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Completed

NCT Number: NCT02986958

Involving Family to Improve Communication in Primary Care

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)

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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, Aberdeen, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pre-visit patient-family agenda-setting checklist

Other

Pre-visit patient-family agenda-setting checklist

Usual Care

Other

routine primary care

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Johns Hopkins Community Physicians
  • Medstar Health Research Institute

Registry information

Official study title

Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients

Acronym: SAMEPage

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Dec 31, 2018

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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