Improving Communication for Primary Care Patients

February 13, 2025 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64915

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
No Intervention: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients 65 and Older With New Documentation of Any Advance Directive in the Electronic Health Record (EHR)
Time Frame: 1 year
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
Time Frame: 6 months preceding patient 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. 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of potentially burdensome procedures reported within 6 months preceding death
Time Frame: 6 months preceding patient 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.
6 months preceding patient death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)
Medstar Health Research Institute

Investigators

  • Principal Investigator: Jennifer Wolff, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00224501
  • R33AG061882 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The following materials will be shared with the research community.

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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