Improving Communication for Primary Care Patients

NCT04819191 | Completed Results DMC

• 2 other identifiers: IRB00224501R33AG061882
• Study Type: interventional
• Target: 64,915
• Locations: 1 country
• Sites: 54

Brief Summary

This is a pragmatic trial of SHARING Choices. Components of SHARING Choices include:

1. 1.A letter from the clinic introducing an initiative to prepare persons and families for Advance Care Planning (ACP);
2. 2.Access to a facilitator trained to lead ACP discussions;
3. 3.Patient-family agenda-setting to align perspectives about the role of family and stimulate discussion about ACP;
4. 4.Facilitated registration to the patient portal (for patient and family) as desired;
5. 5.Education \& resources about Alzheimer's Disease and Related Dementias (ADRD) for clinic staff.

Conditions

Advance Care Planning; Dementia

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  6 months preceding patient death

Study Arms (2)

SHARING Choices

EXPERIMENTAL

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.

Behavioral: SHARING Choices

Usual care

NO INTERVENTION

Usual care

Interventions

SHARING Choices BEHAVIORAL

SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care

SHARING Choices

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Medstar Health Research Institute: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (54)

Johns Hopkins Community Physicians - I Street

Washington D.C., District of Columbia, 20005, United States

Location

MedStar Georgetown University Hospital General Internal Medicine

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Medical Group at MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Washington Hospital Center Physician Group LLC

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Medical Group at New Mexico Avenue

Washington D.C., District of Columbia, 20016, United States

Location

MedStar Medical Group at Lafayette Centre

Washington D.C., District of Columbia, 20036, United States

Location

MedStar Greater Annapolis Medical Group

Annapolis, Maryland, 21401, United States

Location

Johns Hopkins Community Physicians - Remington

Baltimore, Maryland, 21211, United States

Location

MedStar Union Memorial Adult Medicine Specialists at 33rd St.

Baltimore, Maryland, 21218, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Community Physicians - Canton Crossing

Baltimore, Maryland, 21224, United States

Location

MedStar Medical Group at Wilkens Center

Baltimore, Maryland, 21229, United States

Location

MedStar Health at Federal Hill

Baltimore, Maryland, 21230, United States

Location

MedStar Medical Group at North Parkville Health Center

Baltimore, Maryland, 21234, United States

Location

Family Health Center at MedStar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

MedStar Medical Group at Ridge Road

Baltimore, Maryland, 21237, United States

Location

The Primary Care Center at MedStar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

MedStar Good Samaritan Hospital Medical Faculty Practice

Baltimore, Maryland, 21239, United States

Location

The Center for Successful Aging at MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

MedStar Medical Group at Old Emmorton Rd

Bel Air, Maryland, 21015, United States

Location

Johns Hopkins Community Physicians - Water's Edge

Belcamp, Maryland, 21017, United States

Location

Johns Hopkins Community Physicians - Downtown Bethesda

Bethesda, Maryland, 20814, United States

Location

MedStar Medical Group at Bethesda

Bethesda, Maryland, 20815, United States

Location

Johns Hopkins Community Physicians - Bowie

Bowie, Maryland, 20715, United States

Location

MedStar Medical Group at MedStar Health at Brandywine

Brandywine, Maryland, 20613, United States

Location

MedStar Medical Group Primary Care at Clinton

Clinton, Maryland, 20735, United States

Location

Johns Hopkins Community Physicians - Howard County

Columbia, Maryland, 21046, United States

Location

MedStar Medical Group at Dundalk Professional Center

Dundalk, Maryland, 21222, United States

Location

Johns Hopkins Community Physicians - Annapolis

Edgewater, Maryland, 21037, United States

Location

MedStar Medical Group at Dorsey Hall

Ellicott City, Maryland, 21042, United States

Location

MedStar Medical Group at Forest Hill

Forest Hill, Maryland, 21050, United States

Location

Johns Hopkins Community Physicians - Frederick

Frederick, Maryland, 21702, United States

Location

MedStar Medical Group Primary Care at Fort Washington

Ft. Washington, Maryland, 20744, United States

Location

Johns Hopkins Community Physicians - Fulton

Fulton, Maryland, 20759, United States

Location

Johns Hopkins Community Physicians - Germantown

Germantown, Maryland, 20876, United States

Location

Johns Hopkins Community Physicians - Glen Burnie

Glen Burnie, Maryland, 21061, United States

Location

Johns Hopkins Community Physicians - Hagerstown

Hagerstown, Maryland, 21742, United States

Location

MedStar Medical Group at Hyattsville

Hyattsville, Maryland, 20782, United States

Location

MedStar Medical Group at Laurel

Laurel, Maryland, 20707, United States

Location

MedStar Medical Group at St. Clement's

Leonardtown, Maryland, 20650, United States

Location

MedStar Medical Group at St. Mary's

Leonardtown, Maryland, 20650, United States

Location

Johns Hopkins Health Care & Surgery Center - Green Spring Station

Lutherville, Maryland, 21093, United States

Location

MedStar Medical Group at Mitchellville

Mitchellville, Maryland, 20721, United States

Location

Johns Hopkins Community Physicians - Odenton

Odenton, Maryland, 21113, United States

Location

MedStar Medical Group 18111 Prince Philip

Olney, Maryland, 20832, United States

Location

MedStar Medical Group at Olney Professional Park

Olney, Maryland, 20832, United States

Location

MedStar Medical Group Family Practice at Olney

Olney, Maryland, 20832, United States

Location

MedStar Medical Group at Honeygo Center

Perry Hall, Maryland, 21128, United States

Location

Johns Hopkins Community Physicians - Rockville (Montgomery Grove)

Rockville, Maryland, 20850, United States

Location

Johns Hopkins Community Physicians - North Bethesda

Rockville, Maryland, 20852, United States

Location

MedStar Medical Group at Silver Spring

Silver Spring, Maryland, 20902, United States

Location

Johns Hopkins Community Physicians - Westminster

Westminster, Maryland, 21157, United States

Location

Johns Hopkins Community Physicians - Charles County

White Plains, Maryland, 20695, United States

Location

MedStar Medical Group at Alexandria

Alexandria, Virginia, 22302, United States

Location

Related Publications (14)

• 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.

  PMID: 31486723 BACKGROUND

• 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.

  PMID: 31925998 BACKGROUND

• 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.

  PMID: 19820614 BACKGROUND

• 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.

  PMID: 30022409 BACKGROUND

• 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.

  PMID: 9487236 BACKGROUND

• 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.

  PMID: 24325558 BACKGROUND

• 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.

  PMID: 15011193 BACKGROUND

• 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.

  PMID: 35690262 BACKGROUND

• 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.

  PMID: 36398937 BACKGROUND

• 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.

  PMID: 37100306 BACKGROUND

• 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.

  PMID: 39226471 BACKGROUND

• 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.

  PMID: 33325729 RESULT

• 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.

  PMID: 39211999 RESULT

• 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.

  PMID: 39621341 RESULT

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jennifer Wolff, PhD
• Organization: Johns Hopkins Bloomberg School of Public Health

jwolff2@jhu.edu

(410) 502-0458

Study Officials

• Jennifer Wolff, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: March 1, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (54)