Clinical trial NCT04819191: Improving Communication for Primary Care Patients
Official title: Improving Communication for Primary Care Patients (SHARING Choices)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Dementia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
name: National Institute on Aging (NIA)
First posted: 2021-03-26
Enrollment: 64915
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR)
timeFrame: 1 year
measure: Occurrence of Potentially Burdensome Procedures Reported Within 6 Months
timeFrame: 6 months preceding patient death
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Johns Hopkins Community Physicians - I Street
state: District of Columbia
city: Washington
country: United States
facility: MedStar Georgetown University Hospital General Internal Medicine
state: District of Columbia
city: Washington
country: United States
facility: MedStar Medical Group at MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center Physician Group LLC
state: District of Columbia
city: Washington
country: United States
facility: MedStar Medical Group at New Mexico Avenue
state: District of Columbia
city: Washington
country: United States
facility: MedStar Medical Group at Lafayette Centre
state: District of Columbia
city: Annapolis
country: United States
facility: MedStar Greater Annapolis Medical Group
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians - Remington
state: Maryland
city: Baltimore
country: United States
facility: MedStar Union Memorial Adult Medicine Specialists at 33rd St.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians - Canton Crossing
state: Maryland
city: Baltimore
country: United States
facility: MedStar Medical Group at Wilkens Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Health at Federal Hill
state: Maryland
city: Baltimore
country: United States
facility: MedStar Medical Group at North Parkville Health Center
state: Maryland
city: Baltimore
country: United States
facility: Family Health Center at MedStar Franklin Square Medical Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Medical Group at Ridge Road
state: Maryland
city: Baltimore
country: United States
facility: The Primary Care Center at MedStar Franklin Square Medical Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital Medical Faculty Practice
state: Maryland
city: Baltimore
country: United States
facility: The Center for Successful Aging at MedStar Good Samaritan Hospital
state: Maryland
city: Bel Air
country: United States
facility: MedStar Medical Group at Old Emmorton Rd
state: Maryland
city: Belcamp
country: United States
facility: Johns Hopkins Community Physicians - Water's Edge
state: Maryland
city: Bethesda
country: United States
facility: Johns Hopkins Community Physicians - Downtown Bethesda
state: Maryland
city: Bethesda
country: United States
facility: MedStar Medical Group at Bethesda
state: Maryland
city: Bowie
country: United States
facility: Johns Hopkins Community Physicians - Bowie
state: Maryland
city: Brandywine
country: United States
facility: MedStar Medical Group at MedStar Health at Brandywine
state: Maryland
city: Clinton
country: United States
facility: MedStar Medical Group Primary Care at Clinton
state: Maryland
city: Columbia
country: United States
facility: Johns Hopkins Community Physicians - Howard County
state: Maryland
city: Dundalk
country: United States
facility: MedStar Medical Group at Dundalk Professional Center
state: Maryland
city: Edgewater
country: United States
facility: Johns Hopkins Community Physicians - Annapolis
state: Maryland
city: Ellicott City
country: United States
facility: MedStar Medical Group at Dorsey Hall
state: Maryland
city: Forest Hill
country: United States
facility: MedStar Medical Group at Forest Hill
state: Maryland
city: Fort Washington
country: United States
facility: MedStar Medical Group Primary Care at Fort Washington
state: Maryland
city: Frederick
country: United States
facility: Johns Hopkins Community Physicians - Frederick
state: Maryland
city: Fulton
country: United States
facility: Johns Hopkins Community Physicians - Fulton
state: Maryland
city: Germantown
country: United States
facility: Johns Hopkins Community Physicians - Germantown
state: Maryland
city: Glen Burnie
country: United States
facility: Johns Hopkins Community Physicians - Glen Burnie
state: Maryland
city: Hagerstown
country: United States
facility: Johns Hopkins Community Physicians - Hagerstown
state: Maryland
city: Hyattsville
country: United States
facility: MedStar Medical Group at Hyattsville
state: Maryland
city: Laurel
country: United States
facility: MedStar Medical Group at Laurel
state: Maryland
city: Leonardtown
country: United States
facility: MedStar Medical Group at St. Clement's
state: Maryland
city: Leonardtown
country: United States
facility: MedStar Medical Group at St. Mary's
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Health Care & Surgery Center - Green Spring Station
state: Maryland
city: Mitchellville
country: United States
facility: MedStar Medical Group at Mitchellville
state: Maryland
city: Odenton
country: United States
facility: Johns Hopkins Community Physicians - Odenton
state: Maryland
city: Olney
country: United States
facility: MedStar Medical Group 18111 Prince Philip
state: Maryland
city: Olney
country: United States
facility: MedStar Medical Group at Olney Professional Park
state: Maryland
city: Olney
country: United States
facility: MedStar Medical Group Family Practice at Olney
state: Maryland
city: Perry Hall
country: United States
facility: MedStar Medical Group at Honeygo Center
state: Maryland
city: Rockville
country: United States
facility: Johns Hopkins Community Physicians - Rockville (Montgomery Grove)
state: Maryland
city: Rockville
country: United States
facility: Johns Hopkins Community Physicians - North Bethesda
state: Maryland
city: Silver Spring
country: United States
facility: MedStar Medical Group at Silver Spring
state: Maryland
city: Westminster
country: United States
facility: Johns Hopkins Community Physicians - Westminster
state: Maryland
city: White Plains
country: United States
facility: Johns Hopkins Community Physicians - Charles County
state: Maryland
city: Alexandria
country: United States
facility: MedStar Medical Group at Alexandria
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Jennifer Wolff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dy SM, Scerpella DL, Cotter V, Colburn J, Roth DL, McGuire M, Giovannetti ER, Walker KA, Hussain N, Sloan DH, Boyd CM, Cockey K, Sharma N, Saylor MA, Smith KM, Wolff JL; SHARING Choices investigators. SHARING Choices: Design and rationale for a pragmatic trial of an advance care planning intervention for older adults with and without dementia in primary care. Contemp Clin Trials. 2022 Aug;119:106818. doi: 10.1016/j.cct.2022.106818. Epub 2022 Jun 8.
citation: Smith KM, Scerpella D, Guo A, Hussain N, Colburn JL, Cotter VT, Aufill J, Dy SM, Wolff JL. Perceived Barriers and Facilitators of Implementing a Multicomponent Intervention to Improve Communication With Older Adults With and Without Dementia (SHARING Choices) in Primary Care: A Qualitative Study. J Prim Care Community Health. 2022 Jan-Dec;13:21501319221137251. doi: 10.1177/21501319221137251.
citation: Colburn JL, Scerpella DL, Chapin M, Walker KA, Dy SM, Saylor MA, Sharma N, Rebala S, Anderson RE, McGuire M, Hussain N, Rawlinson C, Cotter V, Cockey K, Roth DL, Nicholson KLC, Giovannetti ER, Sancho MB, Echavarria D, Boyd CM, Wolff JL, Smith KM. SHARING Choices: Lessons Learned from a Primary-Care Focused Advance Care Planning Intervention. J Pain Symptom Manage. 2023 Aug;66(2):e255-e264. doi: 10.1016/j.jpainsymman.2023.04.014. Epub 2023 Apr 25.
citation: Cotter VT, Sloan DH, Scerpella DL, Smith KM, Abshire Saylor M, Wolff JL. Feasibility of Using Simulation to Evaluate Implementation Fidelity in an Advance Care Planning Pragmatic Trial. Am J Hosp Palliat Care. 2024 Sep 3:10499091241282087. doi: 10.1177/10499091241282087. Online ahead of print.
citation: Wolff JL, Scerpella D, Cockey K, Hussain N, Funkhouser T, Echavarria D, Aufill J, Guo A, Sloan DH, Dy SM, Smith KM; SHARING Choices Investigators. SHARING Choices: A Pilot Study to Engage Family in Advance Care Planning of Older Adults With and Without Cognitive Impairment in the Primary Care Context. Am J Hosp Palliat Care. 2021 Nov;38(11):1314-1321. doi: 10.1177/1049909120978771. Epub 2020 Dec 16.
citation: Dy SM, Scerpella DL, Hanna V, Walker KA, Sloan DH, Green CM, Cotter V, Wolff JL, Giovannetti ER, McGuire M, Hussain N, Smith KM, Saylor MA. Qualitative evaluation of the SHARING Choices trial of primary care advance care planning for adults with and without dementia. J Am Geriatr Soc. 2024 Nov;72(11):3413-3426. doi: 10.1111/jgs.19154. Epub 2024 Aug 30.
citation: Wolff JL, Scerpella D, Giovannetti ER, Roth DL, Hanna V, Hussain N, Colburn JL, Saylor MA, Boyd CM, Cotter V, McGuire M, Rawlinson C, Sloan DH, Richards TM, Walker K, Smith KM, Dy SM; SHARING Choices Investigators. Advance Care Planning, End-of-Life Preferences, and Burdensome Care: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):162-170. doi: 10.1001/jamainternmed.2024.6215.