Decision Making, Shared, Multiple Chronic Conditions
Conditions
Keywords
Patient Centered Care, Geriatrics
Brief summary
The investigators will conduct a randomized control trial enrolling 420 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.
Interventions
BEHAVIORALPatient Priorities Care
A facilitator will schedule a PPC facilitation encounter 2-3 weeks before an upcoming PCP visit. The facilitator conducts a structured assessment using a written conversation guide that begins with general questions establishing what is most important to Veterans about their health and moves toward establishing specific goals (actionable outcomes), and what patients are willing/not willing to do to achieve these goals (care preferences). The result is a structured patient priorities report delivered to PCPs designed to facilitate changes in the patient's care plan to align it with his/her priorities. In the subsequent visit, the PCP will use one or more of the established PPC decisional strategies to align care with patients' priorities. Education for PCPs about the facilitation process, the patient priorities report, and the decisional strategies occurs prior to the PCP seeing any intervention patients. The PCP will document changes in care made to achieve the identified priorities.
OTHERUsual Care
PCPs will not be alerted when an encounter involves a UC group participant. UC participant visits will appear the same as all other unenrolled patient encounters. PCPs will be trained to address the needs of UC participants based on their typical approach without the use of a facilitator or explicit process for identifying patient priorities. UC participants will not receive any additional preparation
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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?"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants Reporting 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. For Home and community based services delivered by the VA, GEC-DAC has created a composite measure. Due to Department of Veterans Affairs policy changes after 2018, a significant proportion of VA home and community services and supports were delivered and paid by the Community Care Reimbursement System. As a result the Integrated Veteran Care Consolidation Data Sets (IVC-CDS) become a primary source for VA community care data. For the current study, we drew from both data sources: GEC-DAC and IVC-CDS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making | 4 month follow-up | Measured using the CollaboRATE scale (3 items; possible range for each item 0-9; total range 0-27; 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 (10 items; range, 1-5; total range 10-50; Cronbach = 0.87; higher scores indicate better perceived chronic disease care). |
| Ambulatory Care Utilization - Change in Care | 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 document if specific changes in care (i.e., medications, referrals, testing, self-management) are made. |
| Ambulatory Care Utilization - Type of Change | 4 month follow-up | Medications added or stopped and tests, referrals, and self-management tasks ordered or avoided. Measured using a structured chart review tool using our validated process to guide uniform abstraction and classification to identify changes based on adding, discontinuing, or avoiding treatment actions across all care types (i.e. medication, testing, referrals, self-management). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLilian N. Dindo, PhD
Michael E. DeBakey VA Medical Center, Houston, TX
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 75.19 Age STANDARD_DEVIATION 6.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 308 Participants |
| Sex/Gender, Customized Female | 11 Participants |
| Sex/Gender, Customized Male | 196 Participants |
| Sex/Gender, Customized Refused to Answer | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 209 | 4 / 208 |
| other Total, other adverse events | 0 / 209 | 0 / 208 |
| serious Total, serious adverse events | 41 / 209 | 40 / 208 |
Outcome results
None listed