economic evaluations will be performed from the perspective of society and the Brazilian public healthcare system.DiscussionThe study will produce evidence on the effectiveness and cost-effectiveness of multi-component telerehabilitation intervention for discharged older adult patients awaiting physical therapy, providing input that can aid the implementation of similar proposals in other patient groups.Trial registrationBrazilian Registry of Clinical Trials (ReBEC), RBR-9243v7 . Registered on 24 August 2020.

Project description:INTRODUCTION:Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person's needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study. METHODS AND ANALYSIS:A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme. ETHICS AND DISSEMINATION:Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.

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Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study.

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Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study.

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