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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT04922320
Collaborator
(none)
366
2
2
33.5
183
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Priorities Care
  • Other: Usual Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Outcomes Assessor)
Masking Description:
The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.
Primary Purpose:
Health Services Research
Official Title:
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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

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

Outcome Measures

Primary Outcome Measures

  1. Patient Reported Treatment Burden [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.

  2. Home and Community Services Use [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 Outcome Measures

  1. shared decision making [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).

  2. Patients' goal setting [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).

  3. Ambulatory care utilization [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.

  4. Patient-clinician conversation analysis for changes in care that are aligned with identified priorities [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

    1. believes cannot participate independently or provide informed consent due to cognitive impairment
    1. "would not be surprised if the patient passed away within the next 12 months?"

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut United States 06516
2 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Aanand Dinkar Naik, MD BA, Michael E. DeBakey VA Medical Center, Houston, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04922320
Other Study ID Numbers:
  • IIR 20-079
  • 1 I01 HX003211-01A1
  • CIN 13-413
First Posted:
Jun 10, 2021
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2022