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OpenTrials
Completed

NCT Number: NCT04922320

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

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.

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Key information

Conditions

Multiple Chronic Conditions Chronic Disease Decision Making, Shared Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?"

Treatment and study plan

Patient Priorities Care

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

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

Primary outcomes

  1. Patient Reported Treatment Burden

    Time frame: 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.

  2. Home and Community Services Use

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

Secondary outcomes

  1. shared decision making

    Time frame: 4 month follow-up

    Measured using the CollaboRATE scale (3 items; possible range 0-100; Cronbach = 0.89; higher score indicates greater perceived shared decision-making and goal ascertainment).

  2. Patients' goal setting

    Time frame: 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 (11 items; range, 1-5; Cronbach = 0.87; higher scores indicate better perceived chronic disease care).

  3. Ambulatory Care Utilization

    Time frame: 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 a) document specific changes in treatment (i.e., medications, referrals, diagnostics, self-care, services and supports), b) attribute changes to alignment with priorities, and c) identify documentation of any avoided care.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: PPC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2021
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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