Improving Communication for Primary Care Patients

Sponsor
Johns Hopkins University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04819191
Collaborator
Medstar Health Research Institute (Other)
87,000
54
2
28
1611.1
57.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SHARING Choices
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
87000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Communication for Primary Care Patients (SHARING Choices)
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Usual care

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients 65 and older with documentation of any advance directive in the Electronic Health Record (EHR) [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.

Secondary Outcome Measures

  1. Occurrence of potentially burdensome procedures reported within 6 months preceding death [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Community Physicians - I Street Washington District of Columbia United States 20005
2 MedStar Georgetown University Hospital General Internal Medicine Washington District of Columbia United States 20007
3 MedStar Medical Group at MedStar Washington Hospital Center Washington District of Columbia United States 20010
4 MedStar Washington Hospital Center Physician Group LLC Washington District of Columbia United States 20010
5 MedStar Medical Group at New Mexico Avenue Washington District of Columbia United States 20016
6 MedStar Medical Group at Lafayette Centre Washington District of Columbia United States 20036
7 MedStar Greater Annapolis Medical Group Annapolis Maryland United States 21401
8 Johns Hopkins Community Physicians - Remington Baltimore Maryland United States 21211
9 MedStar Union Memorial Adult Medicine Specialists at 33rd St. Baltimore Maryland United States 21218
10 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
11 Johns Hopkins Community Physicians - Canton Crossing Baltimore Maryland United States 21224
12 MedStar Medical Group at Wilkens Center Baltimore Maryland United States 21229
13 MedStar Health at Federal Hill Baltimore Maryland United States 21230
14 MedStar Medical Group at North Parkville Health Center Baltimore Maryland United States 21234
15 Family Health Center at MedStar Franklin Square Medical Center Baltimore Maryland United States 21237
16 MedStar Medical Group at Ridge Road Baltimore Maryland United States 21237
17 The Primary Care Center at MedStar Franklin Square Medical Center Baltimore Maryland United States 21237
18 MedStar Good Samaritan Hospital Medical Faculty Practice Baltimore Maryland United States 21239
19 The Center for Successful Aging at MedStar Good Samaritan Hospital Baltimore Maryland United States 21239
20 MedStar Medical Group at Old Emmorton Rd Bel Air Maryland United States 21015
21 Johns Hopkins Community Physicians - Water's Edge Belcamp Maryland United States 21017
22 Johns Hopkins Community Physicians - Downtown Bethesda Bethesda Maryland United States 20814
23 MedStar Medical Group at Bethesda Bethesda Maryland United States 20815
24 Johns Hopkins Community Physicians - Bowie Bowie Maryland United States 20715
25 MedStar Medical Group at MedStar Health at Brandywine Brandywine Maryland United States 20613
26 MedStar Medical Group Primary Care at Clinton Clinton Maryland United States 20735
27 Johns Hopkins Community Physicians - Howard County Columbia Maryland United States 21046
28 MedStar Medical Group at Dundalk Professional Center Dundalk Maryland United States 21222
29 Johns Hopkins Community Physicians - Annapolis Edgewater Maryland United States 21037
30 MedStar Medical Group at Dorsey Hall Ellicott City Maryland United States 21042
31 MedStar Medical Group at Forest Hill Forest Hill Maryland United States 21050
32 MedStar Medical Group Primary Care at Fort Washington Fort Washington Maryland United States 20744
33 Johns Hopkins Community Physicians - Frederick Frederick Maryland United States 21702
34 Johns Hopkins Community Physicians - Fulton Fulton Maryland United States 20759
35 Johns Hopkins Community Physicians - Germantown Germantown Maryland United States 20876
36 Johns Hopkins Community Physicians - Glen Burnie Glen Burnie Maryland United States 21061
37 Johns Hopkins Community Physicians - Hagerstown Hagerstown Maryland United States 21742
38 MedStar Medical Group at Hyattsville Hyattsville Maryland United States 20782
39 MedStar Medical Group at Laurel Laurel Maryland United States 20707
40 MedStar Medical Group at St. Clement's Leonardtown Maryland United States 20650
41 MedStar Medical Group at St. Mary's Leonardtown Maryland United States 20650
42 Johns Hopkins Health Care & Surgery Center - Green Spring Station Lutherville Maryland United States 21093
43 MedStar Medical Group at Mitchellville Mitchellville Maryland United States 20721
44 Johns Hopkins Community Physicians - Odenton Odenton Maryland United States 21113
45 MedStar Medical Group 18111 Prince Philip Olney Maryland United States 20832
46 MedStar Medical Group at Olney Professional Park Olney Maryland United States 20832
47 MedStar Medical Group Family Practice at Olney Olney Maryland United States 20832
48 MedStar Medical Group at Honeygo Center Perry Hall Maryland United States 21128
49 Johns Hopkins Community Physicians - Rockville (Montgomery Grove) Rockville Maryland United States 20850
50 Johns Hopkins Community Physicians - North Bethesda Rockville Maryland United States 20852
51 MedStar Medical Group at Silver Spring Silver Spring Maryland United States 20902
52 Johns Hopkins Community Physicians - Westminster Westminster Maryland United States 21157
53 Johns Hopkins Community Physicians - Charles County White Plains Maryland United States 20695
54 MedStar Medical Group at Alexandria Alexandria Virginia United States 22302

Sponsors and Collaborators

  • Johns Hopkins University
  • Medstar Health Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04819191
Other Study ID Numbers:
  • IRB00224501
First Posted:
Mar 26, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022