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Completed

NCT Number: NCT04819191

Improving Communication for Primary Care Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Physicians - I Street, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Medstar Health Research Institute
  • National Institute on Aging (NIA)

Registry information

Official study title

Improving Communication for Primary Care Patients (SHARING Choices)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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