Cognitive Impairments, Multimorbidity
Conditions
Keywords
Veterans, Cognitive impairments, Nursing care management, Videoconferencing
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.
Interventions
12-week nurse care management for medically complex Veterans with CI delivered via videoconference
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat | 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 | 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 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression | 14 weeks | Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better) |
| Number of Participants With Hospitalizations or Emergency Department Visits | 14 weeks | Descriptive analysis of emergency department visits and hospitalizations in the two study arms |
| Anxiety | 14 weeks | Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better) |
| Social Support | 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) |
| Physical Activity | 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 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 CI delivered via telephone calls | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Videoconference Care Management | Total | Telephone Care Management |
|---|---|---|---|
| Age, Continuous Caregivers | 60.6 years STANDARD_DEVIATION 12 | 64.7 years STANDARD_DEVIATION 10.8 | 68.9 years STANDARD_DEVIATION 7.7 |
| Age, Continuous Veterans | 70.2 years STANDARD_DEVIATION 3.8 | 72.4 years STANDARD_DEVIATION 6.1 | 74.6 years STANDARD_DEVIATION 7.1 |
| Comfortable with Using the Internet Caregivers | 16 Participants | 27 Participants | 11 Participants |
| Comfortable with Using the Internet Veterans | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Veterans Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Veterans Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Veterans Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Has Accessed Internet with Tablet Computer Caregivers | 12 Participants | 16 Participants | 4 Participants |
| Has Accessed Internet with Tablet Computer Veterans | 4 Participants | 6 Participants | 2 Participants |
| Internet Use in Last Year Caregivers | 19 Participants | 32 Participants | 13 Participants |
| Internet Use in Last Year Veterans | 15 Participants | 28 Participants | 13 Participants |
| Likely to see healthcare provider using videochat Caregivers | 12 Participants | 26 Participants | 14 Participants |
| Likely to see healthcare provider using videochat Veterans | 11 Participants | 19 Participants | 8 Participants |
| Previously Used Videochat Caregivers | 13 Participants | 23 Participants | 10 Participants |
| Previously Used Videochat Veterans | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 8 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers White | 12 Participants | 29 Participants | 17 Participants |
| Race (NIH/OMB) Veterans American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veterans Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veterans Black or African American | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) Veterans More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veterans Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veterans Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veterans White | 12 Participants | 25 Participants | 13 Participants |
| Region of Enrollment United States | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Caregivers Female | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Caregivers Male | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Veterans Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Veterans Male | 20 Participants | 40 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 4 / 20 | 3 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 1 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 14 weeks
Population: These numbers represent the Veterans in the sample (Care Partners not analyzed)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Videoconference Care Management | Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat | 6 Participants |
| Telephone Care Management | Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat | 5 Participants |
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.
Time frame: 14 weeks
Population: These number represent the Veterans in the sample (Care Partners not analyzed)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Videoconference Care Management | Number of Scheduled Intervention Phone or Video Calls Completed by Participants | 46 calls |
| Telephone Care Management | Number of Scheduled Intervention Phone or Video Calls Completed by Participants | 53 calls |
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).
Time frame: 14 weeks
Population: The System Usability Scale was administered only to the videoconference care management Veteran participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoconference Care Management | Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI | 59.3 score on a scale | Standard Deviation 18.6 |
Anxiety
Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
Time frame: 14 weeks
Population: The GAD-7 was administered to the Veteran participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoconference Care Management | Anxiety | 4.2 score on a scale | Standard Deviation 3.5 |
| Telephone Care Management | Anxiety | 4.3 score on a scale | Standard Deviation 3.8 |
Depression
Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
Time frame: 14 weeks
Population: The PHQ-9 was administered to the Veteran participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoconference Care Management | Depression | 6.4 score on a scale | Standard Deviation 5.8 |
| Telephone Care Management | Depression | 4.6 score on a scale | Standard Deviation 3.7 |
Number of Participants With Hospitalizations or Emergency Department Visits
Descriptive analysis of emergency department visits and hospitalizations in the two study arms
Time frame: 14 weeks
Population: Utilization data was collected for Veteran participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Videoconference Care Management | Number of Participants With Hospitalizations or Emergency Department Visits | Hospitalizations | 2 participants |
| Videoconference Care Management | Number of Participants With Hospitalizations or Emergency Department Visits | ED Visits | 4 participants |
| Telephone Care Management | Number of Participants With Hospitalizations or Emergency Department Visits | Hospitalizations | 1 participants |
| Telephone Care Management | Number of Participants With Hospitalizations or Emergency Department Visits | ED Visits | 1 participants |
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)
Time frame: 14 weeks
Population: The PASE was administered to the Veteran participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoconference Care Management | Physical Activity | 75.1 weighted sum | Standard Deviation 65.1 |
| Telephone Care Management | Physical Activity | 108.9 weighted sum | Standard Deviation 73.8 |
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)
Time frame: 14 weeks
Population: The PROMIS subscales were administered to the Veteran participants only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Videoconference Care Management | Quality of Life Outcome | PROMIS-29 (Pain Interference) | 11.5 score on a scale | Standard Deviation 5.7 |
| Videoconference Care Management | Quality of Life Outcome | PROMIS-29 (Physical Function) | 12.3 score on a scale | Standard Deviation 4.2 |
| Videoconference Care Management | Quality of Life Outcome | PROMIS-29 (Social Roles) | 10.8 score on a scale | Standard Deviation 3.8 |
| Telephone Care Management | Quality of Life Outcome | PROMIS-29 (Pain Interference) | 10.9 score on a scale | Standard Deviation 4.8 |
| Telephone Care Management | Quality of Life Outcome | PROMIS-29 (Physical Function) | 11.4 score on a scale | Standard Deviation 5.5 |
| Telephone Care Management | Quality of Life Outcome | PROMIS-29 (Social Roles) | 11.5 score on a scale | Standard Deviation 4.9 |
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)
Time frame: 14 weeks
Population: The mMOS-SS was administered to the Veteran participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoconference Care Management | Social Support | 70.2 score on a scale | Standard Deviation 26 |
| Telephone Care Management | Social Support | 72.7 score on a scale | Standard Deviation 26 |