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Improving Communication for Primary Care Patients

Primary Purpose

Advance Care Planning, Dementia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHARING Choices
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Advance Care Planning

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Community Physicians - I Street
  • MedStar Georgetown University Hospital General Internal Medicine
  • MedStar Medical Group at MedStar Washington Hospital Center
  • MedStar Washington Hospital Center Physician Group LLC
  • MedStar Medical Group at New Mexico Avenue
  • MedStar Medical Group at Lafayette Centre
  • MedStar Greater Annapolis Medical Group
  • Johns Hopkins Community Physicians - Remington
  • MedStar Union Memorial Adult Medicine Specialists at 33rd St.
  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Community Physicians - Canton Crossing
  • MedStar Medical Group at Wilkens Center
  • MedStar Health at Federal Hill
  • MedStar Medical Group at North Parkville Health Center
  • Family Health Center at MedStar Franklin Square Medical Center
  • MedStar Medical Group at Ridge Road
  • The Primary Care Center at MedStar Franklin Square Medical Center
  • MedStar Good Samaritan Hospital Medical Faculty Practice
  • The Center for Successful Aging at MedStar Good Samaritan Hospital
  • MedStar Medical Group at Old Emmorton Rd
  • Johns Hopkins Community Physicians - Water's Edge
  • Johns Hopkins Community Physicians - Downtown Bethesda
  • MedStar Medical Group at Bethesda
  • Johns Hopkins Community Physicians - Bowie
  • MedStar Medical Group at MedStar Health at Brandywine
  • MedStar Medical Group Primary Care at Clinton
  • Johns Hopkins Community Physicians - Howard County
  • MedStar Medical Group at Dundalk Professional Center
  • Johns Hopkins Community Physicians - Annapolis
  • MedStar Medical Group at Dorsey Hall
  • MedStar Medical Group at Forest Hill
  • MedStar Medical Group Primary Care at Fort Washington
  • Johns Hopkins Community Physicians - Frederick
  • Johns Hopkins Community Physicians - Fulton
  • Johns Hopkins Community Physicians - Germantown
  • Johns Hopkins Community Physicians - Glen Burnie
  • Johns Hopkins Community Physicians - Hagerstown
  • MedStar Medical Group at Hyattsville
  • MedStar Medical Group at Laurel
  • MedStar Medical Group at St. Clement's
  • MedStar Medical Group at St. Mary's
  • Johns Hopkins Health Care & Surgery Center - Green Spring Station
  • MedStar Medical Group at Mitchellville
  • Johns Hopkins Community Physicians - Odenton
  • MedStar Medical Group 18111 Prince Philip
  • MedStar Medical Group at Olney Professional Park
  • MedStar Medical Group Family Practice at Olney
  • MedStar Medical Group at Honeygo Center
  • Johns Hopkins Community Physicians - Rockville (Montgomery Grove)
  • Johns Hopkins Community Physicians - North Bethesda
  • MedStar Medical Group at Silver Spring
  • Johns Hopkins Community Physicians - Westminster
  • Johns Hopkins Community Physicians - Charles County
  • MedStar Medical Group at Alexandria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SHARING Choices

Usual care

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of potentially burdensome procedures reported within 6 months preceding death
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. We limit our analysis of this measure 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.

Full Information

First Posted
March 24, 2021
Last Updated
July 17, 2023
Sponsor
Johns Hopkins University
Collaborators
Medstar Health Research Institute, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04819191
Brief Title
Improving Communication for Primary Care Patients
Official Title
Improving Communication for Primary Care Patients (SHARING Choices)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Medstar Health Research Institute, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pragmatic trial of 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.
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: 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 ADRD for clinic staff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning, Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHARING Choices
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
SHARING Choices
Intervention Description
SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care
Primary Outcome Measure Information:
Title
Proportion of patients 65 and older with documentation of any advance directive in the Electronic Health Record (EHR)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Occurrence of potentially burdensome procedures reported within 6 months preceding death
Description
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. We limit our analysis of this measure 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.
Time Frame
6 months preceding patient death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Wolff, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Community Physicians - I Street
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
MedStar Georgetown University Hospital General Internal Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Medical Group at MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
MedStar Washington Hospital Center Physician Group LLC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
MedStar Medical Group at New Mexico Avenue
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
MedStar Medical Group at Lafayette Centre
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
MedStar Greater Annapolis Medical Group
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Johns Hopkins Community Physicians - Remington
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Facility Name
MedStar Union Memorial Adult Medicine Specialists at 33rd St.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Johns Hopkins Community Physicians - Canton Crossing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
MedStar Medical Group at Wilkens Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
MedStar Health at Federal Hill
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21230
Country
United States
Facility Name
MedStar Medical Group at North Parkville Health Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21234
Country
United States
Facility Name
Family Health Center at MedStar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
MedStar Medical Group at Ridge Road
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
The Primary Care Center at MedStar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
MedStar Good Samaritan Hospital Medical Faculty Practice
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
The Center for Successful Aging at MedStar Good Samaritan Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
MedStar Medical Group at Old Emmorton Rd
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21015
Country
United States
Facility Name
Johns Hopkins Community Physicians - Water's Edge
City
Belcamp
State/Province
Maryland
ZIP/Postal Code
21017
Country
United States
Facility Name
Johns Hopkins Community Physicians - Downtown Bethesda
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
MedStar Medical Group at Bethesda
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Johns Hopkins Community Physicians - Bowie
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20715
Country
United States
Facility Name
MedStar Medical Group at MedStar Health at Brandywine
City
Brandywine
State/Province
Maryland
ZIP/Postal Code
20613
Country
United States
Facility Name
MedStar Medical Group Primary Care at Clinton
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Johns Hopkins Community Physicians - Howard County
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21046
Country
United States
Facility Name
MedStar Medical Group at Dundalk Professional Center
City
Dundalk
State/Province
Maryland
ZIP/Postal Code
21222
Country
United States
Facility Name
Johns Hopkins Community Physicians - Annapolis
City
Edgewater
State/Province
Maryland
ZIP/Postal Code
21037
Country
United States
Facility Name
MedStar Medical Group at Dorsey Hall
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States
Facility Name
MedStar Medical Group at Forest Hill
City
Forest Hill
State/Province
Maryland
ZIP/Postal Code
21050
Country
United States
Facility Name
MedStar Medical Group Primary Care at Fort Washington
City
Fort Washington
State/Province
Maryland
ZIP/Postal Code
20744
Country
United States
Facility Name
Johns Hopkins Community Physicians - Frederick
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Johns Hopkins Community Physicians - Fulton
City
Fulton
State/Province
Maryland
ZIP/Postal Code
20759
Country
United States
Facility Name
Johns Hopkins Community Physicians - Germantown
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20876
Country
United States
Facility Name
Johns Hopkins Community Physicians - Glen Burnie
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Johns Hopkins Community Physicians - Hagerstown
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
MedStar Medical Group at Hyattsville
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
MedStar Medical Group at Laurel
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
MedStar Medical Group at St. Clement's
City
Leonardtown
State/Province
Maryland
ZIP/Postal Code
20650
Country
United States
Facility Name
MedStar Medical Group at St. Mary's
City
Leonardtown
State/Province
Maryland
ZIP/Postal Code
20650
Country
United States
Facility Name
Johns Hopkins Health Care & Surgery Center - Green Spring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
MedStar Medical Group at Mitchellville
City
Mitchellville
State/Province
Maryland
ZIP/Postal Code
20721
Country
United States
Facility Name
Johns Hopkins Community Physicians - Odenton
City
Odenton
State/Province
Maryland
ZIP/Postal Code
21113
Country
United States
Facility Name
MedStar Medical Group 18111 Prince Philip
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Facility Name
MedStar Medical Group at Olney Professional Park
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Facility Name
MedStar Medical Group Family Practice at Olney
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Facility Name
MedStar Medical Group at Honeygo Center
City
Perry Hall
State/Province
Maryland
ZIP/Postal Code
21128
Country
United States
Facility Name
Johns Hopkins Community Physicians - Rockville (Montgomery Grove)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Johns Hopkins Community Physicians - North Bethesda
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
MedStar Medical Group at Silver Spring
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Johns Hopkins Community Physicians - Westminster
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Johns Hopkins Community Physicians - Charles County
City
White Plains
State/Province
Maryland
ZIP/Postal Code
20695
Country
United States
Facility Name
MedStar Medical Group at Alexandria
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22302
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The following materials will be shared with the research community. Study Protocol Statistical Analysis Plan (SAP) Analytic Code
Citations:
PubMed Identifier
31486723
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.
Results Reference
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31925998
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Results Reference
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PubMed Identifier
30022409
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.
Results Reference
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PubMed Identifier
9487236
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.
Results Reference
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PubMed Identifier
24325558
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
33325729
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 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.
Results Reference
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PubMed Identifier
35690262
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.
Results Reference
derived

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Improving Communication for Primary Care Patients

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