Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions

Not Applicable

Completed

• Conditions: Multiple Chronic Conditions; Decision Making, Shared

• Registration Number: NCT04922320
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Study Start: 2022-09-15
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• 2 encounters in prior 18 months
• 3 active health problems on active problem list or prescribed 10 medications

Exclusion Criteria

• nursing home resident

• end stage renal disease on dialysis

• active serious mental illness (psychosis, schizophrenia, etc)

• active substance use disorder

• complete hearing loss

• dementia

• Non-English speaker (translator required)

• 4 or more no-show appointments in the last 6 months

• the investigators will present a list of eligible patients to PCPs prior to chart review to identify patients who the PCP:

  • a) believes cannot participate independently or provide informed consent due to cognitive impairment
  • b) "would not be surprised if the patient passed away within the next 12 months?"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Reported Treatment Burden	4 month follow-up	Measured by the validated Treatment Burden Questionnaire, treatment burden measures perceptions of burdensomeness of overall care and treatment burden (e.g., medication taking, self-monitoring, visits to the provider, tests, tasks to access and coordinate care) imposed by healthcare as assessed with 15 items; possible range, 0-150; Cronbach = 0.90; higher scores indicate greater perceived burden.
Home and Community Services Use	4 month follow-up	Home and community based services includes care that supports independence and the ability to stay in one's own home. They are defined by the VA Geriatrics and Extended Care Data Analysis Center (GEC-DAC) as VA Long Term Services and Supports: adult day health care, home based primary care, homemaker and home health aide, hospice care, palliative care, respite care, skilled home health care, home telehealth, and home care services. GEC-DAC has created a composite measure, which is associated with delays in nursing home and institutional long-term care placement.

Secondary Outcome Measures

Name	Time	Method
shared decision making	4 month follow-up	Measured using the CollaboRATE scale (3 items; possible range 0-100; Cronbach = 0.89; higher score indicates greater perceived shared decision-making and goal ascertainment).
Patients' goal setting	4 month follow-up	Will measure patients' perceptions of whether health care decisions were collaborative and focused on their goals using the Older Patient Assessment of Chronic Illness Care (OPACIC) score (11 items; range, 1-5; Cronbach = 0.87; higher scores indicate better perceived chronic disease care).
Ambulatory Care Utilization	4 month follow-up	Medications added or stopped and diagnostic tests, referrals, and procedures ordered or avoided. Measured using a structured chart review tool using our validated process to guide uniform abstraction and classification to a) document specific changes in treatment (i.e., medications, referrals, diagnostics, self-care, services and supports), b) attribute changes to alignment with priorities, and c) identify documentation of any avoided care.

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States