Improving Communication for Primary Care Patients

Dementia Clinical Trial

Official title:

Improving Communication for Primary Care Patients (SHARING Choices)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819191
• Other study ID #: IRB00224501
• Secondary ID: R33AG061882
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64988
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advance Care Planning
• Dementia

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	MedStar Medical Group at Alexandria	Alexandria	Virginia
United States	MedStar Greater Annapolis Medical Group	Annapolis	Maryland
United States	Family Health Center at MedStar Franklin Square Medical Center	Baltimore	Maryland
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Community Physicians - Canton Crossing	Baltimore	Maryland
United States	Johns Hopkins Community Physicians - Remington	Baltimore	Maryland
United States	MedStar Good Samaritan Hospital Medical Faculty Practice	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	MedStar Medical Group at Ridge Road	Baltimore	Maryland
United States	MedStar Medical Group at Wilkens Center	Baltimore	Maryland
United States	MedStar Union Memorial Adult Medicine Specialists at 33rd St.	Baltimore	Maryland
United States	The Center for Successful Aging at MedStar Good Samaritan Hospital	Baltimore	Maryland
United States	The Primary Care Center at MedStar Franklin Square Medical Center	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	MedStar Medical Group Primary Care at Fort Washington	Fort Washington	Maryland
United States	Johns Hopkins Community Physicians - Frederick	Frederick	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 - North Bethesda	Rockville	Maryland
United States	Johns Hopkins Community Physicians - Rockville (Montgomery Grove)	Rockville	Maryland
United States	MedStar Medical Group at Silver Spring	Silver Spring	Maryland
United States	Johns Hopkins Community Physicians - I Street	Washington	District of Columbia
United States	MedStar Georgetown University Hospital General Internal Medicine	Washington	District of Columbia
United States	MedStar Medical Group at Lafayette Centre	Washington	District of Columbia
United States	MedStar Medical Group at MedStar Washington Hospital Center	Washington	District of Columbia
United States	MedStar Medical Group at New Mexico Avenue	Washington	District of Columbia
United States	MedStar Washington Hospital Center Physician Group LLC	Washington	District of Columbia
United States	Johns Hopkins Community Physicians - Westminster	Westminster	Maryland
United States	Johns Hopkins Community Physicians - Charles County	White Plains	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Medstar Health Research Institute, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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 Co — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients 65 and older with 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
Primary	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