Involving Family to Improve Communication in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: Pre-visit patient-family agenda-setting checklist
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Checklist<br>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<br>* Pre-visit patient-family agenda-setting checklist<br>|
| Placebo Comparator: Usual Care<br>Care as usual with their primary care provider | Other: Usual care<br>* routine primary care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During enrollment visit, up to 77 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visit Duration | Duration of primary care visit in minutes | During enrollment visit, up to 77 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. | During enrollment visit, up to 77 minutes | 
| 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. | During enrollment visit, up to 77 minutes | 
| 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. | During enrollment visit, up to 77 minutes | 
| 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. | During Enrollment visit, up to 77 minutes | 
| 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. | During Enrollment visit, up to 77 minutes | 
| 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. | During Enrollment visit, up to 77 minutes |