Improving Communication for Primary Care Patients

NCT ID: NCT04819191

Last Updated: 2025-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-11-20

Brief Summary

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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

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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.

Conditions

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Advance Care Planning Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type EXPERIMENTAL

SHARING Choices

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

MedStar Georgetown University Hospital General Internal Medicine

Washington D.C., District of Columbia, United States

Site Status

MedStar Medical Group at MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

MedStar Washington Hospital Center Physician Group LLC

Washington D.C., District of Columbia, United States

Site Status

MedStar Medical Group at New Mexico Avenue

Washington D.C., District of Columbia, United States

Site Status

MedStar Medical Group at Lafayette Centre

Washington D.C., District of Columbia, United States

Site Status

MedStar Greater Annapolis Medical Group

Annapolis, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Remington

Baltimore, Maryland, United States

Site Status

MedStar Union Memorial Adult Medicine Specialists at 33rd St.

Baltimore, Maryland, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Canton Crossing

Baltimore, Maryland, United States

Site Status

MedStar Medical Group at Wilkens Center

Baltimore, Maryland, United States

Site Status

MedStar Health at Federal Hill

Baltimore, Maryland, United States

Site Status

MedStar Medical Group at North Parkville Health Center

Baltimore, Maryland, United States

Site Status

Family Health Center at MedStar Franklin Square Medical Center

Baltimore, Maryland, United States

Site Status

MedStar Medical Group at Ridge Road

Baltimore, Maryland, United States

Site Status

The Primary Care Center at MedStar Franklin Square Medical Center

Baltimore, Maryland, United States

Site Status

MedStar Good Samaritan Hospital Medical Faculty Practice

Baltimore, Maryland, United States

Site Status

The Center for Successful Aging at MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Site Status

MedStar Medical Group at Old Emmorton Rd

Bel Air, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Water's Edge

Belcamp, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Downtown Bethesda

Bethesda, Maryland, United States

Site Status

MedStar Medical Group at Bethesda

Bethesda, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Bowie

Bowie, Maryland, United States

Site Status

MedStar Medical Group at MedStar Health at Brandywine

Brandywine, Maryland, United States

Site Status

MedStar Medical Group Primary Care at Clinton

Clinton, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Howard County

Columbia, Maryland, United States

Site Status

MedStar Medical Group at Dundalk Professional Center

Dundalk, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Annapolis

Edgewater, Maryland, United States

Site Status

MedStar Medical Group at Dorsey Hall

Ellicott City, Maryland, United States

Site Status

MedStar Medical Group at Forest Hill

Forest Hill, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Frederick

Frederick, Maryland, United States

Site Status

MedStar Medical Group Primary Care at Fort Washington

Ft. Washington, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Fulton

Fulton, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Germantown

Germantown, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Glen Burnie

Glen Burnie, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Hagerstown

Hagerstown, Maryland, United States

Site Status

MedStar Medical Group at Hyattsville

Hyattsville, Maryland, United States

Site Status

MedStar Medical Group at Laurel

Laurel, Maryland, United States

Site Status

MedStar Medical Group at St. Clement's

Leonardtown, Maryland, United States

Site Status

MedStar Medical Group at St. Mary's

Leonardtown, Maryland, United States

Site Status

Johns Hopkins Health Care & Surgery Center - Green Spring Station

Lutherville, Maryland, United States

Site Status

MedStar Medical Group at Mitchellville

Mitchellville, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Odenton

Odenton, Maryland, United States

Site Status

MedStar Medical Group 18111 Prince Philip

Olney, Maryland, United States

Site Status

MedStar Medical Group at Olney Professional Park

Olney, Maryland, United States

Site Status

MedStar Medical Group Family Practice at Olney

Olney, Maryland, United States

Site Status

MedStar Medical Group at Honeygo Center

Perry Hall, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Rockville (Montgomery Grove)

Rockville, Maryland, United States

Site Status

Johns Hopkins Community Physicians - North Bethesda

Rockville, Maryland, United States

Site Status

MedStar Medical Group at Silver Spring

Silver Spring, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Westminster

Westminster, Maryland, United States

Site Status

Johns Hopkins Community Physicians - Charles County

White Plains, Maryland, United States

Site Status

MedStar Medical Group at Alexandria

Alexandria, Virginia, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 31486723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31925998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19820614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30022409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9487236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24325558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15011193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35690262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36398937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37100306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39226471 (View on PubMed)

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.

Reference Type RESULT
PMID: 33325729 (View on PubMed)

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.

Reference Type RESULT
PMID: 39211999 (View on PubMed)

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.

Reference Type RESULT
PMID: 39621341 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R33AG061882

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00224501

Identifier Type: -

Identifier Source: org_study_id

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Decision Support AMPATH
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