Study Results
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View full resultsBasic Information
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COMPLETED
NA
64915 participants
INTERVENTIONAL
2021-03-01
2023-11-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SHARING Choices
Components of SHARING Choices include:
A letter from the clinic introducing an initiative to prepare persons and families for Advance Care Planning (ACP); Access to a facilitator trained to lead ACP discussions; Patient-family agenda-setting to align perspectives about the role of family and stimulate discussion about ACP; Facilitated registration to the patient portal (for patient and family) as desired; Education \& resources about Alzheimer's Disease and Related Dementias (ADRD) for clinic staff.
SHARING Choices
SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care
Usual care
Usual care
No interventions assigned to this group
Interventions
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SHARING Choices
SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
Yes
Sponsors
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Medstar Health Research Institute
OTHER
National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Jennifer Wolff, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Community Physicians - I Street
Washington D.C., District of Columbia, United States
MedStar Georgetown University Hospital General Internal Medicine
Washington D.C., District of Columbia, United States
MedStar Medical Group at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center Physician Group LLC
Washington D.C., District of Columbia, United States
MedStar Medical Group at New Mexico Avenue
Washington D.C., District of Columbia, United States
MedStar Medical Group at Lafayette Centre
Washington D.C., District of Columbia, United States
MedStar Greater Annapolis Medical Group
Annapolis, Maryland, United States
Johns Hopkins Community Physicians - Remington
Baltimore, Maryland, United States
MedStar Union Memorial Adult Medicine Specialists at 33rd St.
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Community Physicians - Canton Crossing
Baltimore, Maryland, United States
MedStar Medical Group at Wilkens Center
Baltimore, Maryland, United States
MedStar Health at Federal Hill
Baltimore, Maryland, United States
MedStar Medical Group at North Parkville Health Center
Baltimore, Maryland, United States
Family Health Center at MedStar Franklin Square Medical Center
Baltimore, Maryland, United States
MedStar Medical Group at Ridge Road
Baltimore, Maryland, United States
The Primary Care Center at MedStar Franklin Square Medical Center
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital Medical Faculty Practice
Baltimore, Maryland, United States
The Center for Successful Aging at MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
MedStar Medical Group at Old Emmorton Rd
Bel Air, Maryland, United States
Johns Hopkins Community Physicians - Water's Edge
Belcamp, Maryland, United States
Johns Hopkins Community Physicians - Downtown Bethesda
Bethesda, Maryland, United States
MedStar Medical Group at Bethesda
Bethesda, Maryland, United States
Johns Hopkins Community Physicians - Bowie
Bowie, Maryland, United States
MedStar Medical Group at MedStar Health at Brandywine
Brandywine, Maryland, United States
MedStar Medical Group Primary Care at Clinton
Clinton, Maryland, United States
Johns Hopkins Community Physicians - Howard County
Columbia, Maryland, United States
MedStar Medical Group at Dundalk Professional Center
Dundalk, Maryland, United States
Johns Hopkins Community Physicians - Annapolis
Edgewater, Maryland, United States
MedStar Medical Group at Dorsey Hall
Ellicott City, Maryland, United States
MedStar Medical Group at Forest Hill
Forest Hill, Maryland, United States
Johns Hopkins Community Physicians - Frederick
Frederick, Maryland, United States
MedStar Medical Group Primary Care at Fort Washington
Ft. Washington, Maryland, United States
Johns Hopkins Community Physicians - Fulton
Fulton, Maryland, United States
Johns Hopkins Community Physicians - Germantown
Germantown, Maryland, United States
Johns Hopkins Community Physicians - Glen Burnie
Glen Burnie, Maryland, United States
Johns Hopkins Community Physicians - Hagerstown
Hagerstown, Maryland, United States
MedStar Medical Group at Hyattsville
Hyattsville, Maryland, United States
MedStar Medical Group at Laurel
Laurel, Maryland, United States
MedStar Medical Group at St. Clement's
Leonardtown, Maryland, United States
MedStar Medical Group at St. Mary's
Leonardtown, Maryland, United States
Johns Hopkins Health Care & Surgery Center - Green Spring Station
Lutherville, Maryland, United States
MedStar Medical Group at Mitchellville
Mitchellville, Maryland, United States
Johns Hopkins Community Physicians - Odenton
Odenton, Maryland, United States
MedStar Medical Group 18111 Prince Philip
Olney, Maryland, United States
MedStar Medical Group at Olney Professional Park
Olney, Maryland, United States
MedStar Medical Group Family Practice at Olney
Olney, Maryland, United States
MedStar Medical Group at Honeygo Center
Perry Hall, Maryland, United States
Johns Hopkins Community Physicians - Rockville (Montgomery Grove)
Rockville, Maryland, United States
Johns Hopkins Community Physicians - North Bethesda
Rockville, Maryland, United States
MedStar Medical Group at Silver Spring
Silver Spring, Maryland, United States
Johns Hopkins Community Physicians - Westminster
Westminster, Maryland, United States
Johns Hopkins Community Physicians - Charles County
White Plains, Maryland, United States
MedStar Medical Group at Alexandria
Alexandria, Virginia, United States
Countries
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References
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Walling AM, Sudore RL, Bell D, Tseng CH, Ritchie C, Hays RD, Gibbs L, Rahimi M, Sanz J, Wenger NS. Population-Based Pragmatic Trial of Advance Care Planning in Primary Care in the University of California Health System. J Palliat Med. 2019 Sep;22(S1):72-81. doi: 10.1089/jpm.2019.0142.
Wasp GT, Alam SS, Brooks GA, Khayal IS, Kapadia NS, Carmichael DQ, Austin AM, Barnato AE. End-of-life quality metrics among medicare decedents at minority-serving cancer centers: A retrospective study. Cancer Med. 2020 Mar;9(5):1911-1921. doi: 10.1002/cam4.2752. Epub 2020 Jan 11.
Barnato AE, Farrell MH, Chang CC, Lave JR, Roberts MS, Angus DC. Development and validation of hospital "end-of-life" treatment intensity measures. Med Care. 2009 Oct;47(10):1098-105. doi: 10.1097/MLR.0b013e3181993191.
Wolff JL, Roter DL, Boyd CM, Roth DL, Echavarria DM, Aufill J, Vick JB, Gitlin LN. Patient-Family Agenda Setting for Primary Care Patients with Cognitive Impairment: the SAME Page Trial. J Gen Intern Med. 2018 Sep;33(9):1478-1486. doi: 10.1007/s11606-018-4563-y. Epub 2018 Jul 18.
Hammes BJ, Rooney BL. Death and end-of-life planning in one midwestern community. Arch Intern Med. 1998 Feb 23;158(4):383-90. doi: 10.1001/archinte.158.4.383.
Pecanac KE, Repenshek MF, Tennenbaum D, Hammes BJ. Respecting Choices(R) and advance directives in a diverse community. J Palliat Med. 2014 Mar;17(3):282-7. doi: 10.1089/jpm.2013.0047. Epub 2013 Dec 10.
Briggs LA, Kirchhoff KT, Hammes BJ, Song MK, Colvin ER. Patient-centered advance care planning in special patient populations: a pilot study. J Prof Nurs. 2004 Jan-Feb;20(1):47-58. doi: 10.1016/j.profnurs.2003.12.001.
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.
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.
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.
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. 2025 Aug;42(8):785-791. doi: 10.1177/10499091241282087. Epub 2024 Sep 3.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00224501
Identifier Type: -
Identifier Source: org_study_id
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