Clinical trial NCT05560451: Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity
Official title: Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multimorbidity
Keywords: Peer health coaching
Health-related quality of life
Veterans
Multimorbidity
Self-management
Social support
Multiple chronic conditions
Telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-09-29
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid type 1 trial with 294 Veterans with multimorbidity. Participants will be randomized to one of two groups -- the control or intervention group -- in parallel for the duration of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The VetASSIST study is a randomized clinical trial testing whether receiving virtual health coaching from Veteran peers improves the physical and mental health-related quality of life of Veterans with multiple chronic health conditions and complex healthcare needs. VetASSIST will test the efficacy of an intervention that matches Veteran patients with multimorbidty with Veteran health coaches who will provide education, resources, guidance and support to help them manage their physical and mental health over the course of a year.

Detailed description: The study objective is to evaluate the effectiveness of a virtual, Veteran peer-led self-management support program (VetASSIST) to improve health related quality of life (HRQoL) for Veterans with multimorbidity compared to usual care. The investigators will conduct a type 1 hybrid effectiveness-implementation randomized controlled trial of the intervention among VA Puget Sound patients with multimorbidity. Trained peer health coaches will virtually meet one-on-one with patients to assist in daily self-management by providing information; identifying patients' values and preferences; helping them set goals in alignment with their values and preferences and problem-solve barriers to those goals; modeling skills for effective management; providing social support; linking them to clinical care and community resources; and addressing self-management barriers. Veterans with multimorbidity will be randomized to receive the peer health coaching intervention or usual care. Outcomes will be assessed remotely at baseline and 12 months.

Specific aims are: 1) Test the effect of VetASSIST, compared to usual care, on the primary outcome of baseline to 12-month change in physical HRQoL, and secondary outcomes of mental HRQoL and health care utilization; 2a) Describe differences between VetASSIST and usual care on baseline to 12-month changes in intermediate outcomes reflecting the functions of peer support and intervention targets (self-efficacy, patient activation, health behaviors, social support, perceived access to care, patient-provider communication, and shared decision-making); 2b) Examine whether intermediate outcomes mediate intervention-associated differences in HRQoL; 3) Evaluate feasibility of translating VetASSIST into practice, including evaluation of per patient intervention costs and barriers and facilitators to implementation.

Eligibility criteria: Inclusion Criteria:

* Veteran patient receiving primary care from VA Puget Sound
* Complex multimorbidity (\>=3 chronic conditions in \>=3 body systems based on AHRQ Chronic Condition Index)
* Meets \>=2 criterion from NICE multimorbidity guidelines: 1) have a chronic physical and mental health condition (via ICD-10 codes in CDW and the CCI); 2) frailty (determined by the JEN Frailty Index available in VA data, confirmed via self-reported PRISMA-7 during the eligibility screening; 3) frequent emergency care (\>=1 VA emergency department visit in past year via CDW); 4) polypharmacy (\>=10 prescribed medications via CDW), or 5) significant treatment burden (score \>22 on the self-reported Multimorbidity Treatment Burden Questionnaire at study screening).
* Inclusion criteria assessed via the phone screen includes frailty; treatment burden; and willingness to use a either a phone or an Internet-connected device with a web camera and an email address and/or ability to receive text messages to ensure receipt of VVC visit links.
* Agree to participate in the health coaching sessions and surveys if assigned to intervention group

Exclusion Criteria:

* Not fluent in English
* Severe hearing loss
* No phone access and/or missing phone number
* Missing address
* Diagnosis of dementia or severe cognitive impairment within last year
* Diagnosis of end stage renal disease or on dialysis within last year
* Receipt of palliative or hospice care in the past year
* Receipt of nursing home care in past year (Stop codes: 650, 651,119,121)
* Currently living in a nursing home, skilled nursing facility, rehabilitation facility, or long-term care facility
* Behavior flags in EHR
* Active treatment for non-melanoma skin cancer diagnosis
* Diagnosis of substance use dependence/abuse disorder in last year (excluding tobacco)
* Diagnosis of psychotic disorder in last year
* Pregnant or planning to become pregnant in next 6 months
* Score of \>8 (severe risk) on self-reported AUDIT-C questions on eligibility screen

Primary outcomes:
measure: Change in physical health related quality of life (HRQoL)
timeFrame: Baseline to 12-months
Secondary outcomes:
measure: Change in mental health quality of life (HRQoL)
timeFrame: Baseline to 12-months
measure: Health care utilization
timeFrame: Baseline to 12-months
Other outcomes:
measure: Self-efficacy
timeFrame: Baseline to 12-months
measure: Patient activation
timeFrame: Baseline to 12-months
measure: Social support
timeFrame: Baseline to 12-months
measure: Loneliness
timeFrame: Baseline to 12-months
measure: Access to care
timeFrame: Baseline to 12-months
measure: Patient-provider communication
timeFrame: Baseline to 12-months
measure: Shared decision-making
timeFrame: Baseline to 12-months
measure: Diet quality
timeFrame: Baseline to 12-months
measure: Medication adherence
timeFrame: Baseline to 12-months
measure: Tobacco use
timeFrame: Baseline to 12-months
measure: Alcohol use
timeFrame: Baseline to 12-months
measure: Sleep impairment/disturbance
timeFrame: Baseline to 12-months
measure: Physical activity
timeFrame: Baseline to 12-months
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Kristen E. Gray, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Katherine D Hoerster, PhD MPH BA
role: PRINCIPAL_INVESTIGATOR
References: