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Video-Enhanced Care Management for Medically Complex Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962687
Recruitment Status : Completed
First Posted : November 11, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE November 11, 2016
Results First Submitted Date  ICMJE February 15, 2019
Results First Posted Date  ICMJE September 13, 2019
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE May 31, 2017
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat [ Time Frame: 14 weeks ]
    Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
  • Number of Scheduled Intervention Phone or Video Calls Completed by Participants [ Time Frame: 14 weeks ]
    Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.
  • Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI [ Time Frame: 14 weeks ]
    Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
  • Acceptability of care management program for medically complex Veterans with CI [ Time Frame: 14 weeks ]
    Acceptability will be assessed using in-depth interviews with study participants (Veterans and Care Partners), primary care providers, and study staff.
  • Perceived value of video-enhanced care management for medically complex Veterans with CI [ Time Frame: 14 weeks ]
    Perceived value associated with each delivery method will be explored through questionnaires and in-depth interviews with study participants and study staff.
  • Feasibility of care management program for medically complex Veterans with CI [ Time Frame: 14 weeks ]
    Feasibility will be assessed by examining overall rates of eligibility and enrollment, attrition, adherence to nurse calls or video visits, and interview completion.
  • Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI [ Time Frame: 14 weeks ]
    Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS).
Change History Complete list of historical versions of study NCT02962687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2019)
  • Number of Participants With Hospitalizations or Emergency Department Visits [ Time Frame: 14 weeks ]
    Descriptive analysis of emergency department visits and hospitalizations in the two study arms
  • Physical Activity [ Time Frame: 14 weeks ]
    Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)
  • Quality of Life Outcome [ Time Frame: 14 weeks ]
    Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)
  • Depression [ Time Frame: 14 weeks ]
    Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
  • Social Support [ Time Frame: 14 weeks ]
    Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)
  • Anxiety [ Time Frame: 14 weeks ]
    Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
Original Other Pre-specified Outcome Measures
 (submitted: November 8, 2016)
  • Utilization - Emergency Department (ED) visits and hospitalizations [ Time Frame: 14 weeks ]
    Descriptive analysis of ED visits and hospitalizations in the two study arms
  • Physical Activity [ Time Frame: 14 weeks ]
    Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE)
  • Quality of Life Outcome [ Time Frame: 14 weeks ]
    Descriptive analysis of health-related quality of life as measured by 5 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29)
  • Depression [ Time Frame: 14 weeks ]
    Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9)
  • Social Support [ Time Frame: 14 weeks ]
    Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS)
  • Anxiety [ Time Frame: 14 weeks ]
    Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7)
 
Descriptive Information
Brief Title  ICMJE Video-Enhanced Care Management for Medically Complex Veterans
Official Title  ICMJE Video-Enhanced Care Management for Medically Complex Veterans
Brief Summary The purpose of this study is to examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with cognitive impairment, delivered via telephone or videoconferencing.
Detailed Description

BACKGROUND Older adults with complex care needs constitute a large and rapidly expanding group of Veterans receiving care within Veterans Health Administration (VHA). Medically complex older Veterans, who often have multiple chronic conditions (MCC) as well as interacting functional and psychosocial challenges, account for a disproportionate amount of health care resources. Importantly, these Veterans also experience a disproportionate amount of suffering; they have worse functional status, higher symptom burden, and spend more of their time in acute care settings such as the hospital and emergency department.

The investigators' experience and recent studies suggest that a substantial proportion of older medically complex Veterans have unrecognized cognitive impairment (CI), and this contributes to their disproportionate need for care and adverse outcomes. The Cumulative Complexity model posits that complexity results from accumulating and interacting clinical and social factors that each contribute to a patient's workload (e.g. making appointments and managing complicated medicine regimens) as well as impact a patient's capacity to perform everyday tasks including those related to health care. Imbalance between the two- i.e. workload that exceeds capacity-is a primary driver of disruptions in care and negative outcomes. Older patients with MCC, high health care utilization, and CI often find themselves in the perfect storm of complexity, simultaneously experiencing escalated workload demands in the setting of reduced capacity.

OBJECTIVES

The primary objectives of this pilot study are to:

Examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with CI, delivered via telephone or through video visits.

  • Feasibility will be examined by calculating overall rates of eligibility and enrollment, as well as rates of attrition, adherence to nurse calls or video visits, and interview completion.
  • Acceptability will be assessed using in-depth interviews with study participants (Veterans and Care Partners), primary care providers, and study staff.

Assess the usability and perceived value of video-enhanced care management, compared to telephone-based, among older Veterans with medical complexity and CI.

  • Usability of the video-enhanced program will be examined using the System Usability Scale (SUS).
  • Perceived value associated with each delivery method will be explored through questionnaires and in-depth interviews with study participants and study staff.

METHODS Veterans aged 65 or older with high medical complexity based on Care Assessment Need (CAN) score will be screened for CI using a reliable and valid instrument developed for use over the telephone. Veterans with CI, and a self-identified Care Partner, will participate in a nurse-led care management program designed to provide structured cognitively-appropriate information and support in two key areas: (1) care coordination (reduce workload) and (2) protecting cognitive health (build capacity). Evidence-based strategies to improve care coordination and promote cognitive health are enhanced by video visits that allow for improved communication between the nurse and Veteran/Care Partner, and facilitate expanded assessments of the Veteran and his/her home environment. Study measures will include the SUS, participant feedback, and measures of intervention effectiveness including health and physical function (PROMIS 29), physical activity levels (PASE), depression (PHQ-9), anxiety (GAD-7), and acute care days (hospital and ER).

ANTICIPATED IMPACT Results from this preliminary study will be used to inform the development of a randomized clinical trial to evaluate the impact of a 12-month video-enhanced care management program for medically complex older adults with CI. Given the large number of medically complex Veterans affected by unrecognized CI, it is essential that interventions targeting this population be scalable, and technology-enhanced interventions offer a way to expand the reach of new care models. Proactive recognition and management of medically complex patients is a high priority for VHA, and medically complex Veterans with CI constitute one such high risk group. The results of this study will be of high relevance to VHA, and outside VA, given the urgent need to develop innovative means of improving care for medically complex older adults.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Multimorbidity
  • Cognitive Impairments
Intervention  ICMJE
  • Behavioral: Care management via videoconference
    12-week nurse care management for medically complex Veterans with CI delivered via videoconference
  • Behavioral: Care management via telephone calls
    12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Study Arms  ICMJE
  • Experimental: Videoconference care management
    12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing
    Intervention: Behavioral: Care management via videoconference
  • Active Comparator: Telephone care management
    12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
    Intervention: Behavioral: Care management via telephone calls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Receive primary care from a Durham Veterans Affairs Medical Center (VAMC) affiliated primary care clinic (1 visit within the previous 12 months)
  • Age > or = 65
  • CAN score > or = 90
  • Valid telephone number in the medical record
  • Identifies a friend or family member that we may contact for study participation as the Care Partner
  • Telephone Instrument for Cognitive Status - modified (TICS-m) score 20-31

Exclusion Criteria:

  • Cognitive impairment or dementia (identified via ICD diagnosis codes or Primary Care Provider note in previous 2 years)
  • Enrolled in or have an active consult for a special population Patient Aligned Care Teams (PACT), e.g.:

    • GeriPACT
    • Home Based Primary Care
    • Mental Health
    • Post-Deployment, etc.
  • Serious mental illness defined as diagnosis of psychosis of any type:

    • schizophrenia
    • bipolar disorder
    • psychiatric hospitalization in the previous year
    • or current high-risk suicide flag in their Computerized Patient Record System (CPRS) medical record
  • Active substance abuse, documented in the medical record within the previous year
  • Eligible for hospice, palliative care, or prognosis of less than 6 months to live
  • Lacks decision-making capacity, documented in the medical record
  • Referred to institutional care or residing in nursing home
  • Unable to communicate on the telephone, or no telephone access for duration of study
  • Currently hospitalized or incapacitated
  • Enrolled in a study that prohibits participation in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962687
Other Study ID Numbers  ICMJE PPO 15-425
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.

Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.

No data or statistical code that could lead to re-identification of individuals will be released.

Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.

The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication.

Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.

Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan N. Hastings, MD Durham VA Medical Center, Durham, NC
PRS Account VA Office of Research and Development
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP