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

Overview

The investigators will conduct a randomized control trial enrolling 366 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.

Full Title of Study: “Effectiveness of Patient Priorities Care for Older Adults With Multiple Chronic Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 28, 2024

Interventions

  • Behavioral: 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.
  • Other: 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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Patient Reported Treatment Burden
    • Time Frame: 6 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.
  • Home and Community Services Use
    • Time Frame: 6 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 Measures

  • shared decision making
    • Time Frame: 6 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).
  • Patients’ goal setting
    • Time Frame: 6 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).
  • Ambulatory care utilization
    • Time Frame: 6 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.
  • Patient-clinician conversation analysis for changes in care that are aligned with identified priorities
    • Time Frame: 6 month follow-up
    • The investigators will collect audio recordings of 2 patient encounters from each study arm for a random subset of 10 providers (5 per site, for a total of 40 recordings). Using discourse analytic techniques validated in past studies, the investigators will code transcripts to determine whether: (a) patient values and outcome goals were identified, (b) care preferences were discussed, and (c) care recommendations were aligned with priorities (i.e., discussion explicitly aligning care recommendations with priorities, care recommendations were congruent with priorities, or care was not aligned with priorities).

Participating in This Clinical Trial

Inclusion Criteria

  • 2 encounters in prior 12 months – 3 active health problems on active problem list or prescribed 10 medications Exclusion Criteria:

  • nursing home resident – end stage renal disease on dialysis – PCP endorsement of a validated palliative care screening question – the investigators will present a list of eligible patients to PCPs prior to telephone contact 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?"

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aanand Dinkar Naik, MD BA, Principal Investigator, Michael E. DeBakey VA Medical Center, Houston, TX
  • Overall Contact(s)
    • Aanand D Naik, MD BA, (713) 794-8541, Aanand.Naik@va.gov

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