Cognitive Impairment
Conditions
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.
Interventions
OTHERPre-visit patient-family agenda-setting checklist
Pre-visit patient-family agenda-setting checklist
OTHERUsual care
routine primary care
Sponsors
Johns Hopkins Community Physicians
Medstar Health Research Institute
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Verbal Activity | 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. |
| Companion Verbal Activity | 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. |
| Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit | 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. |
| Visit Duration | During enrollment visit, up to 77 minutes | Duration of primary care visit in minutes |
| Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 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. |
| Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 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. |
| Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist | 49 |
| Usual Care Care as usual with their primary care provider
Usual care: routine primary care | 44 |
| Total | 93 |
Baseline characteristics
| Characteristic | Checklist | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 80.9 years STANDARD_DEVIATION 8 | 78.8 years STANDARD_DEVIATION 7.1 | 79.9 years STANDARD_DEVIATION 7.6 |
| Mean Mini-Mental State Examination (MMSE) | 20.8 units on a scale STANDARD_DEVIATION 7.8 | 22.5 units on a scale STANDARD_DEVIATION 5.5 | 21.6 units on a scale STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Nonwhite race or Hispanic ethnicity | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 25 Participants | 20 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 44 |
| other Total, other adverse events | 0 / 49 | 0 / 44 |
| serious Total, serious adverse events | 0 / 49 | 0 / 44 |
Outcome results
Primary
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.
Time frame: During enrollment visit, up to 77 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Checklist | Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) | 0.86 Ratio | Standard Error 0.42 |
| Usual Care | Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) | 0.68 Ratio | Standard Error 0.45 |
p-value: 0.046t-test, 2 sided
Secondary
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.
Time frame: During enrollment visit, up to 77 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Checklist | Companion Verbal Activity | .228 Proportion of visit statements | Standard Error 0.14 |
| Usual Care | Companion Verbal Activity | .182 Proportion of visit statements | Standard Error 0.12 |
Secondary
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.
Time frame: During Enrollment visit, up to 77 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Checklist | Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 49 Participants |
| Usual Care | Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 44 Participants |
Secondary
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.
Time frame: During enrollment visit, up to 77 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Checklist | Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit | 17 Participants |
| Usual Care | Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit | 16 Participants |
Secondary
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.
Time frame: During Enrollment visit, up to 77 minutes
Population: The number of patient participants for this patient-reported outcome measure sums to 86 because 7 of the 93 total patient participants were too cognitively impaired to respond to the paper-pencil post-visit survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Checklist | Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 43 Participants |
| Usual Care | Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 43 Participants |
Secondary
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.
Time frame: During Enrollment visit, up to 77 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Checklist | Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 46 Participants |
| Usual Care | Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | 43 Participants |
Secondary
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.
Time frame: During enrollment visit, up to 77 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Checklist | Patient Verbal Activity | .226 Proportion of visit statements | Standard Error 0.14 |
| Usual Care | Patient Verbal Activity | .271 Proportion of visit statements | Standard Error 0.14 |
Secondary
Visit Duration
Duration of primary care visit in minutes
Time frame: During enrollment visit, up to 77 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Checklist | Visit Duration | 25.5 minutes | Standard Error 12.5 |
| Usual Care | Visit Duration | 24.8 minutes | Standard Error 15.2 |