AzTrials
AzTrials

Multiple Chronic ConditionsPPCNCT04922320

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

A study testing Patient Priorities Care in people with Multiple Chronic Conditions and Decision Making, Shared, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Patient Priorities Care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
437 participants
Where
2 sitesUnited States
Study dates
15 Sep 2022to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • nursing home resident
  • end stage renal disease on dialysis
  • active serious mental illness (psychosis, schizophrenia, etc)
  • active substance use disorder
  • complete hearing loss
  • dementia
Show all 11Show fewer
  • 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?"

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

Other trials in United States

About this study

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.

Being tested
Patient Priorities Care, Usual Care
Keywords
Patient Centered Care, Geriatrics
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Priorities CareBehavioural

    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.

  • Usual CareOther

    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

Study groups in NCT04922320
Study groupRoleWhat they receive
Patient Priorities CareExperimentalA 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.
Receives: Behavioral: Patient Priorities Care
Usual CarePlacebo comparatorPCPs 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
Receives: Other: Usual Care
Primary Care ProvidersNo interventionEnrolled 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 month follow-up

  2. 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.

    Measured: 4 month follow-up

Secondary outcomes (4)
  1. 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).

    Measured: 4 month follow-up

  2. 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).

    Measured: 4 month follow-up

  3. 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.

    Measured: 4 month follow-up

  4. 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).

    Measured: 4 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start15 Sep 2022
  3. Primary completion30 Apr 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922320
Sponsor's protocol ID
IIR 20-079
Other IDs
1 I01 HX003211-01A1, CIN 13-413
Acronym
PPC
Status last verified
Aug 2026
First submitted
4 Jun 2021
Last updated
14 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cohen AB, Paiva AL, Redding CA, Fried TR. Characteristics of Older Adults Who Cannot Identify a Healthcare Agent. J Gen Intern Med. 2022 Apr;37(5):1313-1314. doi: 10.1007/s11606-021-06798-2. Epub 2021 Apr 26. No abstract available.

    PubMed 33904034
  • Ouellet GM, Fried TR, Gilstrap LG, O'Leary JR, Austin AM, Skinner JS, Cohen AB. Anticoagulant Use for Atrial Fibrillation Among Persons With Advanced Dementia at the End of Life. JAMA Intern Med. 2021 Aug 1;181(8):1121-1123. doi: 10.1001/jamainternmed.2021.1819.

    PubMed 33970197
  • Naik AD, Shanahan ML, Dindo L, Mecca MC, Arney J, Amspoker AB, Wydermyer S, Banks J, Street RL Jr, Kiefer L, Zenoni M, Rosen T, Gonzalez RD, Catic A, Fried TR. An innovative approach to aligning healthcare with what matters most to patients: A hybrid type 1 trial protocol of patient priorities care for older adults with multiple chronic conditions. Contemp Clin Trials. 2024 Aug;143:107613. doi: 10.1016/j.cct.2024.107613. Epub 2024 Jun 22.

    PubMed 38914308
  • Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.

    PubMed 35132555
  • Naik AD, Walling AM. Getting patients ready for "in the moment" decisions. J Am Geriatr Soc. 2022 Sep;70(9):2474-2477. doi: 10.1111/jgs.17935. Epub 2022 Jul 4. No abstract available.

    PubMed 35781226
  • Lee YK, Fried TR, Costello DM, Hajduk AM, O'Leary JR, Cohen AB. Perceived dementia risk and advance care planning among older adults. J Am Geriatr Soc. 2022 May;70(5):1481-1486. doi: 10.1111/jgs.17721. Epub 2022 Mar 11.

    PubMed 35274737
  • Zang E, Shi Y, Wang X, Wu B, Fried TR. Trajectories of physical functioning among US adults with cognitive impairment. Age Ageing. 2022 Jun 1;51(6):afac139. doi: 10.1093/ageing/afac139.

    PubMed 35751871
  • Fried TR. Giving up on the objective of providing goal-concordant care: Advance care planning for improving caregiver outcomes. J Am Geriatr Soc. 2022 Oct;70(10):3006-3011. doi: 10.1111/jgs.18000. Epub 2022 Aug 16.

    PubMed 35974460
  • Amenta E, Grigoryan L, Rajan SS, Ramsey D, Kramer JR, Walder A, Chou A, Van JN, Krein SL, Hysong S, Naik AD, Trautner BW. Quantifying the Implementation and Cost of a Multisite Antibiotic Stewardship Intervention for Asymptomatic Bacteriuria. Antimicrob Steward Healthc Epidemiol. 2023 Jun 30;3(1):e115. doi: 10.1017/ash.2023.198. eCollection 2023.

    PubMed 37502251
  • Dindo L, Chaison A, Rodrigues M, Woods K, Mark A, Boykin D. Feasibility of delivering a virtual 1-day acceptance and commitment therapy workshop to rural veterans through community partnerships. Contemp Clin Trials Commun. 2023 Jun 20;34:101178. doi: 10.1016/j.conctc.2023.101178. eCollection 2023 Aug.

    PubMed 37409189
  • Chary AN, Brickhouse E, Torres B, Santangelo I, Carpenter CR, Liu SW, Godwin KM, Naik AD, Singh H, Kennedy M. Leveraging the Electronic Health Record to Implement Emergency Department Delirium Screening. Appl Clin Inform. 2023 May;14(3):478-486. doi: 10.1055/a-2073-3736. Epub 2023 Apr 13.

    PubMed 37054983
  • Chary A, Brickhouse E, Torres B, Cameron-Comasco L, Lee S, Punches B, Skains RM, Naik AD, Quatman-Yates CC, Kennedy M, Southerland LT, Liu S. Physical therapy consultation in the emergency department for older adults with falls: A qualitative study. J Am Coll Emerg Physicians Open. 2023 Apr 19;4(2):e12941. doi: 10.1002/emp2.12941. eCollection 2023 Apr.

    PubMed 37090953
  • Chary A, Hernandez N, Rivera AP, Ramont V, Obi T, Santangelo I, Ritchie C, Singh H, Hayden E, Naik AD, Liu S, Kennedy M. Perceptions of Acute Care Telemedicine Among Caregivers for Persons Living with Dementia: A Qualitative Study. J Appl Gerontol. 2024 Jan;43(1):69-77. doi: 10.1177/07334648231198018. Epub 2023 Sep 8.

    PubMed 37682526
  • Freytag J, Mishra RK, Street RL Jr, Catic A, Dindo L, Kiefer L, Najafi B, Naik AD. Using Wearable Sensors to Measure Goal Achievement in Older Veterans with Dementia. Sensors (Basel). 2022 Dec 16;22(24):9923. doi: 10.3390/s22249923.

    PubMed 36560290
  • Razjouyan J, Horstman MJ, Orkaby AR, Virani SS, Intrator O, Goyal P, Amos CI, Naik AD. Developing a Parsimonious Frailty Index for Older, Multimorbid Adults With Heart Failure Using Machine Learning. Am J Cardiol. 2023 Mar 1;190:75-81. doi: 10.1016/j.amjcard.2022.11.044. Epub 2022 Dec 23.

    PubMed 36566620

Questions about this trial

What is this clinical trial studying?

A study testing Patient Priorities Care in people with Multiple Chronic Conditions and Decision Making, Shared, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Reported Treatment Burden (time frame: 4 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922320, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in