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GAPcare: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department (GAPcare)

7 juillet 2020 mis à jour par: Elizabeth Goldberg, Rhode Island Hospital
GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that enrolls older adults who present to the Emergency Department after a fall to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.

Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.

Type d'étude

Interventionnel

Inscription (Réel)

110

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, États-Unis, 02903
        • Rhode Island Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
  • Able to communicate in English
  • Fall not due to syncope or external force (i.e., struck by car or assault)
  • Fall not due to serious illness (i.e. stroke, acute myocardial infarction)
  • Will be discharged to home, assisted living, or rehabilitation at completion of ED visit (i.e., not admitted)
  • Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)

Exclusion Criteria:

  • Unable to give informed consent due to intoxication or altered mental status
  • Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Usual care
The ED clinician will perform a standard medical evaluation. This evaluation includes a focused history and exam to identify injuries. Laboratory tests and radiologic imaging may be ordered. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The research assistant (RA) will read the CDC STEADI brochure to the patient and provide them with a printed copy at the conclusion of their visit. The RA will solicit feedback from the clinician and the patient at the conclusion of the visit using the post-visit survey.
Expérimental: Intervention
  1. ED clinician will perform standard medical evaluation, including focused history and exam to identify injuries. RA will solicit feedback from clinician and patient via post-visit survey at conclusion of visit.
  2. PT will perform services, including integrative mobility training and lower extremity strength training and recommending outpatient services/referrals. Specific assessments and treatments will be tailored to patient.
  3. Pharmacist will perform a medication review using the updated BEERS criteria and CDC's STEADI instrument and recommend changes to potential fall risk increasing medication. Recommendations will be communicated to ED treatment team.
  4. Seniors will return home with standardized checklist containing details of their assessment and action plan. The checklist addresses patient's personal risk factors for the fall and required further actions.
Comportemental: GAPcare intervention
Subjects will receive PT and pharmacist evaluation. PT will help determine whether subject may benefit from doing exercises to improve strength or balance. PT may also supply subject with an assist device. A pharmacist will ask patient about any medication they are taking and will make recommendations on how their medication could be changed to prevent falls. Pharmacists will communicate this information to subject's doctors. Subjects will receive a fall calendar for home, where they will record any falls they have after their discharge from the ED. They will receive a phone call at home asking about any recent falls and health care interactions. Study personnel will call subjects every 2 weeks for 6 months. Subjects may receive a referral for outpatient or home-based physical and occupational therapy at the end of the visit.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of Implementing Intervention in Emergency Department
Délai: 12 Months
Assess the feasibility of implementing this intervention in an ED setting. We will report enrollment, reasons for accepting or declining enrollment, and drop-out from the study using the CONSORT approach. We will compare the demographic characteristics of the GAPcare participants in both arms using Chi-square or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon's test for continuous variables, as appropriate. We will use Wilcoxon's test to compare the median ED length of stay between participants of both study arms.
12 Months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Initial efficacy
Délai: 12 Months
Determine if the GAPcare intervention versus usual care reduces subsequent falls and all-cause and fall-related ED visits and hospital admissions in the six-month follow-up. We will compare the proportion and number of falls, ED visits, and hospital admissions in each group using chi-square (proportions) and Wilcoxon's and Student's t-tests (occurrence). If sample size permits, we will conduct survival analysis to do a time-to-event analysis. Survival time will be defined as the time from randomization to the time of the first recurrent fall, next ED visit, and hospital admission. First, we will use the Kaplan-Meier method to estimate the cumulative probability of fall-free and visit-free survival time. Next, we will use the log-rank test to test differences between survival curves for the intervention vs. usual care arm. Finally, hazard ratios and 95% confidence intervals will be calculated using the Cox Proportional Hazards model.
12 Months
Feedback
Délai: 21-24 Months
We will gather feedback from clinicians and patients on the utility and barriers of the GAPcare intervention versus usual care. We will assess 1) patient satisfaction with the care delivered, 2) barriers and facilitators of the intervention, 3) suggestions for improvement, and 4) specific feedback from clinicians on the suitability of the intervention to an ED setting. Researchers will review and code each transcript independently. A consensus process will follow, in which the researchers will categorize data into common themes within each of the 4 domains.
21-24 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rhode Island Hospital

Collaborateurs

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 janvier 2018

Achèvement primaire (Réel)

29 mars 2019

Achèvement de l'étude (Réel)

31 octobre 2019

Dates d'inscription aux études

Première soumission

27 novembre 2017

Première soumission répondant aux critères de contrôle qualité

27 novembre 2017

Première publication (Réel)

4 décembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2020

Dernière vérification

1 juillet 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GAPcare
  • R03AG056349 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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