Multiple Chronic Conditions Clinical Trial
Official title:
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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?" |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Amenta E, Grigoryan L, Rajan SS, Ramsey D, Kramer JR, Walder A, Chou A, Van JN, Krein SL, Hysong S, Naik AD, Trautner BW. Quantifying the Implementation and Cost of a Multisite Antibiotic Stewardship Intervention for Asymptomatic Bacteriuria. Antimicrob S — View Citation
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 — View Citation
Chary A, Hernandez N, Rivera AP, Ramont V, Obi T, Santangelo I, Ritchie C, Singh H, Hayden E, Naik AD, Liu S, Kennedy M. Perceptions of Acute Care Telemedicine Among Caregivers for Persons Living with Dementia: A Qualitative Study. J Appl Gerontol. 2024 J — View Citation
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: 10.1 — View Citation
Chary AN, Naik AD, Kennedy M. Reply to: Expanding options to include language barriers for predicting postoperative delirium in geriatric patients. J Am Geriatr Soc. 2023 Jan;71(1):294-295. doi: 10.1111/jgs.18083. Epub 2022 Oct 17. No abstract available. — View Citation
Chary AN, Torres B, Brickhouse E, Santangelo I, Godwin KM, Naik AD, Carpenter CR, Liu SW, Kennedy M. Language discordance in emergency department delirium screening: Results from a qualitative interview-based study. J Am Geriatr Soc. 2023 Apr;71(4):1328-1 — View 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. — View Citation
Crespo-Ramos G, Bebu I, Krause-Steinrauf H, Hoogendoorn CJ, Fang R, Ehrmann D, Presley C, Naik AD, Katona A, Walker EA, Cherrington A, Gonzalez JS; GRADE Research Group. Emotional distress and cardiovascular disease risk among participants enrolled in the — View Citation
Dindo L, Chaison A, Rodrigues M, Woods K, Mark A, Boykin D. Feasibility of delivering a virtual 1-day acceptance and commitment therapy workshop to rural veterans through community partnerships. Contemp Clin Trials Commun. 2023 Jun 20;34:101178. doi: 10.1 — View Citation
Freytag J, Mishra RK, Street RL Jr, Catic A, Dindo L, Kiefer L, Najafi B, Naik AD. Using Wearable Sensors to Measure Goal Achievement in Older Veterans with Dementia. Sensors (Basel). 2022 Dec 16;22(24):9923. doi: 10.3390/s22249923. — View 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. — View 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. — View Citation
Naik AD, Walling AM. Getting patients ready for "in the moment" decisions. J Am Geriatr Soc. 2022 Sep;70(9):2474-2477. doi: 10.1111/jgs.17935. Epub 2022 Jul 4. No abstract available. — View Citation
Naik AD. Measuring patient-centered care to improve hospital experiences of older adults. J Am Geriatr Soc. 2022 Dec;70(12):3348-3351. doi: 10.1111/jgs.18048. Epub 2022 Sep 20. No abstract available. — View 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. — View Citation
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.amjc — View Citation
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 — View Citation
Scholle SH, Naik AD. A Person-Centered Care Dashboard for Individuals With Complex Health Care Needs-Charting a Course for the Future. JAMA Netw Open. 2022 Aug 1;5(8):e2224945. doi: 10.1001/jamanetworkopen.2022.24945. No abstract available. — View Citation
Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2 — View 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. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 month follow-up | |
Primary | 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. | 4 month follow-up | |
Secondary | 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). | 4 month follow-up | |
Secondary | 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). | 4 month follow-up | |
Secondary | 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. | 4 month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05345041 -
Church-based Intervention to Improve Physical Function in African Americans
|
N/A | |
Completed |
NCT03537053 -
An Approach to "Move a Little & Often" With Health Conditions
|
N/A | |
Recruiting |
NCT03885401 -
Enhanced Care Planning for Patients With Multiple Chronic Conditions
|
N/A | |
Completed |
NCT04056663 -
Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
|
N/A | |
Active, not recruiting |
NCT03474692 -
Virta Health Registry
|
||
Completed |
NCT04566107 -
Self-Management Interventions Using Mobile Health for the Multimorbid
|
N/A | |
Completed |
NCT04568382 -
Diabetes Communication and Treatment Burden
|
N/A | |
Recruiting |
NCT05708768 -
Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma
|
||
Recruiting |
NCT05778630 -
Emotions and Cognitions in Pediatric Chronic Physical Conditions
|
N/A | |
Completed |
NCT03600389 -
Patient Priorities Care (PPC)
|
N/A | |
Recruiting |
NCT05877846 -
Precision Medicine and Physical Function
|
N/A | |
Recruiting |
NCT05600465 -
Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
|
N/A | |
Active, not recruiting |
NCT05303194 -
Patient Priorities Care for Hispanics With Dementia
|
N/A | |
Completed |
NCT05156073 -
Shared Decision Making About Medication Use for People With Multiple Health Problems
|
N/A | |
Recruiting |
NCT04188470 -
Optimising Drug Therapy in Polymedicated Patients According to the Person-centered Care Model
|
N/A | |
Terminated |
NCT04595851 -
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
|
N/A | |
Recruiting |
NCT06044571 -
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
|
N/A | |
Completed |
NCT03745703 -
MOCHA Moving Forward: a CBPR Investigation of Chronic Disease Prevention in Older, Low-income African-American Men
|
N/A | |
Recruiting |
NCT05913206 -
Understanding Factors in Decision Making for Children With Medical Complexity
|
N/A | |
Completed |
NCT04492527 -
Student-delivered Telehealth Program for COVID-19 Education and Health Promotion
|
N/A |