Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Assess the usability and perceived value of video-enhanced care management, compared to telephone-based, among older Veterans with medical complexity and CI.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videoconference care management | Experimental | 12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing |
|
| Telephone care management | Active Comparator | 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care management via videoconference | Behavioral | 12-week nurse care management for medically complex Veterans with CI delivered via videoconference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat | Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat. | 14 weeks |
| Number of Scheduled Intervention Phone or Video Calls Completed by Participants | Feasibility will be assessed by examining rates of adherence to intervention phone/video calls. | 14 weeks |
| Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI | Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better). | 14 weeks |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospitalizations or Emergency Department Visits | Descriptive analysis of emergency department visits and hospitalizations in the two study arms | 14 weeks |
| Physical Activity |
Inclusion Criteria:
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.:
Serious mental illness defined as diagnosis of psychosis of any type:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan N. Hastings, MD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Videoconference Care Management | 12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via videoconference |
| FG001 | Telephone Care Management | 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via telephone calls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Videoconference Care Management | 12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference |
| BG001 | Telephone Care Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat | Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat. | These numbers represent the Veterans in the sample (Care Partners not analyzed) | Posted | Count of Participants | Participants | 14 weeks |
|
14 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Videoconference Care Management - Veterans | 12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Vascular disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED Visit | Infections and infestations | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
Perceived value associated with each delivery method was removed as an outcome on 2/13/19 because data are being analyzed as qualitative data; there are no quant data to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan N Hastings | Durham VA HSR&D | 919-286-6986 | susan.hastings@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 | Feb 14, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Care management via telephone calls | Behavioral | 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls |
|
Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)
| 14 weeks |
| Quality of Life Outcome | 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) | 14 weeks |
| Depression | Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better) | 14 weeks |
| Social Support | Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better) | 14 weeks |
| Anxiety | Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better) | 14 weeks |
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Race (NIH/OMB) | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Internet Use in Last Year | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Comfortable with Using the Internet | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Has Accessed Internet with Tablet Computer | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Previously Used Videochat | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
| Likely to see healthcare provider using videochat | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants). | Count of Participants | Participants |
|
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
|
|
| Primary | Number of Scheduled Intervention Phone or Video Calls Completed by Participants | Feasibility will be assessed by examining rates of adherence to intervention phone/video calls. | These number represent the Veterans in the sample (Care Partners not analyzed) | Posted | Count of Units | calls | 14 weeks | calls | calls |
|
|
|
| Primary | Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI | Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better). | The System Usability Scale was administered only to the videoconference care management Veteran participants. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Hospitalizations or Emergency Department Visits | Descriptive analysis of emergency department visits and hospitalizations in the two study arms | Utilization data was collected for Veteran participants only. | Posted | Number | participants | 14 weeks |
|
|
|
| Other Pre-specified | Physical Activity | Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better) | The PASE was administered to the Veteran participants only. | Posted | Mean | Standard Deviation | weighted sum | 14 weeks |
|
|
|
| Other Pre-specified | Quality of Life Outcome | 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) | The PROMIS subscales were administered to the Veteran participants only. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| Other Pre-specified | Depression | Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better) | The PHQ-9 was administered to the Veteran participants only. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| Other Pre-specified | Social Support | Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better) | The mMOS-SS was administered to the Veteran participants only. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| Other Pre-specified | Anxiety | Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better) | The GAD-7 was administered to the Veteran participants only. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| 4 |
| 20 |
| EG001 | Telephone Care Management - Veterans | 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls | 0 | 20 | 1 | 20 | 3 | 20 |
| EG002 | Videoconference Care Management - Care Partners | 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconference | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Telephone Care Management - Care Partners | 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls | 0 | 20 | 0 | 20 | 0 | 20 |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
|
|
| ED Visit | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
|
| ED Visit | Cardiac disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
|
| ED Visit | Psychiatric disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
|
| ED Visit | General disorders | Non-systematic Assessment | Adverse events are reported as monitored/assessed |
|
Not provided
Not provided
Not provided
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PROMIS-29 (Social Roles) |
|