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Cognitive ImpairmentSAMEPageNCT02986958

Involving Family to Improve Communication in Primary Care

A study testing Pre-visit patient-family agenda-setting checklist in people with Cognitive Impairment, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cognitive Impairment
What is being tested?
Pre-visit patient-family agenda-setting checklist
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
3 sitesUnited States
Study dates
Aug 2016to Aug 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Johns Hopkins Community Physicians

    Aberdeen, Maryland, 21017

  • Medstar Center for Successful Aging

    Baltimore, Maryland, 21239

  • Johns Hopkins Community Physicians

    Westminster, Maryland, 21157

Other trials in United States

About this study

Official title: Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients

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)

Read the 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.

Being tested
Pre-visit patient-family agenda-setting checklist, Usual care
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-visit patient-family agenda-setting checklistOther

    Pre-visit patient-family agenda-setting checklist

  • Usual careOther

    routine primary care

Study groups in NCT02986958
Study groupRoleWhat they receive
ChecklistExperimentalOne-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
Receives: Other: Pre-visit patient-family agenda-setting checklist
Usual CarePlacebo comparatorCare as usual with their primary care provider
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During enrollment visit, up to 77 minutes

Secondary outcomes (7)

  1. Visit Duration

    Duration of primary care visit in minutes

    Measured: During enrollment visit, up to 77 minutes

  2. 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.

    Measured: During enrollment visit, up to 77 minutes

  3. 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.

    Measured: During enrollment visit, up to 77 minutes

  4. 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.

    Measured: During enrollment visit, up to 77 minutes

  5. 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."

    Measured: During Enrollment visit, up to 77 minutes

  6. 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."

    Measured: During Enrollment visit, up to 77 minutes

  7. 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."

    Measured: During Enrollment visit, up to 77 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986958
Sponsor's protocol ID
R21AG049967
Acronym
SAMEPage
Status last verified
Dec 2018
First submitted
6 Dec 2016
Last updated
31 Dec 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24417565

  • 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.

    PubMed 27817986

  • 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.

    PubMed 30022409

Questions about this trial

What is this clinical trial studying?

A study testing Pre-visit patient-family agenda-setting checklist in people with Cognitive Impairment, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02986958, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.

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