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Advance Care PlanningNCT04819191

Improving Communication for Primary Care Patients

A study testing SHARING Choices in people with Advance Care Planning and Dementia, run by Johns Hopkins University at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Advance Care Planning, Dementia
What is being tested?
SHARING Choices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64,915 participants
Where
54 sitesUnited States
Study dates
1 Mar 2021to 20 Nov 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • MedStar Medical Group at Alexandria

    Alexandria, Virginia, 22302

  • MedStar Greater Annapolis Medical Group

    Annapolis, Maryland, 21401

  • Johns Hopkins Community Physicians - Remington

    Baltimore, Maryland, 21211

  • MedStar Union Memorial Adult Medicine Specialists at 33rd St.

    Baltimore, Maryland, 21218

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Johns Hopkins Community Physicians - Canton Crossing

    Baltimore, Maryland, 21224

  • MedStar Medical Group at Wilkens Center

    Baltimore, Maryland, 21229

  • MedStar Health at Federal Hill

    Baltimore, Maryland, 21230

  • MedStar Medical Group at North Parkville Health Center

    Baltimore, Maryland, 21234

  • Family Health Center at MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

  • MedStar Medical Group at Ridge Road

    Baltimore, Maryland, 21237

  • The Primary Care Center at MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital Medical Faculty Practice

    Baltimore, Maryland, 21239

  • The Center for Successful Aging at MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • MedStar Medical Group at Old Emmorton Rd

    Bel Air, Maryland, 21015

  • Johns Hopkins Community Physicians - Water's Edge

    Belcamp, Maryland, 21017

  • Johns Hopkins Community Physicians - Downtown Bethesda

    Bethesda, Maryland, 20814

  • MedStar Medical Group at Bethesda

    Bethesda, Maryland, 20815

  • Johns Hopkins Community Physicians - Bowie

    Bowie, Maryland, 20715

  • MedStar Medical Group at MedStar Health at Brandywine

    Brandywine, Maryland, 20613

  • MedStar Medical Group Primary Care at Clinton

    Clinton, Maryland, 20735

  • Johns Hopkins Community Physicians - Howard County

    Columbia, Maryland, 21046

  • MedStar Medical Group at Dundalk Professional Center

    Dundalk, Maryland, 21222

  • Johns Hopkins Community Physicians - Annapolis

    Edgewater, Maryland, 21037

  • MedStar Medical Group at Dorsey Hall

    Ellicott City, Maryland, 21042

  • MedStar Medical Group at Forest Hill

    Forest Hill, Maryland, 21050

  • Johns Hopkins Community Physicians - Frederick

    Frederick, Maryland, 21702

  • MedStar Medical Group Primary Care at Fort Washington

    Ft. Washington, Maryland, 20744

  • Johns Hopkins Community Physicians - Fulton

    Fulton, Maryland, 20759

  • Johns Hopkins Community Physicians - Germantown

    Germantown, Maryland, 20876

  • Johns Hopkins Community Physicians - Glen Burnie

    Glen Burnie, Maryland, 21061

  • Johns Hopkins Community Physicians - Hagerstown

    Hagerstown, Maryland, 21742

  • MedStar Medical Group at Hyattsville

    Hyattsville, Maryland, 20782

  • MedStar Medical Group at Laurel

    Laurel, Maryland, 20707

  • MedStar Medical Group at St. Clement's

    Leonardtown, Maryland, 20650

  • MedStar Medical Group at St. Mary's

    Leonardtown, Maryland, 20650

  • Johns Hopkins Health Care & Surgery Center - Green Spring Station

    Lutherville, Maryland, 21093

  • MedStar Medical Group at Mitchellville

    Mitchellville, Maryland, 20721

  • Johns Hopkins Community Physicians - Odenton

    Odenton, Maryland, 21113

  • MedStar Medical Group 18111 Prince Philip

    Olney, Maryland, 20832

  • MedStar Medical Group at Olney Professional Park

    Olney, Maryland, 20832

  • MedStar Medical Group Family Practice at Olney

    Olney, Maryland, 20832

  • MedStar Medical Group at Honeygo Center

    Perry Hall, Maryland, 21128

  • Johns Hopkins Community Physicians - Rockville (Montgomery Grove)

    Rockville, Maryland, 20850

  • Johns Hopkins Community Physicians - North Bethesda

    Rockville, Maryland, 20852

  • MedStar Medical Group at Silver Spring

    Silver Spring, Maryland, 20902

  • Johns Hopkins Community Physicians - I Street

    Washington D.C., District of Columbia, 20005

  • MedStar Georgetown University Hospital General Internal Medicine

    Washington D.C., District of Columbia, 20007

  • MedStar Medical Group at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • MedStar Washington Hospital Center Physician Group LLC

    Washington D.C., District of Columbia, 20010

  • MedStar Medical Group at New Mexico Avenue

    Washington D.C., District of Columbia, 20016

  • MedStar Medical Group at Lafayette Centre

    Washington D.C., District of Columbia, 20036

  • Johns Hopkins Community Physicians - Westminster

    Westminster, Maryland, 21157

  • Johns Hopkins Community Physicians - Charles County

    White Plains, Maryland, 20695

Other trials in United States

About this study

Official title: Improving Communication for Primary Care Patients (SHARING Choices)

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.
Read the 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.
Being tested
SHARING Choices
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHARING ChoicesBehavioural

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

Study groups in NCT04819191
Study groupRoleWhat they receive
SHARING ChoicesExperimentalComponents 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.
Receives: Behavioral: SHARING Choices
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 6 months preceding patient death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64,915 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819191
Sponsor's protocol ID
IRB00224501
Other IDs
R33AG061882
Status last verified
Feb 2025
First submitted
24 Mar 2021
Last updated
3 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The following materials will be shared with the research community. * Study Protocol * Statistical Analysis Plan (SAP) * Analytic Code

Publications

  • 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.

    PubMed 31486723

  • 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.

    PubMed 31925998

  • 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.

    PubMed 19820614

  • 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.

    PubMed 30022409

  • 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.

    PubMed 9487236

  • 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.

    PubMed 24325558

  • 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.

    PubMed 15011193

  • 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.

    PubMed 35690262

  • 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.

    PubMed 36398937

  • 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.

    PubMed 37100306

  • 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.

    PubMed 39226471

  • 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.

    PubMed 33325729

  • 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.

    PubMed 39211999

  • 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.

    PubMed 39621341

Questions about this trial

What is this clinical trial studying?

A study testing SHARING Choices in people with Advance Care Planning and Dementia, run by Johns Hopkins University at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819191, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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