An interventional study of Patient Priorities Care in Multiple Chronic Conditions, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 264 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Exclusion Criteria:
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
Patients will receive routine clinical 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.
Also known as: PPC
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.
Time frame: 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.
Time frame: 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.
Time frame: from 3 months prior to 12 months following baseline interview
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.
Time frame: at 8-9 months follow-up
Enrollment occurred between August 14, 2020 - May 14, 2021. The study followed a nonrandomized controlled trial design. One primary care site within Cleveland Clinic's multisite Primary Care Practice was selected as the PPC site. The UC site was identified as the optimal match to the PPC site using a multivariate matching procedure which calculated the multivariate distance between the PPC site and 11 potential UC sites.
| Milestone | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) |
|---|---|---|
| Started | 129 | 135 |
| Completed | 116 | 113 |
| Not completed | 13 | 22 |
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.
| score on a scale | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) |
|---|---|---|
| Baseline | 11.9 (10.3 to 13.6) | 11.6 (9.3 to 14.0) |
| Follow up | 12.7 (10.0 to 15.5) | 17.9 (13.1 to 22.7) |
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.
| score on a scale | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) |
|---|---|---|
| Achievement of Desired Activities | 21.9 (20.6 to 23.1) | 21.6 (20.2 to 22.9) |
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.
| days | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) |
|---|---|---|
| Baseline | 0.7 (0.4 to 1.0) | 0.7 (0.4 to 1.0) |
| Follow up | 8.7 (3.8 to 13.7) | 13.4 (6.6 to 20.1) |
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.
| score on a scale | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) |
|---|---|---|
| Baseline | 46.3 (36.5 to 56.5) | 47.7 (37.9 to 57.8) |
| Follow up | 58.5 (45.6 to 70.3) | 61.9 (50.9 to 71.8) |
Collected over From baseline and up to 1 year from baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Implementing Patient Priorities Care) | 3/129 (2.3%) | 0/129 (0%) | 0/129 (0%) |
| Usual Care (Not Implementing PPC) | 5/135 (3.7%) | 0/135 (0%) | 0/135 (0%) |
The number above includes respondents with some missing data. Although not all respondents answered all questions, all participants who responded completely at least one scale are included here. Raw numbers are reported.
| Age, Continuous(years) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Mean | 75.5 ± 6.4 | 75.4 ± 6.1 | 75.5 ± 6.3 |
| Sex: Female, Male(Participants) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Female | 54 | 66 | 120 |
| Male | 73 | 69 | 142 |
| Race (NIH/OMB)(Participants) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 1 | 11 |
| White | 110 | 129 | 239 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Education high school or less(Participants) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Count of participants | 25 | 46 | 71 |
| Medicare Advantage(Participants) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Count of participants | 59 | 63 | 122 |
| Lives alone(Participants) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Count of participants | 54 | 40 | 94 |
| 5-Word recall score(words) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Mean | 3.4 ± 1.4 | 3.7 ± 1.4 | 3.6 ± 1.4 |
| PROMIS physical health(units on a scale) | Intervention (Implementing Patient Priorities Care) | Usual Care (Not Implementing PPC) | Total |
|---|---|---|---|
| Mean | 14.8 ± 2.9 | 14.3 ± 2.7 | 14.6 ± 2.8 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Dedientified data may be shared on a case-by-case basis after compliance and regulatory approval have been obtained.
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.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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