Patient Priority Care for Older Adults With Multiple Chronic Conditions

NCT04510948 | Completed Results

• 1 other identifier: 20-555
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare for older adults with multiple chronic conditions (MCCs) is burdensome and of uncertain benefit, resulting in unwanted and unhelpful care. Patient Priorities Care (PPC) aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each is willing and able to receive). The aim of this project is to test, using a parallel group design involving 2 matched primary care sites, whether PPC decreases patient treatment burden and unwanted and unnecessary health care as well as assess what the value of this program is for patients.

Conditions

Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (3)

• Treatment Burden

  Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90) Lower score reflects less perceived treatment burden.

  from baseline to follow-up at 8-9 months

• Achievement of Desired Activities

  Patient score on PROMIS Ability to Participate in Social Roles and Activities Shot Form 6a (score range 6-30; Cronbach's alpha = 0.98) Higher score reflects more social participation.

  at follow-up (8-9 months) The scale instructions do not reference timeframe.

• Health Care Utilization Defined by Healthcare Contact Days

  Number of health care contact days defined as number of ED visits, days in hospital +.5\*number of outpatient encounters for procedures, tests, healthcare visits.

  from 3 months prior to 12 months following baseline interview

Secondary Outcomes (1)

• Shared Decision Making and Goal Ascertainment

  at 8-9 months follow-up

Study Arms (2)

Intervention (Implementing Patient Priorities Care)

EXPERIMENTAL

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.

Behavioral: Patient Priorities Care

Usual Care (Not implementing PPC)

NO INTERVENTION

Patients will receive routine clinical care.

Interventions

Patient Priorities Care BEHAVIORAL

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.

Also known as: PPC

Intervention (Implementing Patient Priorities Care)

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 66 and older
• In the Cleveland Clinic patient population
• In the clinician practices selected as intervention or usual care practice sites
• 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

You may not qualify if:

• In hospice or meeting hospice criteria for any condition
• Advanced dementia or moderate to profound intellectual disabilities
• Not English speaking
• Nursing home resident

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Yale University: collaborator
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

Cleveland Clinic Lakewood Family Health Center

Lakewood, Ohio, 44107, United States

Location

Related Publications (18)

• 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.

  PMID: 30663782 BACKGROUND

• 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.

  PMID: 31589281 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24989988 BACKGROUND

• 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.

  PMID: 30221102 BACKGROUND

• 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.

  PMID: 27783911 BACKGROUND

• 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.

  PMID: 22272927 BACKGROUND

• 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.

  PMID: 28678426 BACKGROUND

• 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.

  PMID: 30281777 BACKGROUND

• 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.

  PMID: 26238958 BACKGROUND

• 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:

  BACKGROUND

• 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.

  PMID: 20871802 BACKGROUND

• 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.

  PMID: 21818162 BACKGROUND

• D. Rubin, Multiple Imputation for Nonresponse in Surveys. Wiley, 1987.

  BACKGROUND

• J. Cohen, Statistical Power Analysis for the Behavioral Sciences. Hillsdale, New Jersey, 1988.

  BACKGROUND

• 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.

  PMID: 31181117 BACKGROUND

• 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.

  PMID: 38261319 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1\) Despite careful site selection by propensity-adjusted analyses, potential unmeasured confounders and persistent recruitment disparities despite efforts. 2) Methodological constraints and the impact of the COVID-19 pandemic (delays, disruptions, and reduced sample size) further limit generalizability and statistical power. 3) Participant enrollment issues and 9-month follow-up limitations add complexities. 4) While promising, the study's long-term impact on health outcomes remains uncertain.

Results Point of Contact

• Title: Mary Tinetti, MD
• Organization: Department of Medicine, Yale School of Medicine

MARY.TINETTI@yale.edu

203-688-5238

Study Officials

• Ardeshir Hashmi, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline and follow up interviews will be conducted by a rater blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director, Geriatrics

Model Details: The aim of this project is to test, using a parallel group design involving 2 matched primary care sites, whether PPC decreases patient treatment burden and unwanted and unnecessary health care as well as assess what the value of this program is for patients.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: August 14, 2020
• Primary Completion: January 15, 2022
• Study Completion: July 30, 2023
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication. Data will be retained for a period of six year after study closure.
• Access Criteria: Access will be provided on a case-by-case basis pending approval by the Cleveland Clinic IRB and law department.

Locations

US (1)