Trial Outcomes & Findings for Improving Communication for Primary Care Patients (NCT NCT04819191)
NCT ID: NCT04819191
Last Updated: 2025-03-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64915 participants
Primary outcome timeframe
1 year
Results posted on
2025-03-03
Participant Flow
Unit of analysis: Clinics
Participant milestones
| Measure |
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.
|
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 Usual Care received no intervention and provided standard care.
|
|---|---|---|
|
Overall Study
STARTED
|
22949 19
|
41966 32
|
|
Overall Study
Deceased Patients
|
542 19
|
1162 32
|
|
Overall Study
Deceased Patients With Serious Illness
|
364 19
|
682 32
|
|
Overall Study
COMPLETED
|
22949 19
|
41966 32
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Communication for Primary Care Patients
Baseline characteristics by cohort
| Measure |
SHARING Choices Sites
n=19 Clinics
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.
|
Usual Care
n=32 Clinics
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.
|
Total
n=51 Clinics
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
74.0 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
74.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13,575 Participants
n=5 Participants
|
25057 Participants
n=7 Participants
|
38632 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9374 Participants
n=5 Participants
|
16909 Participants
n=7 Participants
|
26283 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
7923 Participants
n=5 Participants
|
9984 Participants
n=7 Participants
|
17907 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
399 Participants
n=5 Participants
|
974 Participants
n=7 Participants
|
1373 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
12924 Participants
n=5 Participants
|
27421 Participants
n=7 Participants
|
40345 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1703 Participants
n=5 Participants
|
3587 Participants
n=7 Participants
|
5290 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22949 Participants
n=5 Participants
|
41966 Participants
n=7 Participants
|
64915 Participants
n=5 Participants
|
|
Area Deprivation Index
|
30.3 Scores on a scale
STANDARD_DEVIATION 23.2 • n=5 Participants
|
24.1 Scores on a scale
STANDARD_DEVIATION 19.0 • n=7 Participants
|
26.3 Scores on a scale
STANDARD_DEVIATION 20.8 • n=5 Participants
|
|
State of Residence
Maryland
|
19571 Participants
n=5 Participants
|
37380 Participants
n=7 Participants
|
56951 Participants
n=5 Participants
|
|
State of Residence
Virginia or Washington DC
|
2926 Participants
n=5 Participants
|
3017 Participants
n=7 Participants
|
5943 Participants
n=5 Participants
|
|
State of Residence
Other
|
452 Participants
n=5 Participants
|
1569 Participants
n=7 Participants
|
2021 Participants
n=5 Participants
|
|
Decedents (patients with diagnosis codes indicative of serious illness)
|
521 Participants
n=5 Participants
|
977 Participants
n=7 Participants
|
1498 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
SHARING Choices Sites
n=22949 Participants
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.
|
Usual Care
n=41966 Participants
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 Usual Care received no intervention and provided standard 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
|
166 Participants
|
206 Participants
|
|
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
|
2130 Participants
|
|
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
|
409 Participants
|
|
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
|
1010 Participants
|
PRIMARY outcome
Timeframe: 6 months preceding patient deathPopulation: Patients with diagnosis codes indicative of serious illness only
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.
Outcome measures
| Measure |
SHARING Choices Sites
n=521 Participants
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.
|
Usual Care
n=977 Participants
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 Usual Care received no intervention and provided standard care.
|
|---|---|---|
|
Occurrence of Potentially Burdensome Procedures Reported Within 6 Months
Potentially Burdensome Care at End-of-Life - Diagnosed Dementia
|
37 Participants
|
53 Participants
|
|
Occurrence of Potentially Burdensome Procedures Reported Within 6 Months
Potentially Burdensome Care at End-of-Life - Full Cohort
|
150 Participants
|
204 Participants
|
Adverse Events
SHARING Choices Sites
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Wolff, PhD
Johns Hopkins Bloomberg School of Public Health
Phone: (410) 502-0458
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place