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Involving Family to Improve Communication in Primary Care (SAMEPage)

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-visit patient-family agenda-setting checklist
Usual care
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Older adults: 65 years or older, established patient of participating primary care provider, regularly attend medical visits with one or more family member or unpaid friend "companion(s)", agree to allow companion to be contacted and participate in the study, authorize disclosure of Protected Health Information (PHI) in their electronic health record, able to provide informed consent or have a legally authorized representative
  • Companion: family member (spouse, adult child, parent, adult sibling) or unpaid friend who accompanies older adult participant to medical visits.
  • Primary care provider: practicing physician, nurse practitioner or physician assistant at a participating primary care practice.

Exclusion Criteria:

  • Older adults: younger than 65 years, no evidence of cognitive impairment, do not attend medical visits with family member or unpaid friend.
  • Companion: paid non-family member who accompanies patient to visits

Sites / Locations

  • Johns Hopkins Community Physicians
  • Medstar Center for Successful Aging
  • Johns Hopkins Community Physicians

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Checklist

Usual Care

Arm Description

One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider

Care as usual with their primary care provider

Outcomes

Primary Outcome Measures

Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)
Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.

Secondary Outcome Measures

Visit Duration
Duration of primary care visit in minutes
Patient Verbal Activity
Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.
Companion Verbal Activity
Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.
Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit
The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.
Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."

Full Information

First Posted
December 6, 2016
Last Updated
December 5, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins Community Physicians, Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02986958
Brief Title
Involving Family to Improve Communication in Primary Care
Acronym
SAMEPage
Official Title
Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins Community Physicians, Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates an agenda-setting checklist for patients with cognitive impairment and their family companions that is completed in the waiting room in advance of a primary care visit. The study team will conduct a two-group randomized trial to examine feasibility of the protocol and to compare medical communication (from visit audiotapes) during visits of patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who receive usual care (n=50)
Detailed Description
The study team has established proof of concept for a paper-pencil checklist to be used by older patients and their companions in the waiting room prior to medical visits. The checklist is designed to elicit and align patient and companion perspectives regarding patient health issues to discuss with the doctor, and to stimulate discussion about the companion's role in the visit. The premise for the checklist is that companions are typically motivated to support patients during medical visits, but that they often lack knowledge of the patient's health concerns and preferences for communication assistance. The study team will conduct a two group pilot randomized trial of up to 100 (50 per group) patients ages 65+ with cognitive impairment and their unpaid companion to test the effects of the refined checklist for medical communication. Each patient-companion dyad will be randomized to the intervention (to receive the checklist) or to a control protocol. The study will evaluate the feasibility of delivering the study protocol to patients with cognitive impairment and their companions in primary care, and to generate preliminary evidence regarding the effect of the checklist on medical communication. For these reasons, the control group protocol will comprise usual care which is in this case existing clinical practice. Patients (when feasible), companions, and doctors in both intervention and control groups will complete in-person post-visit surveys immediately after the visit. Patients (when feasible) and companions will separately complete follow-up surveys by telephone two weeks after the doctor visit conducted by a research staff member.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Checklist
Arm Type
Experimental
Arm Description
One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Care as usual with their primary care provider
Intervention Type
Other
Intervention Name(s)
Pre-visit patient-family agenda-setting checklist
Intervention Description
Pre-visit patient-family agenda-setting checklist
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
routine primary care
Primary Outcome Measure Information:
Title
Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)
Description
Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.
Time Frame
During enrollment visit, up to 77 minutes
Secondary Outcome Measure Information:
Title
Visit Duration
Description
Duration of primary care visit in minutes
Time Frame
During enrollment visit, up to 77 minutes
Title
Patient Verbal Activity
Description
Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.
Time Frame
During enrollment visit, up to 77 minutes
Title
Companion Verbal Activity
Description
Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.
Time Frame
During enrollment visit, up to 77 minutes
Title
Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit
Description
The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.
Time Frame
During enrollment visit, up to 77 minutes
Title
Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description
The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame
During Enrollment visit, up to 77 minutes
Title
Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description
The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame
During Enrollment visit, up to 77 minutes
Title
Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description
The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame
During Enrollment visit, up to 77 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older adults: 65 years or older, established patient of participating primary care provider, regularly attend medical visits with one or more family member or unpaid friend "companion(s)", agree to allow companion to be contacted and participate in the study, authorize disclosure of Protected Health Information (PHI) in their electronic health record, able to provide informed consent or have a legally authorized representative Companion: family member (spouse, adult child, parent, adult sibling) or unpaid friend who accompanies older adult participant to medical visits. Primary care provider: practicing physician, nurse practitioner or physician assistant at a participating primary care practice. Exclusion Criteria: Older adults: younger than 65 years, no evidence of cognitive impairment, do not attend medical visits with family member or unpaid friend. Companion: paid non-family member who accompanies patient to visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Wolff, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Community Physicians
City
Aberdeen
State/Province
Maryland
ZIP/Postal Code
21017
Country
United States
Facility Name
Medstar Center for Successful Aging
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
Johns Hopkins Community Physicians
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24417565
Citation
Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.
Results Reference
background
PubMed Identifier
27817986
Citation
Wolff JL, Guan Y, Boyd CM, Vick J, Amjad H, Roth DL, Gitlin LN, Roter DL. Examining the context and helpfulness of family companion contributions to older adults' primary care visits. Patient Educ Couns. 2017 Mar;100(3):487-494. doi: 10.1016/j.pec.2016.10.022. Epub 2016 Oct 25.
Results Reference
background
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
derived

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Involving Family to Improve Communication in Primary Care

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