Clinical trial NCT02986958: Involving Family to Improve Communication in Primary Care
Official title: Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Community Physicians
name: Medstar Health Research Institute
First posted: 2016-12-08
Enrollment: 93
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)
timeFrame: During enrollment visit, up to 77 minutes
Secondary outcomes:
measure: Visit Duration
timeFrame: During enrollment visit, up to 77 minutes
measure: Patient Verbal Activity
timeFrame: During enrollment visit, up to 77 minutes
measure: Companion Verbal Activity
timeFrame: During enrollment visit, up to 77 minutes
measure: Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit
timeFrame: During enrollment visit, up to 77 minutes
measure: Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
timeFrame: During Enrollment visit, up to 77 minutes
measure: Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
timeFrame: During Enrollment visit, up to 77 minutes
measure: Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
timeFrame: During Enrollment visit, up to 77 minutes
Other outcomes:
Locations:
city: Aberdeen
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
city: Baltimore
country: United States
facility: Medstar Center for Successful Aging
state: Maryland
city: Westminster
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Jennifer L Wolff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.