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

NCT ID: NCT04922320

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Chronic Conditions Decision Making, Shared

Keywords

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Patient Centered Care Geriatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.

Study Groups

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Patient 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.

Group Type EXPERIMENTAL

Patient Priorities Care

Intervention Type BEHAVIORAL

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 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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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Patient 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.

Intervention Type BEHAVIORAL

Usual 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

Intervention Type OTHER

Eligibility Criteria

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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?"
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilian N. Dindo, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Locations

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

West Haven, Connecticut, United States

Site Status

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status

Countries

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United States

References

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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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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.

Reference Type RESULT
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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.

Reference Type RESULT
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Reference Type RESULT
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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.

Reference Type RESULT
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Reference Type RESULT
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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.

Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1 I01 HX003211-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIN 13-413

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 20-079

Identifier Type: -

Identifier Source: org_study_id