Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MHTraining-Net
Enhanced Support
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MentalHealthTraining-Net
Enhanced Support
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient reduction in depression symptoms
Patient Health Questionnaire (two item version and nine item version)
Full Information
NCT ID
NCT02206386
First Posted
July 25, 2014
Last Updated
July 30, 2014
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02206386
Brief Title
Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression
Official Title
Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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:
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;
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MentalHealthTraining-Net
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MHTraining-Net
Intervention Description
See Arm Description for more details.
Intervention Type
Other
Intervention Name(s)
Enhanced Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).
Description
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.
Time Frame
one episode (60 days)
Secondary Outcome Measure Information:
Title
Patient reduction in depression symptoms
Description
Patient Health Questionnaire (two item version and nine item version)
Time Frame
one episode of care (60 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha L Bruce, PhD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21881429
Citation
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.
Results Reference
background
PubMed Identifier
21716043
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.
Results Reference
background
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Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression
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