Effectiveness of a Depression Care Management Initiative in Home Healthcare

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01979302
First received: September 26, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Depression in older home healthcare patients occurs very often, is typically not treated appropriately, and leads to poor health outcomes. This study tests an intervention, called "Depression Care for Patients at Home" or the Depression CAREPATH, designed to help home healthcare nurses work with the patients, their family, and their doctors in managing depression treat depression according to clinical guidelines and to manage its treatment over time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent changes in depression treatment and reduction in depressive symptoms.


Condition Intervention
Depression
Other: Depression CAREPATH
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Depression Care Management Initiative in Home Healthcare

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Depression Severity [ Time Frame: 2 week ] [ Designated as safety issue: No ]
    Assessment of depression severity using the Hamilton Depression Rating Scale


Secondary Outcome Measures:
  • Guideline Consistent change in depression treatment [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    Patient home healthcare records reviewed for evidence that patients received a change in depression treatment (e.g., antidepressant initiation, dose change, augmentation, switch)


Estimated Enrollment: 310
Study Start Date: January 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depression CAREPATH
Patients receiving care from Nurses trained in depression care management
Other: Depression CAREPATH
Nurses receive training and agency support in depression assessment and depression care management
Usual Care
Patients under the care of nurses who were trained in depression assessment and usual care
Other: Usual Care
Nurses receive training in depression assessment and review of usual care procedures.

Detailed Description:

The goal of this research is to improve depression treatment and outcomes among elderly home healthcare patients. Homecare nursing is a major source of health care for a large and growing number of medically ill or injured older adults who are homebound by illness or disability. Clinically significant depression is twice as prevalent in this patient population compared to similarly aged primary care patients. Depression can be effectively treated in older adults, and treatment guidelines have been developed to help physicians make treatment decisions for their depressed older patients. However, medical home healthcare patients rarely receive guideline-consistent treatment for depression. This research tests the effectiveness of an intervention, Depression Care for Patients at Home" (CAREPATH), on two outcomes: 1. Depression treatment (i.e., initiate treatment or have a change in treatment that is consistent with guidelines), and 2. Depressive symptoms (i.e., reduction in depressive symptoms over time). The CAREPATH protocol was designed in partnership with home healthcare providers. It includes the major elements of depression care management models that have proven effective in primary care but restructures these elements to fit the clinical needs of home healthcare patients and for consistency with home healthcare practice. The intervention itself is designed to be ecologically sensitive to maximize the feasibility and generalizability of the program. The CAREPATH Intervention is being tested within six home healthcare agencies located in Vermont/New Hampshire, New York, Pennsylvania, Michigan, Florida, and Arkansas. The design includes randomization of ~20 teams of nurses to CAREPATH or usual care. The impact of CAREPATH on depression treatment is tested with all eligible patients (N~600) using data collected routinely by all agencies as these are the kinds of data that agencies typically use for quality assurance. Depressive symptoms outcomes are tested using the Hamilton Depression Rating Scale (HDRS) collected by researcher staff from (N=300) patients who consent to in-person baseline and telephone follow-up interviews at 12, 24, and 52 weeks.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New home healthcare patient
  • Age 65 years or older
  • Depressed Mood or Anhedonia recorded by visiting nurse
  • English or Spanish speaking

Exclusion Criteria:

  • High suicide risk, i.e. intent or plan to attempt suicide in near future as defined by the suicide risk assessment.
  • Significant Cognitive Impairment: Mini-mental Status Exam below 20
  • Severe hearing impairment or aphasic
  • Life expectancy less than 6 months (CMS 485)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979302

Locations
United States, New York
Weill Cornell Medical College, Westchester Division
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Martha L Bruce, PhD, MPH Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01979302     History of Changes
Other Study ID Numbers: R01 MH082425
Study First Received: September 26, 2013
Last Updated: November 1, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Geriatric Depression
Depression Care Management
home healthcare
nurse training intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014