Clinical trial NCT04922320: Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Official title: Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Chronic Conditions
Decision Making, Shared
Keywords: Patient Centered Care
Geriatrics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-06-10
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All consented participants who complete baseline assessment will be randomized into the PPC or UC groups. Randomization will be blocked and stratified by PCP to assure balance in the number of patients assigned to two study arms by enrolled PCP. Within each clinician, the investigators will use random blocks of 4 and 6. Blocking ensures half will be randomized to PPC and half to UC. Varying block size makes the sequence of assignments more difficult to predict. The random numbers will be generated in SAS PROC PLAN. The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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?"

Primary outcomes:
measure: Patient Reported Treatment Burden
timeFrame: 4 month follow-up
measure: Home and Community Services Use
timeFrame: 4 month follow-up
Secondary outcomes:
measure: shared decision making
timeFrame: 4 month follow-up
measure: Patients' goal setting
timeFrame: 4 month follow-up
measure: Ambulatory Care Utilization
timeFrame: 4 month follow-up
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Lilian N. Dindo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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