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Multiple Chronic ConditionsPPC-CCFNCT04510948

Patient Priority Care for Older Adults With Multiple Chronic Conditions

A study testing Patient Priorities Care in people with Multiple Chronic Conditions, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 66 years and older
Conditions the study is for
Multiple Chronic Conditions
What is being tested?
Patient Priorities Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteUnited States
Study dates
14 Aug 2020to 30 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 66 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic Lakewood Family Health Center

    Lakewood, Ohio, 44107

Other trials in United States

About this study

Official title: Patient Priority Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment

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.

Read the detailed description

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) is an approach that aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each is willing and able to receive). PPC offers the opportunity to increase value by improving both outputs (desired health outcomes) and inputs (healthcare preferences) for these major users of healthcare.

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.

Being tested
Patient Priorities Care
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Priorities CareBehavioural

    Also called PPC

    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.

Study groups in NCT04510948
Study groupRoleWhat they receive
Intervention (Implementing Patient Priorities Care)ExperimentalPatient 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.
Receives: Behavioral: Patient Priorities Care
Usual Care (Not implementing PPC)No interventionPatients will receive routine clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from baseline to follow-up at 8-9 months

  2. 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.

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

  3. 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.

    Measured: from 3 months prior to 12 months following baseline interview

Secondary outcomes (1)
  1. Shared Decision Making and Goal Ascertainment

    Change in patient score on CollaboRATE tool (score 0-100, Cronbach's alpha=0.89) from baseline to follow-up up at 8-9 months and response to Cleveland Clinic ACO survey item "When starting a new medication, did your provider ask what you thought was best for you?" Scores are dichotomized 100 vs. <100 with 100 being the percent of participants who reported the top score of all three items.

    Measured: at 8-9 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start14 Aug 2020
  3. Primary completion15 Jan 2022
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510948
Sponsor's protocol ID
20-555
Acronym
PPC-CCF
Status last verified
May 2025
First submitted
11 Aug 2020
Last updated
4 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Dedientified data may be shared on a case-by-case basis after compliance and regulatory approval have been obtained.

Publications

  • 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.

    PubMed 30663782
  • 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.

    PubMed 31589281
  • 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.

    PubMed 24989988
  • 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.

    PubMed 30221102
  • 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.

    PubMed 27783911
  • 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.

    PubMed 22272927
  • 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.

    PubMed 28678426
  • 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.

    PubMed 30281777
  • 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.

    PubMed 26238958
  • 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.

    PubMed 20871802
  • 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.

    PubMed 21818162
  • D. Rubin, Multiple Imputation for Nonresponse in Surveys. Wiley, 1987.

Questions about this trial

What is this clinical trial studying?

A study testing Patient Priorities Care in people with Multiple Chronic Conditions, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Burden (time frame: from baseline to follow-up at 8-9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510948, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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