Back to resultsEffect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Primary Purpose
Multiple Chronic Conditions, Decision Making, Shared
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Priorities Care
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Chronic Conditions focused on measuring Patient Centered Care, Geriatrics
Eligibility Criteria
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?"
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting
- Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patient Priorities Care
Usual Care
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
shared decision making
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
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
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.
Full Information
NCT ID
NCT04922320
First Posted
June 4, 2021
Last Updated
August 22, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04922320
Brief Title
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Official Title
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions, Decision Making, Shared
Keywords
Patient Centered Care, Geriatrics
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The research assistant (RA) conducting baseline evaluations will not access any randomization procedures, leaving that RA blinded during the evaluation.
Allocation
Randomized
Enrollment
366 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Priorities Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patient Priorities Care
Intervention Description
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
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Patient Reported Treatment Burden
Description
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.
Time Frame
4 month follow-up
Title
Home and Community Services Use
Description
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.
Time Frame
4 month follow-up
Secondary Outcome Measure Information:
Title
shared decision making
Description
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).
Time Frame
4 month follow-up
Title
Patients' goal setting
Description
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).
Time Frame
4 month follow-up
Title
Ambulatory Care Utilization
Description
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.
Time Frame
4 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aanand D Naik, MD BA
Phone
(713) 794-8541
Email
Aanand.Naik@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Lilian N Dindo, PhD
Phone
(713) 440-4637
Email
lilian.dindo@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian N. Dindo, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Mecca
Phone
203-763-9829
Email
Marcia.Mecca@yale.edu
First Name & Middle Initial & Last Name & Degree
Terri R Fried, MD
Phone
(203) 932-5711
Ext
5412
Email
terri.fried@yale.edu
First Name & Middle Initial & Last Name & Degree
Terri R. Fried, MD
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Rosen, MSPH BA
Phone
(713) 794-8541
Ext
10280
Email
tracey.rosen2@va.gov
First Name & Middle Initial & Last Name & Degree
Lea Kiefer, MPH BA
Phone
(713) 440-4481
Email
lea.kiefer@va.gov
First Name & Middle Initial & Last Name & Degree
Aanand Dinkar Naik, MD BA
First Name & Middle Initial & Last Name & Degree
Lilian N. Dindo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33904034
Citation
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.
Results Reference
background
PubMed Identifier
33970197
Citation
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.
Results Reference
background
PubMed Identifier
35274737
Citation
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.
Results Reference
result
PubMed Identifier
35751871
Citation
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.
Results Reference
result
PubMed Identifier
35974460
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
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