Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression

Depression Clinical Trial

Official title:

Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02206386
• Other study ID #: R01MH096441
• Secondary ID: R01MH096441
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 25, 2014
• Last updated: July 30, 2014
• Start date: January 2013
• Est. completion date: June 2017

Study information

• Verified date: July 2014
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7800
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• MHTraining-Net
See Arm Description for more details.
• Enhanced Support
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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bruce ML, Raue PJ, Sheeran T, Reilly C, Pomerantz JC, Meyers BS, Weinberger MI, Zukowski D. Depression Care for Patients at Home (Depression CAREPATH): home care depression care management protocol, part 2. Home Healthc Nurse. 2011 Sep;29(8):480-9. doi: 10.1097/NHH.0b013e318229d75b. — View Citation

Bruce ML, Sheeran T, Raue PJ, Reilly CF, Greenberg RL, Pomerantz JC, Meyers BS, Weinberger MI, Johnston CL. Depression care for patients at home (Depression CAREPATH): intervention development and implementation, part 1. Home Healthc Nurse. 2011 Jul-Aug;29(7):416-26. doi: 10.1097/NHH.0b013e31821fe9f7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).	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)	No
Secondary	Patient reduction in depression symptoms	Patient Health Questionnaire (two item version and nine item version)	one episode of care (60 days)	No