An interventional study of Patient Priorities Care and Usual Care in Multiple Chronic Conditions and Decision Making, Shared, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 437 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
the investigators will present a list of eligible patients to PCPs prior to chart review to identify patients who the PCP:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Patient Priorities 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. UC participants will not receive any additional preparation
Other: Usual Care
Enrolled PCPs will receive brief training on strategies to align care with priorities. PCPs will receive an electronic alert to review the health priorities note written by the facilitators before the participant's upcoming (within 1-2 weeks) clinic visit. PCPs will use the health priorities note to guide communication and decision making with their patients regarding their care recommendations. Eligible patients of the enrolled PCPs will be randomized into either the PPC or UC study arms
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.
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
Patient Reported Treatment Burden
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.
Time frame: 4 month follow-up
Number of Participants Reporting Home and Community Services Use
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.
Time frame: 4 month follow-up
Shared Decision Making
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).
Time frame: 4 month follow-up
Patients' Goal Setting
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).
Time frame: 4 month follow-up
Ambulatory Care Utilization - Change in Care
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.
Time frame: 4 month follow-up
Ambulatory Care Utilization - Type of Change
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).
Time frame: 4 month follow-up
| Milestone | Primary Care Providers | Patient Priorities Care | Usual Care |
|---|---|---|---|
| Started | 17 | 210 | 210 |
| Primary care providers enrolled (not randomized) | 17 | 0 | 0 |
| Intent to treat | 17 | 209 | 208 |
| Treatment as received | 17 | 167 | 191 |
| Follow-up | 17 | 190 | 191 |
| Completed | 17 | 190 | 191 |
| Not completed | 0 | 20 | 19 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 |
| Withdrew: Lost to follow-up | 0 | 15 | 15 |
| Withdrew: Death | 0 | 4 | 2 |
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.
| Treatment Burden Score on a Scale | Patient Priorities Care | Usual Care |
|---|---|---|
| Patient Reported Treatment Burden | 15.71 ± 17.36 | 19.51 ± 26.47 |
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.
| Participants | Patient Priorities Care | Usual Care |
|---|---|---|
| Number of Participants Reporting Home and Community Services Use | 20 | 13 |
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).
| Score on a Scale | Patient Priorities Care | Usual Care |
|---|---|---|
| Shared Decision Making | 24.99 ± 4.12 | 24.72 ± 4.93 |
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).
| Score on a Scale | Patient Priorities Care | Usual Care |
|---|---|---|
| Patients' Goal Setting | 35.80 ± 11.17 | 35.44 ± 10.29 |
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.
| Changes | Patient Priorities Care | Usual Care |
|---|---|---|
| Medication | 334 | 335 |
| Referral | 237 | 201 |
| Self-Management | 302 | 278 |
| Testing | 212 | 223 |
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).
| Changes | Patient Priorities Care | Usual Care |
|---|---|---|
| Added | 858 | 810 |
| Discontinued | 68 | 69 |
| Avoided | 159 | 158 |
Collected over Tracking of adverse events for each enrolled participant began after the date of their primary care provider visit and extended for the subsequent 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Priorities Care | 5/209 (2.4%) | 41/209 (19.6%) | 0/209 (0%) |
| Usual Care | 4/208 (1.9%) | 40/208 (19.2%) | 0/208 (0%) |
| Event | Patient Priorities Care | Usual Care |
|---|---|---|
| Emergency Department or Urgent Care VisitsGeneral disorders | 26/209 | 24/208 |
| Hospital Admissions or Observation StaysGeneral disorders | 15/209 | 16/208 |
Baseline demographics were not collected for Primary Care Providers.
| Age, Continuous(Age) | Patient Priorities Care | Usual Care | Total |
|---|---|---|---|
| Mean | 75.40 ± 6.26 | 74.92 ± 6.42 | 75.19 ± 6.34 |
| Sex/Gender, Customized(Participants) | Patient Priorities Care | Usual Care | Total |
|---|---|---|---|
| Male | 202 | 196 | 398 |
| Female | 7 | 11 | 18 |
| Refused to Answer | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Patient Priorities Care | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 41 | 40 | 81 |
| White | 153 | 155 | 308 |
| More than one race | 6 | 5 | 11 |
| Unknown or Not Reported | 6 | 7 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Patient Priorities Care | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 22 | 15 | 37 |
| Not Hispanic or Latino | 183 | 187 | 370 |
| Unknown or Not Reported | 4 | 6 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2022 to primary completion in Apr 2025, 31 months.
Results were first posted in Sep 2026, 1 year 4 months after primary completion.
Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 31 months is above that.
Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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