Patient Priority Care for Older Adults With Multiple Chronic Conditions (PPC-CCF)
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| ClinicalTrials.gov Identifier: NCT04510948 |
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Recruitment Status :
Enrolling by invitation
First Posted : August 12, 2020
Last Update Posted : July 20, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Chronic Conditions | Behavioral: Patient Priorities Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Outcomes Assessor) |
| Masking Description: | Baseline and follow up interviews will be conducted by a rater blinded to the group assignment. |
| Primary Purpose: | Treatment |
| Official Title: | Patient Priority Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment |
| Actual Study Start Date : | August 14, 2020 |
| Actual Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | May 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: 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 Name: PPC |
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No Intervention: Usual Care (Not implementing PPC)
Patients will receive routine clinical care.
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- Treatment burden [ Time Frame: from baseline to follow-up at 8-9 months ]Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90)
- Achievement of desired activities [ Time Frame: from baseline to follow-up at 8-9 months ]Change in patient score on PROMIS Ability to Participate in Social Roles and Activities Shot Form 6a (score range 6-30; Cronbach's alpha = 0.98)
- Health care utilization defined by healthcare contact days [ Time Frame: from 3 months prior to 12 months following baseline interview ]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
- Shared decision making and goal ascertainment [ Time Frame: at 8-9 months follow-up ]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?"
- Alignment of healthcare with patient preferences (coded based on review of EHR) [ Time Frame: Variable will be coded based on review of EHR covering the 12 months post baseline follow-up. ]Dichotomous variable indicating whether medications or self-management tasks were added or stopped per patient preference. Data will be abstracted using a data dictionary which guided abstraction in pilot studies.
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| Ages Eligible for Study: | 66 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- In hospice or meeting hospice criteria for any condition
- Advanced dementia or moderate to profound intellectual disabilities
- Not English speaking
- Nursing home resident
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510948
| United States, Ohio | |
| Cleveland Clinic Lakewood Family Health Center | |
| Lakewood, Ohio, United States, 44107 | |
| Principal Investigator: | Ardeshir Hashmi, MD | The Cleveland Clinic |
Publications:
| Responsible Party: | Ardeshir Hashmi, Center Director, Geriatrics, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT04510948 |
| Other Study ID Numbers: |
20-555 |
| First Posted: | August 12, 2020 Key Record Dates |
| Last Update Posted: | July 20, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Disease Multiple Chronic Conditions Pathologic Processes Chronic Disease Disease Attributes |