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Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression

To identify effective implementation strategies that can efficiently promote the use of evidence-based practices (EBP) across a large number of geographically dispersed, independent Home Health Agencies (HHAs). This study will use an agency-randomized design to test the effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of an evidence-based practice for geriatric depression by home healthcare agencies. The EBP is known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH protocol with its depressed patients and changes in their patients' depressive symptoms over the episode of care.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

MHTraining-Net uses a web-based platform and several long distance tools (e.g., e-learning modules, telephone or web consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking. MHTraining-Net was developed to ensure that the Depression CAREPATH (CARE for PATients at Home), specifically, and evidence-based practices, generally, can be implemented widely and successfully across independent organizations within a sector of care.

PROCEDURES: The effectiveness of MHTraining-Net on the implementation of the Depression CAREPATH will be tested in an agency-randomized trial of 160 HHAs. All HHAs are clients of Brightree (formerly CareAnyware, Inc), a software company that offers web-based point-of-care clinical management and administrative support for HHA nationwide. HHA clinicians record relevant data that is transmitted directly to Brightree for clinical and administrative purposes, including quality improvement initiatives. As part of each HHA's contract with Brightree is permission for using these data for performance enhancement research.

Brightree has already programmed Cornell's Depression CAREPATH, a depression care management protocol, into its clinical management system so that all nurses use the protocol. To promote the use of the protocol, Brightree has posted two relevant videos (archived Patient Health Questionnaire-9 training web seminar training); demonstration of how to navigate the protocol within the software) on its user education website.

Brightree will randomize HHAs to either MHTraining-Net, (N=100) or to Enhanced Support (N=60). Enhanced Support will have access to only the two training videos until the end of the study when they will be invited to MHTraining-Net. These procedures represent Brightree's typical "roll-out" approach on introducing new training and products to their client HHAs.

The study will test its hypotheses using three sets of data:

  1. Summary statistics describing the size and type of the 160 HHAs as well as their average nurse productivity over the 12 months preceding and following the study;
  2. Routinely collected administrative data on patients age >65 who screen positive for depression over one year, including Medicare-mandated assessments, medication lists, transaction files, indicators of whether the depression care management protocol was used, and Medicare case-mix adjustment and reimbursement indicators. We are using to term 'patients' to refer to a full episode of patient care, defined from the Start-of-Care date to Discharge, recognizing that a small proportion of unique individuals may have more than one full episode of care. We will not be able to identify such individuals. These data will be aggregated at the patient level in preparation for performance enhancement analyses using Brightree's routine procedures. Brightree will code the data, remove identifiers, and transmit them to Weill Cornell on a regular basis using the Weill Cornell ITS Department secure servers and protocols.
  3. Agency-level data on the use of the MHTraining-Net website (e.g., summary reports on 'hits' of each webpage) and agency-initiated contacts (telephone, email) through records maintained by Cornell project staff.

Studietyp

Interventionell

Inskrivning (Förväntat)

7800

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • White Plains, New York, Förenta staterna, 10605
        • Weill Cornell Medical College

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Geriatric patients 65 and older
  • Patients screened for depression using the Patient Health Questionnaire-2

Exclusion Criteria:

  • Geriatric patients under age 65
  • Patients who were not screened for depression using the Patient Health Questionnaire-2

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MentalHealthTraining-Net
MHTraining-Net is an implementation strategy that uses a web-based platform with several long distance tools (e.g. e-learning modules, consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking.
See Arm Description for more details.
Aktiv komparator: Enhanced Support
Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded trainings in the use of the protocol and depression screening posted by Brightree.
Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded training in the use of the protocol and depression screening posted by Brightree.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).
Tidsram: one episode (60 days)
At least one follow-up depression assessment and evidence of case coordination (e.g., contacting the patient's physician or a specialist) to evaluate treatment needs.
one episode (60 days)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient reduction in depression symptoms
Tidsram: one episode of care (60 days)
Patient Health Questionnaire (two item version and nine item version)
one episode of care (60 days)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Martha L Bruce, PhD, MPH, Weill Medical College of Cornell University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2013

Primärt slutförande (Förväntat)

1 december 2016

Avslutad studie (Förväntat)

1 juni 2017

Studieregistreringsdatum

Först inskickad

25 juli 2014

Först inskickad som uppfyllde QC-kriterierna

30 juli 2014

Första postat (Uppskatta)

1 augusti 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

1 augusti 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juli 2014

Senast verifierad

1 juli 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • R01MH096441 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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