Trial Outcomes & Findings for Involving Family to Improve Communication in Primary Care (NCT NCT02986958)

NCT ID: NCT02986958

Last Updated: 2018-12-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: During enrollment visit, up to 77 minutes
• Results posted on: 2018-12-31

Participant Flow

Participant milestones

Measure	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	Usual Care Care as usual with their primary care provider Usual care: routine primary care
Overall Study STARTED	49	44
Overall Study COMPLETED	49	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Involving Family to Improve Communication in Primary Care

Baseline characteristics by cohort

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care	Total n=93 Participants Total of all reporting groups
Age, Continuous	80.9 years STANDARD_DEVIATION 8.0 • n=113 Participants	78.8 years STANDARD_DEVIATION 7.1 • n=163 Participants	79.9 years STANDARD_DEVIATION 7.6 • n=160 Participants
Sex: Female, Male Female	24 Participants n=113 Participants	24 Participants n=163 Participants	48 Participants n=160 Participants
Sex: Female, Male Male	25 Participants n=113 Participants	20 Participants n=163 Participants	45 Participants n=160 Participants
Race/Ethnicity, Customized Nonwhite race or Hispanic ethnicity	18 Participants n=113 Participants	21 Participants n=163 Participants	39 Participants n=160 Participants
Mean Mini-Mental State Examination (MMSE)	20.8 units on a scale STANDARD_DEVIATION 7.8 • n=113 Participants	22.5 units on a scale STANDARD_DEVIATION 5.5 • n=163 Participants	21.6 units on a scale STANDARD_DEVIATION 6.8 • n=160 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)	0.86 Ratio Standard Error 0.42	0.68 Ratio Standard Error 0.45

SECONDARY outcome

Timeframe: During enrollment visit, up to 77 minutes

Duration of primary care visit in minutes

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Visit Duration	25.5 minutes Standard Error 12.5	24.8 minutes Standard Error 15.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Patient Verbal Activity	.226 Proportion of visit statements Standard Error 0.14	.271 Proportion of visit statements Standard Error 0.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Companion Verbal Activity	.228 Proportion of visit statements Standard Error 0.14	.182 Proportion of visit statements Standard Error 0.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit	17 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."

Outcome measures

Measure	Checklist n=43 Participants 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	Usual Care n=43 Participants Care as usual with their primary care provider Usual care: routine primary care
Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit	43 Participants	43 Participants

SECONDARY outcome

Timeframe: 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."

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=44 Participants Care as usual with their primary care provider Usual care: routine primary care
Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit	49 Participants	44 Participants

SECONDARY outcome

Timeframe: 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."

Outcome measures

Measure	Checklist n=49 Participants 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	Usual Care n=43 Participants Care as usual with their primary care provider Usual care: routine primary care
Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit	46 Participants	43 Participants

Adverse Events

Checklist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Program Manager

Johns Hopkins Bloomberg School of Public Health

Phone: 410-614-7910

Email: dechava1@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place