Advance Care Planning, Dementia
Conditions
Brief summary
This is a pragmatic trial of SHARING Choices. Components of SHARING Choices include: 1. A letter from the clinic introducing an initiative to prepare persons and families for Advance Care Planning (ACP); 2. Access to a facilitator trained to lead ACP discussions; 3. Patient-family agenda-setting to align perspectives about the role of family and stimulate discussion about ACP; 4. Facilitated registration to the patient portal (for patient and family) as desired; 5. Education & resources about Alzheimer's Disease and Related Dementias (ADRD) for clinic staff.
Detailed description
Engaging family in primary care is particularly important in Alzheimer's Disease and Related Dementias (ADRD) because of the important role assumed in medical decision-making, especially at the end of life. The investigators, study seeks to improve communication in primary care through methods to proactively engage family in ongoing interactions with primary care and stimulate and support Advance Care Planning (ACP) for all older adults and attention to ADRD in primary care throughout the ADRD disease trajectory. The investigators' premise is that individuals and families appreciate primary care involvement in ACP and information and referrals for ADRD needs, but that individual, family, and system factors including time, knowledge, and resources often inhibit these conversations from occurring. SHARING Choices integrates communication strategies that have been individually found to be effective but have thus far been deployed in isolation of one another. The investigators focus on all older primary care patients because of the importance of addressing ACP early, the under-diagnosis of ADRD and the greater implementation potential of a protocol with broad applicability. Components of SHARING Choices include: 1. A letter from the clinic introducing an initiative to prepare persons and families for Advance Care Planning (ACP); 2. Access to a facilitator trained to lead ACP discussions; 3. Patient-family agenda-setting to align perspectives about the role of family and stimulate discussion about ACP; 4. Facilitated registration to the patient portal (for patient and family) as desired; 5. Education & resources about ADRD for clinic staff.
Interventions
BEHAVIORALSHARING Choices
SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care
Sponsors
Medstar Health Research Institute
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Practices included in this trial are: * Affiliated with Johns Hopkins Community Physicians (JHCP) or MedStar Health; * A primary care practice, defined as adult internal medicine, family medicine, or geriatric medicine; * Have 2 or more practicing clinicians; and * Have more than 500 patients aged 65 and over currently receiving care. Patients included in this trial are: * Age 65 and older, and * Established patient of primary care clinician at participating practice (\>1 prior visit at the clinic). There will be no formal enrollment of participants into this pragmatic trial as this is a clinic-level initiative that will be available and offered to all eligible patients at clinics randomized to the intervention.
Exclusion criteria
Primary care practices affiliated with Johns Hopkins Community Physicians (JHCP) or MedStar Health that are: * Not a primary care practice, defined as adult internal medicine, family medicine, or geriatric medicine; * Have fewer than 2 practicing clinicians; and * Have fewer than 500 patients aged 65 and over currently receiving care. Patients under the care of primary care practices affiliated with Johns Hopkins Community Physicians (JHCP) or MedStar Health that are: * Less than 65 years of age, or * Not established patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | 1 year | Advance directive will be defined as a durable power of attorney, living will, Maryland Medical Order for Life Sustaining Treatment (MOLST), or District of Columbia Medical Order for Sustaining Treatment (MOST) based on information that is recorded in each care delivery system's electronic medical record 12 months after study entry. The initial visit date for each candidate patient after the inception of the trial serves as the beginning of the 12-month observation period and will be used to construct comparable observation periods for candidate patients at both intervention and control groups. |
| Occurrence of Potentially Burdensome Procedures Reported Within 6 Months | 6 months preceding patient death | Potentially burdensome care will be measured as any (yes/no) procedures within the 6 months that precede death using dates and validated International Classification of Diseases (ICD)-10 codes for hospital services that will be extracted from CRISP, the regional health information exchange, which includes a repository of all hospital encounters in Maryland, Delaware, West Virginia, and the District of Columbia. Specific procedures and codes that will be used to reflect burdensome care include intubation and mechanical ventilation, tracheostomy, gastrostomy feeding tube placement, hemodialysis, enteral and parenteral nutrition, and cardiopulmonary resuscitation. Analysis limited to patients with diagnosis codes indicative of serious illness, for whom these procedures would be considered potentially burdensome, drawing from a list of ICD-10 codes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SHARING Choices Sites We used a covariate-constrained randomization (CCR) method to assure approximate balance on selected site characteristics across intervention and control groups. We assigned practices to intervention or control in a 1:2 ratio because control practices incur no study cost and having more control practices affords greater precision in study outcomes estimates.
SHARING Choices was embedded in randomized primary care practices between September 2020 and March 2021 in a phased process involving partnership and input from health system and primary care practice leaders and repeated meetings and contacts with clinicians and staff to socialize the study and refine workflows and monitoring.
The intervention comprises 5 components: 1) outreach from the primary care practice introducing SHARING Choices to prepare patients and families to engage in ACP conversations, 2) access to a facilitator trained in all elements of SHARING Choices, including Respecting CHOICES and leading ACP for persons with ADRD and their families, 3) person-family agenda-setting to align perspectives about the role of family and stimulate conversation about health care issues and ACP, 4) information about registration for the patient portal to enable and extend electronic interactions and information access to patients and family, and 5) ADRD educational materials and resources for staff and clinicians. | 22 |
| SHARING Choices Sites We used a covariate-constrained randomization (CCR) method to assure approximate balance on selected site characteristics across intervention and control groups. We assigned practices to intervention or control in a 1:2 ratio because control practices incur no study cost and having more control practices affords greater precision in study outcomes estimates.
SHARING Choices was embedded in randomized primary care practices between September 2020 and March 2021 in a phased process involving partnership and input from health system and primary care practice leaders and repeated meetings and contacts with clinicians and staff to socialize the study and refine workflows and monitoring.
The intervention comprises 5 components: 1) outreach from the primary care practice introducing SHARING Choices to prepare patients and families to engage in ACP conversations, 2) access to a facilitator trained in all elements of SHARING Choices, including Respecting CHOICES and leading ACP for persons with ADRD and their families, 3) person-family agenda-setting to align perspectives about the role of family and stimulate conversation about health care issues and ACP, 4) information about registration for the patient portal to enable and extend electronic interactions and information access to patients and family, and 5) ADRD educational materials and resources for staff and clinicians. | 19 |
| Usual Care We used a covariate-constrained randomization (CCR) method to assure approximate balance on selected site characteristics across intervention and control groups. We assigned practices to intervention or control in a 1:2 ratio because control practices incur no study cost and having more control practices affords greater precision in study outcomes estimates.
Primary care practices randomized to the Usual Care received no intervention and provided standard care. | 41 |
| Usual Care We used a covariate-constrained randomization (CCR) method to assure approximate balance on selected site characteristics across intervention and control groups. We assigned practices to intervention or control in a 1:2 ratio because control practices incur no study cost and having more control practices affords greater precision in study outcomes estimates.
Primary care practices randomized to the Usual Care received no intervention and provided standard care. | 32 |
| Total | 114 |
Baseline characteristics
| Characteristic | Usual Care | Total | SHARING Choices Sites |
|---|---|---|---|
| Age, Continuous | 74.0 years STANDARD_DEVIATION 7.1 | 74.0 years STANDARD_DEVIATION 7.1 | 73.9 years STANDARD_DEVIATION 7.2 |
| Area Deprivation Index | 24.1 Scores on a scale STANDARD_DEVIATION 19 | 26.3 Scores on a scale STANDARD_DEVIATION 20.8 | 30.3 Scores on a scale STANDARD_DEVIATION 23.2 |
| Decedents (patients with diagnosis codes indicative of serious illness) | 977 Participants | 1498 Participants | 521 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 9984 Participants | 17907 Participants | 7923 Participants |
| Race/Ethnicity, Customized Hispanic | 974 Participants | 1373 Participants | 399 Participants |
| Race/Ethnicity, Customized Other | 3587 Participants | 5290 Participants | 1703 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 27421 Participants | 40345 Participants | 12924 Participants |
| Region of Enrollment United States | 41966 Participants | 64915 Participants | 22949 Participants |
| Sex: Female, Male Female | 25057 Participants | 38632 Participants | 13,575 Participants |
| Sex: Female, Male Male | 16909 Participants | 26283 Participants | 9374 Participants |
| State of Residence Maryland | 37380 Participants | 56951 Participants | 19571 Participants |
| State of Residence Other | 1569 Participants | 2021 Participants | 452 Participants |
| State of Residence Virginia or Washington DC | 3017 Participants | 5943 Participants | 2926 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR)
Advance directive will be defined as a durable power of attorney, living will, Maryland Medical Order for Life Sustaining Treatment (MOLST), or District of Columbia Medical Order for Sustaining Treatment (MOST) based on information that is recorded in each care delivery system's electronic medical record 12 months after study entry. The initial visit date for each candidate patient after the inception of the trial serves as the beginning of the 12-month observation period and will be used to construct comparable observation periods for candidate patients at both intervention and control groups.
Time frame: 1 year
Population: New Advance Directive or MO(L)ST Among Patients Without Documentation At Baseline - Excluding patients who did have an existing Advance Directive or MO(L)ST at the time of entry to the study cohort. Participants who had new uploads of Advance Directives or MO(L)ST after baseline are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHARING Choices Sites | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive or MO(L)ST Among Patients Without Documentation At Baseline | 2190 Participants |
| SHARING Choices Sites | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive or MOLST Among Patients Without Documentation At Baseline - Diagnosed Dementia | 255 Participants |
| SHARING Choices Sites | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive Among Patients Without Documentation at Baseline | 1699 Participants |
| SHARING Choices Sites | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive Among Patients Without Documentation at Baseline - Diagnosed Dementia | 166 Participants |
| Usual Care | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive Among Patients Without Documentation at Baseline - Diagnosed Dementia | 206 Participants |
| Usual Care | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive or MO(L)ST Among Patients Without Documentation At Baseline | 2130 Participants |
| Usual Care | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive Among Patients Without Documentation at Baseline | 1010 Participants |
| Usual Care | Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) | NEW Advance Directive or MOLST Among Patients Without Documentation At Baseline - Diagnosed Dementia | 409 Participants |
Primary
Occurrence of Potentially Burdensome Procedures Reported Within 6 Months
Potentially burdensome care will be measured as any (yes/no) procedures within the 6 months that precede death using dates and validated International Classification of Diseases (ICD)-10 codes for hospital services that will be extracted from CRISP, the regional health information exchange, which includes a repository of all hospital encounters in Maryland, Delaware, West Virginia, and the District of Columbia. Specific procedures and codes that will be used to reflect burdensome care include intubation and mechanical ventilation, tracheostomy, gastrostomy feeding tube placement, hemodialysis, enteral and parenteral nutrition, and cardiopulmonary resuscitation. Analysis limited to patients with diagnosis codes indicative of serious illness, for whom these procedures would be considered potentially burdensome, drawing from a list of ICD-10 codes.
Time frame: 6 months preceding patient death
Population: Patients with diagnosis codes indicative of serious illness only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHARING Choices Sites | Occurrence of Potentially Burdensome Procedures Reported Within 6 Months | Potentially Burdensome Care at End-of-Life - Full Cohort | 150 Participants |
| SHARING Choices Sites | Occurrence of Potentially Burdensome Procedures Reported Within 6 Months | Potentially Burdensome Care at End-of-Life - Diagnosed Dementia | 37 Participants |
| Usual Care | Occurrence of Potentially Burdensome Procedures Reported Within 6 Months | Potentially Burdensome Care at End-of-Life - Full Cohort | 204 Participants |
| Usual Care | Occurrence of Potentially Burdensome Procedures Reported Within 6 Months | Potentially Burdensome Care at End-of-Life - Diagnosed Dementia | 53 Participants |