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Involving Family to Improve Communication in Primary Care (SAMEPage)

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ClinicalTrials.gov Identifier: NCT02986958
Recruitment Status : Completed
First Posted : December 8, 2016
Results First Posted : October 11, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
Johns Hopkins Community Physicians
Medstar Health Research Institute
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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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)

Condition or disease Intervention/treatment Phase
Cognitive Impairment Other: Pre-visit patient-family agenda-setting checklist Other: Usual care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Checklist
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
 Other: Pre-visit patient-family agenda-setting checklist
Pre-visit patient-family agenda-setting checklist
Placebo Comparator: Usual Care
Care as usual with their primary care provider
 Other: Usual care
routine primary care


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) [ Time Frame: During enrollment visit, up to 77 minutes ]
    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 :
  1. Visit Duration [ Time Frame: During enrollment visit, up to 77 minutes ]
    Duration of primary care visit in minutes

  2. Patient Verbal Activity [ Time Frame: During enrollment visit, up to 77 minutes ]
    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.

  3. Companion Verbal Activity [ Time Frame: During enrollment visit, up to 77 minutes ]
    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.

  4. Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit [ Time Frame: During enrollment visit, up to 77 minutes ]
    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.

  5. Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit [ Time Frame: During Enrollment visit, up to 77 minutes ]
    The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."

  6. Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit [ Time Frame: During Enrollment visit, up to 77 minutes ]
    The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."

  7. Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit [ Time Frame: During Enrollment visit, up to 77 minutes ]
    The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986958


Locations
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United States, Maryland
Johns Hopkins Community Physicians
Aberdeen, Maryland, United States, 21017
Medstar Center for Successful Aging
Baltimore, Maryland, United States, 21239
Johns Hopkins Community Physicians
Westminster, Maryland, United States, 21157
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Community Physicians
Medstar Health Research Institute
Investigators
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Principal Investigator: Jennifer L Wolff, PhD Johns Hopkins Bloomberg School of Public Health
  Study Documents (Full-Text)

Documents provided by Johns Hopkins Bloomberg School of Public Health:
Study Protocol and Statistical Analysis Plan  [PDF] June 24, 2016

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02986958    
Other Study ID Numbers: R21AG049967 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2016    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders