NCT04922320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

June 4, 2021

Last Update Submit

December 22, 2025

Conditions

Multiple Chronic ConditionsDecision Making, Shared

Keywords

Patient Centered CareGeriatrics

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 month follow-up

  • 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. GEC-DAC has created a composite measure, which is associated with delays in nursing home and institutional long-term care placement.

    4 month follow-up

Secondary Outcomes (3)

  • shared decision making

    4 month follow-up

  • Patients' goal setting

    4 month follow-up

  • Ambulatory Care Utilization

    4 month follow-up

Study Arms (2)

Patient Priorities Care

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

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

Interventions

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

Usual Care
Patient Priorities CareBEHAVIORAL

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.

Patient Priorities Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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?"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

West Haven, Connecticut, 06516-2770, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (20)

  • 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.

    PMID: 33904034BACKGROUND

  • 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.

    PMID: 33970197BACKGROUND

  • 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.

    PMID: 35132555RESULT

  • 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.

    PMID: 35781226RESULT

  • 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.

    PMID: 35274737RESULT

  • 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.

    PMID: 35751871RESULT

  • 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.

    PMID: 35974460RESULT

  • 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.

    PMID: 37502251RESULT

  • 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.

    PMID: 37409189RESULT

  • 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.

    PMID: 37054983RESULT

  • 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.

    PMID: 37090953RESULT

  • 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.

    PMID: 37682526RESULT

  • 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.

    PMID: 36560290RESULT

  • 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.

    PMID: 36566620RESULT

  • Crespo-Ramos G, Bebu I, Krause-Steinrauf H, Hoogendoorn CJ, Fang R, Ehrmann D, Presley C, Naik AD, Katona A, Walker EA, Cherrington A, Gonzalez JS; GRADE Research Group. Emotional distress and cardiovascular disease risk among participants enrolled in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study. Diabetes Res Clin Pract. 2023 Sep;203:110808. doi: 10.1016/j.diabres.2023.110808. Epub 2023 Jun 30.

    PMID: 37394014RESULT

  • Ritchey KC, Solberg LM, Citty SW, Kiefer L, Martinez E, Gray C, Naik AD. Guiding Post-Hospital Recovery by 'What Matters:' Implementation of Patient Priorities Identification in a VA Community Living Center. Geriatrics (Basel). 2023 Jul 4;8(4):74. doi: 10.3390/geriatrics8040074.

    PMID: 37489322RESULT

  • Chary AN, Torres B, Brickhouse E, Santangelo I, Godwin KM, Naik AD, Carpenter CR, Liu SW, Kennedy M. Language discordance in emergency department delirium screening: Results from a qualitative interview-based study. J Am Geriatr Soc. 2023 Apr;71(4):1328-1331. doi: 10.1111/jgs.18147. Epub 2022 Nov 30. No abstract available.

    PMID: 36451059RESULT

  • Chary AN, Naik AD, Kennedy M. Reply to: Expanding options to include language barriers for predicting postoperative delirium in geriatric patients. J Am Geriatr Soc. 2023 Jan;71(1):294-295. doi: 10.1111/jgs.18083. Epub 2022 Oct 17. No abstract available.

    PMID: 36254368RESULT

  • Naik AD. Measuring patient-centered care to improve hospital experiences of older adults. J Am Geriatr Soc. 2022 Dec;70(12):3348-3351. doi: 10.1111/jgs.18048. Epub 2022 Sep 20. No abstract available.

    PMID: 36125214RESULT

  • Scholle SH, Naik AD. A Person-Centered Care Dashboard for Individuals With Complex Health Care Needs-Charting a Course for the Future. JAMA Netw Open. 2022 Aug 1;5(8):e2224945. doi: 10.1001/jamanetworkopen.2022.24945. No abstract available.

    PMID: 35917127RESULT

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lilian N. Dindo, PhD

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

September 15, 2022

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)