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DepressionNCT02206386

Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression

A study testing MHTraining-Net and Enhanced Support in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Depression
What is being tested?
MHTraining-Net and Enhanced Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,800 participants
Where
1 siteUnited States
Study dates
Jan 2013to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Weill Cornell Medical College

    White Plains, New York, 10605

Other trials in United States

About this study

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.

Read the 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:

  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.
Conditions
Depression
Being tested
MHTraining-Net, Enhanced Support
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MHTraining-NetOther

    See Arm Description for more details.

  • Enhanced SupportOther

    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.

Study groups in NCT02206386
Study groupRoleWhat they receive
MentalHealthTraining-NetExperimentalMHTraining-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.
Receives: Other: MHTraining-Net
Enhanced SupportActive comparatorNurses 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.
Receives: Other: Enhanced Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one episode (60 days)

Secondary outcomes (1)
  1. Patient reduction in depression symptoms

    Patient Health Questionnaire (two item version and nine item version)

    Measured: one episode of care (60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
7,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02206386
Sponsor's protocol ID
R01MH096441
Other IDs
R01MH096441
Status last verified
Jul 2014
First submitted
25 Jul 2014
Last updated
1 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21881429
  • 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.

    PubMed 21716043

Questions about this trial

What is this clinical trial studying?

A study testing MHTraining-Net and Enhanced Support in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nurse adherence to the depression care management protocol (Depression CAREPATH intervention). (time frame: one episode (60 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206386, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.

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