Patient Priority Care for Older Adults With Multiple Chronic Conditions
NCT ID: NCT04510948
Last Updated: 2025-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
264 participants
INTERVENTIONAL
2020-08-14
2023-07-30
Brief Summary
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Detailed Description
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We will employ a quasi-experimental, usual care (UC) group design, involving 2 primary care sites (1 PPC and 1 UC. Patients are assigned to intervention or usual care arms based on their primary care practice location. We will use analytic techniques (e.g., inverse propensity score weighting) designed to reduce selection bias and balance PPC and UC sites in terms of baseline characteristics. Data collection will occur through quantitative and qualitative interviews and health encounter information in the Electric Health Record(EHR).
Patient Priorities Care requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with goals and priorities to achieve patients' health outcome goals and reduce the burden of multi-morbidity. Participants will be enrolled in the Patient Priorities Care Program and speak with a trained health priorities facilitator to elicit their healthcare preferences and health outcome goals, which together constitute their health priorities. This information will be documented, entered into the EHR, and shared with the clinicians who will then use the Patient Priorities Care approach with patients to inform and guide treatment decisions. Patients will participate in the program and be followed for up to one year from the health priorities identification visit.
To determine the value of PPC, comparable primary care sites within the Cleveland Clinic will be assigned to PPC or Usual care (UC). Clinicians and staff at the PPC site will be trained to identify and align decision-making with the health priorities of older adults with MCCs. Value will be compared using patient and provider-reported outcomes, healthcare utilization, and possibly costs at PPC and UC sites.
The ultimate goal of our work is to implement and evaluate this approach to care for older adults with multiple chronic conditions that focuses on what matters most to them and is less fragmented and burdensome, resulting in better quality and outcomes at lower cost. This study will focus on evaluating practice change at test sites at the Cleveland Clinic.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention (Implementing Patient Priorities Care)
Patient Priorities Care requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences (collectively referred to as health priorities). Participants will be contacted by a trained priorities facilitator in-person or over the phone to elicit their health priorities. This information will be documented in the PPC- GOALS AND PREFERENCES form in the EHR and shared with the clinicians who will then use the Patient Priorities Care approach with patients to inform and guide treatment decisions.
Patient Priorities Care
Patient Priorities Care (PPC) is an innovative approach to shared decision-making that draws from existing professional training.
PPC requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences. This information will be collected and documented in the EHR by facilitators and shared with the clinicians who will then use the PPC approach with patients to inform and guide treatment decisions.
The PCPs will be trained in decisional strategies that have been shown to help align care with patients' health priorities. While encouraged to use these decisional strategies, PCPs will be free to make the recommendations they feel most appropriate for each patient.
This intervention has been developed to be integrated seamlessly into usual care.
Usual Care (Not implementing PPC)
Patients will receive routine clinical care.
No interventions assigned to this group
Interventions
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Patient Priorities Care
Patient Priorities Care (PPC) is an innovative approach to shared decision-making that draws from existing professional training.
PPC requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences. This information will be collected and documented in the EHR by facilitators and shared with the clinicians who will then use the PPC approach with patients to inform and guide treatment decisions.
The PCPs will be trained in decisional strategies that have been shown to help align care with patients' health priorities. While encouraged to use these decisional strategies, PCPs will be free to make the recommendations they feel most appropriate for each patient.
This intervention has been developed to be integrated seamlessly into usual care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. In the Cleveland Clinic patient population
3. In the clinician practices selected as intervention or usual care practice sites
4. Clinically identified by: Those who meet any of several criteria i. 3 chronic conditions (See appendix 0 for the complete list) ii. 10 medications iii. \>2 ED visits over the past year iv. \>1 hospitalization (or \>10 days in hospital) v. receive any care coordination services vi. 2 specialists over past year
Exclusion Criteria
2. Advanced dementia or moderate to profound intellectual disabilities
3. Not English speaking
4. Nursing home resident
66 Years
ALL
No
Sponsors
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Yale University
OTHER
Donaghue Medical Research Foundation
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Ardeshir Hashmi
Center Director, Geriatrics
Principal Investigators
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Ardeshir Hashmi, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Lakewood Family Health Center
Lakewood, Ohio, United States
Countries
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References
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Boyd C, Smith CD, Masoudi FA, Blaum CS, Dodson JA, Green AR, Kelley A, Matlock D, Ouellet J, Rich MW, Schoenborn NL, Tinetti ME. Decision Making for Older Adults With Multiple Chronic Conditions: Executive Summary for the American Geriatrics Society Guiding Principles on the Care of Older Adults With Multimorbidity. J Am Geriatr Soc. 2019 Apr;67(4):665-673. doi: 10.1111/jgs.15809. Epub 2019 Mar 10.
Tinetti ME, Naik AD, Dindo L, Costello DM, Esterson J, Geda M, Rosen J, Hernandez-Bigos K, Smith CD, Ouellet GM, Kang G, Lee Y, Blaum C. Association of Patient Priorities-Aligned Decision-Making With Patient Outcomes and Ambulatory Health Care Burden Among Older Adults With Multiple Chronic Conditions: A Nonrandomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1688-1697. doi: 10.1001/jamainternmed.2019.4235.
Z. Zhao, "Using matching to estimate treatment effects: Data requirements, matching metrics, and Monte Carlo evidence," in Review of Economics and Statistics, 2004, doi: 10.1162/003465304323023705.
D. B. Rubin, "Using Multivariate Matched Sampling and Regression Adjustment to Control Bias in Observational Studies," J. Am. Stat. Assoc., 1979, doi: 10.1080/01621459.1979.10482513.
Tran VT, Harrington M, Montori VM, Barnes C, Wicks P, Ravaud P. Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform. BMC Med. 2014 Jul 2;12:109. doi: 10.1186/1741-7015-12-109.
Hahn EA, Kallen MA, Jensen RE, Potosky AL, Moinpour CM, Ramirez M, Cella D, Teresi JA. Measuring social function in diverse cancer populations: Evaluation of measurement equivalence of the Patient Reported Outcomes Measurement Information System(R) (PROMIS(R)) Ability to Participate in Social Roles and Activities short form. Psychol Test Assess Model. 2016 Jun 27;58(2):403-421.
Groff AC, Colla CH, Lee TH. Days Spent at Home - A Patient-Centered Goal and Outcome. N Engl J Med. 2016 Oct 27;375(17):1610-1612. doi: 10.1056/NEJMp1607206. No abstract available.
Russell LB, Ibuka Y, Carr D. How Much Time Do Patients Spend on Outpatient Visits?: The American Time Use Survey. Patient. 2008 Jul 1;1(3):211-22. doi: 10.2165/1312067-200801030-00008.
Forcino RC, Barr PJ, O'Malley AJ, Arend R, Castaldo MG, Ozanne EM, Percac-Lima S, Stults CD, Tai-Seale M, Thompson R, Elwyn G. Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States. Health Expect. 2018 Feb;21(1):82-89. doi: 10.1111/hex.12588. Epub 2017 Jul 5.
Blaum CS, Rosen J, Naik AD, Smith CD, Dindo L, Vo L, Hernandez-Bigos K, Esterson J, Geda M, Ferris R, Costello D, Acampora D, Meehan T, Tinetti ME. Feasibility of Implementing Patient Priorities Care for Older Adults with Multiple Chronic Conditions. J Am Geriatr Soc. 2018 Oct;66(10):2009-2016. doi: 10.1111/jgs.15465. Epub 2018 Oct 3.
Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.
D. B. Rubin, "Using propensity scores to help design observational studies: Application to the tobacco litigation," Matched Sampl. Causal Eff., pp. 365-382, 2006, doi:
Stuart EA. Matching methods for causal inference: A review and a look forward. Stat Sci. 2010 Feb 1;25(1):1-21. doi: 10.1214/09-STS313.
Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
D. Rubin, Multiple Imputation for Nonresponse in Surveys. Wiley, 1987.
J. Cohen, Statistical Power Analysis for the Behavioral Sciences. Hillsdale, New Jersey, 1988.
Tinetti M, Dindo L, Smith CD, Blaum C, Costello D, Ouellet G, Rosen J, Hernandez-Bigos K, Geda M, Naik A. Challenges and strategies in patients' health priorities-aligned decision-making for older adults with multiple chronic conditions. PLoS One. 2019 Jun 10;14(6):e0218249. doi: 10.1371/journal.pone.0218249. eCollection 2019.
Tinetti ME, Hashmi A, Ng H, Doyle M, Goto T, Esterson J, Naik AD, Dindo L, Li F. Patient Priorities-Aligned Care for Older Adults With Multiple Conditions: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352666. doi: 10.1001/jamanetworkopen.2023.52666.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Patient Priorities Care helps patients and clinicians focus all decision-making and healthcare on what matters most: patients' own health priorities. It was developed by clinicians, patients, caregivers, health system leaders, and payers.
Other Identifiers
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20-555
Identifier Type: -
Identifier Source: org_study_id
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