Multiple Chronic Conditions
Conditions
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.
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.
Interventions
BEHAVIORALPatient 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.
Sponsors
Yale University
Donaghue Medical Research Foundation
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Baseline and follow up interviews will be conducted by a rater blinded to the group 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.
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 66 and older 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
1. In hospice or meeting hospice criteria for any condition 2. Advanced dementia or moderate to profound intellectual disabilities 3. Not English speaking 4. Nursing home resident
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Burden | 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) Lower score reflects less perceived treatment burden. |
| Achievement of Desired Activities | at follow-up (8-9 months) The scale instructions do not reference timeframe. | 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. |
| Health Care Utilization Defined by Healthcare Contact Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making and Goal Ascertainment | 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? Scores are dichotomized 100 vs. \<100 with 100 being the percent of participants who reported the top score of all three items. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention (Implementing Patient Priorities Care) Patient Priorities Care (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 (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.
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. | 129 |
| Usual Care (Not Implementing PPC) Patients will receive routine clinical care. No study intervention was provided before or during their scheduled visit. | 135 |
| Total | 264 |
Baseline characteristics
| Characteristic | Intervention (Implementing Patient Priorities Care) | Total | Usual Care (Not Implementing PPC) |
|---|---|---|---|
| 5-Word recall score | 3.4 words STANDARD_DEVIATION 1.4 | 3.6 words STANDARD_DEVIATION 1.4 | 3.7 words STANDARD_DEVIATION 1.4 |
| Age, Continuous | 75.5 years STANDARD_DEVIATION 6.4 | 75.5 years STANDARD_DEVIATION 6.3 | 75.4 years STANDARD_DEVIATION 6.1 |
| CollaboRATE top score | 48 Participants | 108 Participants | 60 Participants |
| COPD | 36 Participants | 65 Participants | 29 Participants |
| Education high school or less | 25 Participants | 71 Participants | 46 Participants |
| Heart failure | 17 Participants | 36 Participants | 19 Participants |
| Lives alone | 54 Participants | 94 Participants | 40 Participants |
| Medicare Advantage | 59 Participants | 122 Participants | 63 Participants |
| Number of chronic conditions, mean (+/- SD) | 6.0 condition(s) STANDARD_DEVIATION 2.3 | 6.1 condition(s) STANDARD_DEVIATION 2.2 | 6.1 condition(s) STANDARD_DEVIATION 2.1 |
| Number or oral prescription medications for chronic conditions, mean (+/- SD) | 8.5 medication(s) STANDARD_DEVIATION 3.9 | 8.2 medication(s) STANDARD_DEVIATION 3.5 | 8.0 medication(s) STANDARD_DEVIATION 3 |
| PROMIS mental health | 14.3 units on a scale STANDARD_DEVIATION 2.9 | 14.1 units on a scale STANDARD_DEVIATION 2.8 | 13.9 units on a scale STANDARD_DEVIATION 2.8 |
| PROMIS physical health | 14.8 units on a scale STANDARD_DEVIATION 2.9 | 14.6 units on a scale STANDARD_DEVIATION 2.8 | 14.3 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 11 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 110 Participants | 239 Participants | 129 Participants |
| Sex: Female, Male Female | 54 Participants | 120 Participants | 66 Participants |
| Sex: Female, Male Male | 73 Participants | 142 Participants | 69 Participants |
| The Treatment Burden Questionnaire (TBQ) score | 12.2 units on a scale STANDARD_DEVIATION 12.6 | 11.2 units on a scale STANDARD_DEVIATION 11.7 | 10.3 units on a scale STANDARD_DEVIATION 10.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 129 | 5 / 135 |
| other Total, other adverse events | 0 / 129 | 0 / 135 |
| serious Total, serious adverse events | 0 / 129 | 0 / 135 |
Outcome results
Primary
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.
Population: PROM IS Social Roles and Activities was inadvertently left out of the baseline interview.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention (Implementing Patient Priorities Care) | Achievement of Desired Activities | 21.9 score on a scale |
| Usual Care (Not Implementing PPC) | Achievement of Desired Activities | 21.6 score on a scale |
Primary
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
Population: Baseline refers to 90 days before enrollment; follow-up refers to 365 days after enrollment. Baseline measures of nonhealthy days include only encounter days.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention (Implementing Patient Priorities Care) | Health Care Utilization Defined by Healthcare Contact Days | Baseline | 0.7 days |
| Intervention (Implementing Patient Priorities Care) | Health Care Utilization Defined by Healthcare Contact Days | Follow up | 8.7 days |
| Usual Care (Not Implementing PPC) | Health Care Utilization Defined by Healthcare Contact Days | Baseline | 0.7 days |
| Usual Care (Not Implementing PPC) | Health Care Utilization Defined by Healthcare Contact Days | Follow up | 13.4 days |
Primary
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
Population: The baseline outcome is included to illustrate weighted balance of covariate before PPC is introduced, and the P values for the baseline outcome comparison are based on weighted and imputed data (same as the adjusted P values in Table 1).Of note, the baseline value of the outcome was included in outcome models at follow-up. Therefore, the difference between estimates for baseline and follow-up is not necessarily equal to the effect size reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention (Implementing Patient Priorities Care) | Treatment Burden | Baseline | 11.9 score on a scale |
| Intervention (Implementing Patient Priorities Care) | Treatment Burden | Follow up | 12.7 score on a scale |
| Usual Care (Not Implementing PPC) | Treatment Burden | Baseline | 11.6 score on a scale |
| Usual Care (Not Implementing PPC) | Treatment Burden | Follow up | 17.9 score on a scale |
Secondary
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
Population: All results reflect doubly robust imputed models. Variables used in propensity weighting included race, gender, education, and baseline measures of age, living alone, insurance, cognitive status, number of oral prescription medications, number of chronic conditions, heart failure, COPD, baseline PROMIS mental health and physical health, baseline TBQ, baseline CollaboRATE, baseline ACO shared prescribing decision-making quality measure, and Nonhealthy Days in 90 days prior to enrollment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention (Implementing Patient Priorities Care) | Shared Decision Making and Goal Ascertainment | Baseline | 46.3 score on a scale |
| Intervention (Implementing Patient Priorities Care) | Shared Decision Making and Goal Ascertainment | Follow up | 58.5 score on a scale |
| Usual Care (Not Implementing PPC) | Shared Decision Making and Goal Ascertainment | Baseline | 47.7 score on a scale |
| Usual Care (Not Implementing PPC) | Shared Decision Making and Goal Ascertainment | Follow up | 61.9 score on a scale |