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Care Coordination in Oncology, Quality Among Patients With Lung Cancer and Their Caregivers

5 avril 2019 mis à jour par: Geisinger Clinic

Exploratory Evaluation of Family Caregiver Application (FCA) on Quality Among Persons With Lung Cancer and Their Family Caregivers

The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Participation in the study involves completion of surveys, permission to review information from the patient's electronic health record, and for some enrollment in the care coordination tool called Harmonized Care. Geisinger oncology care providers who have patients enrolled the study will be invited for interviews.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The case-matched controlled design, exploratory evaluation study will look at how exposure to a care coordination tool impacts quality and performance indicators associated with oncology care from the perspective of patients, caregivers, and providers.

Geisinger research staff will recruit lung cancer patients and their caregivers across three Geisinger locations: Geisinger Medical Center (GMC), Geisinger Wyoming Valley Medical Center (GWV) and Geisinger Community Medical Center (GCMC). GMC will serve as the intervention site and GWV and GCMC as control sites.

Eligible participants will be identified by the study staff through the electronic health record as well as through clinical staff and approached in the oncology clinic as part of a schedule office visit and/or treatment. For the purpose of study awareness, informational flyers will be available to patients in the exam rooms, waiting rooms, and through Oncology Care's Multi-Disciplinary clinic. Participants will asked to identify a caregiver who will participate in the study as well, however this is not required.

Case dyads enrolled at the intervention site (GMC) will be asked to complete a survey when they join the study and at the end of the study. Participants will also be asked to enroll in the care coordination tool, a health information solution that integrates the patient, caregiver, and clinical data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to give permission to the study team to access their health information via the e electronic health record. Participants will be in the research study for about 8-10 weeks.

Control dyads enrolled at the control site (GWV and GCMC) will be asked to complete a survey eight weeks after consenting to participate. Patients will be asked to give permission to the study team to access their health information via the electronic health record. Participants will be in the research study for about 8-10 weeks.

The study will also enroll oncology care providers within the Medical Oncology or Radiation Oncology departments at GMC and who have patients enrolled in the study. Providers will be asked to participate in a 30-minute interview to get their feedback and insights on the care coordination tool.

Type d'étude

Interventionnel

Inscription (Réel)

57

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
    • Pennsylvania
      • Danville, Pennsylvania, États-Unis, 17822
        • Geisinger Health System

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Patients:

  • Patients who are 18 years of age or older and diagnosed with lung cancer who 1) are scheduled to start Oncology Care (chemo and/or radiation-therapies) OR 2) on active Oncology Care and recently started within 3 weeks (<27 days for experimental arm; <56 days control arm)
  • Receive care at GMC, GWV, or GCMC
  • English-speaking
  • Established/intends to establish a MyGeisinger Account (cases only)

Caregivers:

  • Recognized/intends to be recognized as proxy for patient's MyGeisinger Account (cases only)
  • English-speaking

Providers:

- Any health care provider within Medical Oncology or Radiation Oncology at GMC, where care coordination tool is standard of care, who has a patient enrolled.

Exclusion Criteria:

Patients:

  • Patients who are not diagnosed with lung cancer.
  • Patients who are diagnosed with lung cancer and are on active Oncology Care exceeding 3 weeks (>27 days experimental arm; >56 days control arm).

Providers:

  • Any healthcare provider not within the Medical Oncology or Radiation Oncology departments.
  • Any healthcare provider within Medical Oncology or Radiation Oncology who does not have a patient enrolled (Case Dyad).

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: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Care coordination patients, caregivers
Patients and caregivers enroll in using care coordination tool during oncology care and treatment.
Autre: Care coordination tool
Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.
Aucune intervention: Standard of care patients, caregivers
Patients and caregivers receive oncology care and treatment.
Expérimental: Oncology Care Providers
Oncology care providers with patients enrolled in care coordination tool.
Autre: Care coordination tool
Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient Satisfaction
Délai: 8 weeks
To evaluate the difference in patient satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure.To evaluate the association of the change in patient satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.
8 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Caregiver Satisfaction
Délai: 8 weeks
To evaluate the difference in caregiver satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure. To evaluate the association of the change in caregiver satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.
8 weeks
Patient Quality of Life
Délai: 8 weeks
To evaluate the difference in patient quality of life associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of quality of life associated with FCA exposure.To evaluate the association of the change in patient quality of life associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in quality of life perceptions based on role.
8 weeks
Caregiver Quality of Life
Délai: 8 weeks
To evaluate the difference in caregiver quality of life associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of quality of life associated with FCA exposure. To evaluate the association of the change in caregiver quality of life associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in quality of life perceptions based on role.
8 weeks
Family Centered Care
Délai: 8 weeks
To evaluate the difference in family centered care associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient and caregiver analyses will also be performed to detect role-level differences in perceptions of family centered care associated with FCA exposure. To evaluate the association of the change in family centered care associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in family centered care perceptions based on role.
8 weeks
Patient Experience
Délai: 8 weeks
To evaluate the difference in patient experience associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of experience associated with FCA exposure.To evaluate the association of the change in patient experience associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in experience perceptions based on role.
8 weeks
Caregiver Burden
Délai: 8 weeks
To evaluate the difference in caregiver burden associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of burden associated with FCA exposure.To evaluate the association of the change in caregiver burden associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. To evaluate the association of the change in caregiver burden associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution.
8 weeks

Collaborateurs et enquêteurs

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

Parrainer

Geisinger Clinic

Collaborateurs

Merck Sharp & Dohme LLC

Les enquêteurs

  • Chercheur principal: Lisa Bailey-Davis, DEd, RD, Geisinger Clinic

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)

4 juin 2018

Achèvement primaire (Réel)

28 février 2019

Achèvement de l'étude (Réel)

31 mars 2019

Dates d'inscription aux études

Première soumission

11 septembre 2018

Première soumission répondant aux critères de contrôle qualité

27 septembre 2018

Première publication (Réel)

3 octobre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 avril 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 avril 2019

Dernière vérification

1 avril 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2018-0172

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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