Trial Outcomes & Findings for Negotiation Training for Caregiver Communication in AD (NCT NCT04837937)

NCT ID: NCT04837937

Last Updated: 2025-08-01

Results Overview

Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect/well-being, and negative change represents a decrease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

132 participants

Primary outcome timeframe

Baseline (pre-intervention) and 1 Month Post-intervention

Results posted on

2025-08-01

Participant Flow

Two participants consented but were not randomized to a condition. One of these participants did not complete baseline intake and was not randomized to a treatment. The other participant did complete baseline intake but did not complete the study phase which assigns participants to a condition (a unique hyperlink which assigns condition and treatment materials when opened- this participant did not open their link).

Participant milestones

Participant milestones
Measure
Universal
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Overall Study
STARTED
15
17
16
16
17
16
17
17
Overall Study
COMPLETED
15
15
15
15
16
15
17
16
Overall Study
NOT COMPLETED
0
2
1
1
1
1
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Negotiation Training for Caregiver Communication in AD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Total
n=131 Participants
Total of all reporting groups
Age, Continuous
58.33 Years
n=5 Participants
55.71 Years
n=7 Participants
56.81 Years
n=5 Participants
55.56 Years
n=4 Participants
48.76 Years
n=21 Participants
51.44 Years
n=8 Participants
53.23 Years
n=8 Participants
51.59 Years
n=24 Participants
53.64 Years
n=42 Participants
Sex/Gender, Customized
Sex/Gender · Female
12 Participants
n=5 Participants
14 Participants
n=7 Participants
13 Participants
n=5 Participants
12 Participants
n=4 Participants
11 Participants
n=21 Participants
13 Participants
n=8 Participants
15 Participants
n=8 Participants
11 Participants
n=24 Participants
101 Participants
n=42 Participants
Sex/Gender, Customized
Sex/Gender · Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
3 Participants
n=8 Participants
2 Participants
n=8 Participants
5 Participants
n=24 Participants
29 Participants
n=42 Participants
Sex/Gender, Customized
Sex/Gender · Non-Binary
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
0 Participants
n=8 Participants
3 Participants
n=24 Participants
10 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
16 Participants
n=7 Participants
11 Participants
n=5 Participants
14 Participants
n=4 Participants
16 Participants
n=21 Participants
12 Participants
n=8 Participants
15 Participants
n=8 Participants
13 Participants
n=24 Participants
111 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
1 Participants
n=24 Participants
10 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
6 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
3 Participants
n=8 Participants
5 Participants
n=8 Participants
6 Participants
n=24 Participants
39 Participants
n=42 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
11 Participants
n=7 Participants
9 Participants
n=5 Participants
9 Participants
n=4 Participants
10 Participants
n=21 Participants
11 Participants
n=8 Participants
10 Participants
n=8 Participants
11 Participants
n=24 Participants
80 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
2 Participants
n=8 Participants
0 Participants
n=24 Participants
5 Participants
n=42 Participants
Positive Affect and Well-Being
55.41 T-Score
STANDARD_DEVIATION 4.07 • n=5 Participants
56.22 T-Score
STANDARD_DEVIATION 6.97 • n=7 Participants
55.5 T-Score
STANDARD_DEVIATION 6.84 • n=5 Participants
56.83 T-Score
STANDARD_DEVIATION 7.23 • n=4 Participants
54.2 T-Score
STANDARD_DEVIATION 5.87 • n=21 Participants
52.83 T-Score
STANDARD_DEVIATION 5.66 • n=8 Participants
54.86 T-Score
STANDARD_DEVIATION 4.84 • n=8 Participants
53.9 T-Score
STANDARD_DEVIATION 5.92 • n=24 Participants
54.96 T-Score
STANDARD_DEVIATION 5.98 • n=42 Participants

PRIMARY outcome

Timeframe: Baseline (pre-intervention) and 1 Month Post-intervention

Population: All participants with available data at baseline and 1 month post-intervention assessments were analyzed.

Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect/well-being, and negative change represents a decrease.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in Neuro-QoL Positive Affect and Well-Being Score
Baseline (Pre-Intervention)
56.83 T-Score
Standard Deviation 7.23
54.2 T-Score
Standard Deviation 5.87
52.83 T-Score
Standard Deviation 5.66
54.86 T-Score
Standard Deviation 4.84
55.41 T-Score
Standard Deviation 4.07
56.22 T-Score
Standard Deviation 6.94
55.51 T-Score
Standard Deviation 6.84
53.9 T-Score
Standard Deviation 5.92
Change in Neuro-QoL Positive Affect and Well-Being Score
1 month Post Intervention
53.76 T-Score
Standard Deviation 6.84
54.51 T-Score
Standard Deviation 6.51
53.01 T-Score
Standard Deviation 5.19
54.69 T-Score
Standard Deviation 4.86
54.39 T-Score
Standard Deviation 5.59
55.74 T-Score
Standard Deviation 4.82
53.66 T-Score
Standard Deviation 6.22
54.45 T-Score
Standard Deviation 5.28

SECONDARY outcome

Timeframe: 1 months post-baseline

Population: All participants who were randomized and completed the 1 month post-intervention assessment are included in the change analysis (n=125).

The PROMIS Adult Emotional Distress-Anxiety scale measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness) in respondents during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). We deployed the four item short form, with scores ranging from 4-20, with higher scores indicating greater severity of anxiety. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in PROMIS Anxiety Score
-.04 Change in T-Score
Standard Deviation 6.87
-1.06 Change in T-Score
Standard Deviation 4.88
-.52 Change in T-Score
Standard Deviation 4.37
1.74 Change in T-Score
Standard Deviation 5.09
.52 Change in T-Score
Standard Deviation 5.43
-1.81 Change in T-Score
Standard Deviation 7.43
-.81 Change in T-Score
Standard Deviation 8.11
-4.11 Change in T-Score
Standard Deviation 8.80

SECONDARY outcome

Timeframe: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire (Zarit, Reever \& Bach-Peterson, 1980). The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The total score range is 0 to 88. Increasing scores indicate increasing burden. Scores were measured at baseline and at 1 month post-intervention and a change score was computed for each participant. These change scores are averaged to produce the by-condition mean change in burden score. Positive results indicate an increase in burden, and negative results indicate a decrease in burden.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in Zarit Caregiver Burden Score
-.44 Change in Burden Score
Standard Deviation 12.62
-3.35 Change in Burden Score
Standard Deviation 7.93
0 Change in Burden Score
Standard Deviation 14.35
-2.59 Change in Burden Score
Standard Deviation 8.45
-.07 Change in Burden Score
Standard Deviation 7.69
-3.21 Change in Burden Score
Standard Deviation 11.22
-9.6 Change in Burden Score
Standard Deviation 12.05
-6.69 Change in Burden Score
Standard Deviation 14.97

SECONDARY outcome

Timeframe: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. We deployed PROMIS Fatigue Form 7a, a seven item likert scale panel ranging from 1=never to 5=always. Scores range from 7-35. Higher scores indicate more fatigue. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in PROMIS Fatigue Score
.08 Change in T-Score
Standard Error 5.22
-4.12 Change in T-Score
Standard Error 5.88
3.33 Change in T-Score
Standard Error 9.9
1.36 Change in T-Score
Standard Error 5.97
-2.58 Change in T-Score
Standard Error 6.29
-2.9 Change in T-Score
Standard Error 8.86
-.36 Change in T-Score
Standard Error 7.43
-4.26 Change in T-Score
Standard Error 11.72

SECONDARY outcome

Timeframe: 1 months post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

the PROMIS General Self-Efficacy - Short Form is a four item panel which measures confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The four items are 1-5 Likert scales, 1=never, 5=always. Minimum score is a 4 and maximum is a 20. Raw Scores are converted to T scores with mean 50 and SD 10 per the PROMIS scoring manual. Higher score=greater self efficacy.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in PROMIS Short Form General Self Efficacy T Score
-1.32 change in T-Score
Standard Deviation 6.13
.68 change in T-Score
Standard Deviation 10.14
.06 change in T-Score
Standard Deviation 7.57
-2.14 change in T-Score
Standard Deviation 5
-.57 change in T-Score
Standard Deviation 5.24
1.22 change in T-Score
Standard Deviation 11.63
.55 change in T-Score
Standard Deviation 8.29
1.59 change in T-Score
Standard Deviation 7.74

SECONDARY outcome

Timeframe: Baseline Measure

Population: All individuals who received and completed the baseline assessment are included in the analysis population (N=131).

PROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confident relationships. The short form 6a deployed here is a 6 item likert scale panel, which assesses responses as 1=never and 5=always in response to item statements. Minimum score is a 6 and maximum is a 30. Higher scores indicate greater feelings of emotional support. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
PROMIS Short Form Emotional Support T Score at Baseline
52.00 T-Score
Standard Deviation 9.44
52.26 T-Score
Standard Deviation 10.19
51.68 T-Score
Standard Deviation 9.37
52.38 T-Score
Standard Deviation 6.62
50.42 T-Score
Standard Deviation 9.28
54.93 T-Score
Standard Deviation 9.35
52.23 T-Score
Standard Deviation 9.77
50.58 T-Score
Standard Deviation 8.03

SECONDARY outcome

Timeframe: 1 months post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

The PROMIS adult Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"). Short form 8a is deployed here. This is an 8 item likert scale panel, with responses rated 1=never and 5=always. Scores range from 8 to 40. Higher scores indicate greater satisfaction with social roles and activities. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in PROMIS Satisfaction With Social Roles/Activities Score
-1.45 Change in T Score
Standard Deviation 5.29
-.09 Change in T Score
Standard Deviation 4.42
-.92 Change in T Score
Standard Deviation 5.51
-.55 Change in T Score
Standard Deviation 2.82
.9 Change in T Score
Standard Deviation 4.7
2.17 Change in T Score
Standard Deviation 5.58
.49 Change in T Score
Standard Deviation 5.55
.79 Change in T Score
Standard Deviation 5.26

SECONDARY outcome

Timeframe: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

TBI-CareQOL is a set of self-report measures within the Neuro-QoL™ measurement system that assesses the health-related quality of life (HRQOL) of caregivers of adults with traumatic brain injury (TBI). Among these is the Caregiver specific anxiety measure. This is a six item likert panel with responses rated 1=never and 5=always, for a combined score range of 6-30. Higher scores indicate greater levels of anxiety. Raw scores were rescaled per the Neuro-QoL scoring manual into T-Scores with a mean of 50 and an SD of 10. Difference between T-score at baseline and 1-month was computed for each participant to produce a change score, and these change scores are averaged to produce per condition means.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in Neuro-QoL Caregiver Specific Anxiety Score
.27 change in T-Score
Standard Deviation 7.71
-.37 change in T-Score
Standard Deviation 7.17
.58 change in T-Score
Standard Deviation 6.69
-.39 change in T-Score
Standard Deviation 4.33
-.31 change in T-Score
Standard Deviation 4.12
-2.21 change in T-Score
Standard Deviation 7.09
-2.48 change in T-Score
Standard Deviation 6.36
-1.4 change in T-Score
Standard Deviation 5.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post-baseline

Population: 131 participants were randomized from a total 133 consented- 2 did not complete pre-randomization activities. Here we were interested in the raw number of recruited participants retained regardless of intervention received, thus all participants were considered in the analysis and group segmentation would be inappropriate for the calculation.

Percentage- numerator=# of participants who completed 3 month post-baseline assessment, denominator=# of participants randomized to a condition.

Outcome measures

Outcome measures
Measure
Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=131 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Participant Retention Rate at 3 Months Post-baseline
124 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks post-intervention

Population: 128 participants of 131 randomized completed the 2 weeks post-intervention assessment.

Measuring the feasibility of the intervention by measuring the usability of the intervention as measured by the System Usability Scale (SUS), a 10-item measure of usability. SUS is a 10-item likert panel, with scores ranging from 1-5. Scores are tabulated by converting raw scores by subtracting 1 from each raw score and then summing per the scoring manual: summed score=2.5\*(20+(sum of odd numbered questions)-(sum of even number questions)). The minimum and maximum values are thus 50 and 100. Higher scores indicate greater usability.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
System Usability Scale Score
65 score on a scale
Standard Deviation 12
73 score on a scale
Standard Deviation 14
71 score on a scale
Standard Deviation 13
63 score on a scale
Standard Deviation 17
68 score on a scale
Standard Deviation 16
68 score on a scale
Standard Deviation 16
68 score on a scale
Standard Deviation 17
67 score on a scale
Standard Deviation 19

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks post-intervention

Population: 128 of 131 randomized participants completed the post-intervention assessment.

The USE Acceptability score measures the acceptability of the intervention, employing an 8-item panel of 1-7 Likert scale questions, with a 0 option for "not applicable". Raw score is converted to 0-100 score as follows: 2.040163\*(summed raw scores - 8). Higher scores indicate greater acceptability.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
USE Acceptability Score
74 score on a scale
Standard Deviation 12
65 score on a scale
Standard Deviation 23
80 score on a scale
Standard Deviation 12
71 score on a scale
Standard Deviation 19
78 score on a scale
Standard Deviation 11
73 score on a scale
Standard Deviation 22
74 score on a scale
Standard Deviation 20
70 score on a scale
Standard Deviation 67

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks post-baseline

Measuring the feasibility of the intervention by assessing completion of negotiation training exercises.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Exercise Completion Rate
16 Participants
17 Participants
15 Participants
17 Participants
15 Participants
16 Participants
16 Participants
16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post-baseline

Population: All 125 participants who completed both the baseline and 1-month post-intervention assessments are included in the analysis.

The Dutch Test for Conflict Handling measures aspects of conflict resolution pertaining to the negotiator. The DUTCH measures conflict handling in five domains: avoiding, forcing, yielding, problem solving, and compromising. Each domain is measured independently using panels of four 1-5 likert scale questions each. Domain scores thus range from 5-20, converted to 0-100 with the following formula: 6.25\*(domain score-1). Intra-participant change is measured for each subdomain between baseline and 1 month and generalized to produce mean change per domain. Higher scores per domain indicate more intense conflict handling behavior in the given domain- lower scores indicate less intensity.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in DUTCH Conflict Handling Scores
Change in Compromising Score
3.52 Change in Domain Score (out of 100)
Standard Deviation 18.25
3.31 Change in Domain Score (out of 100)
Standard Deviation 13.82
2.08 Change in Domain Score (out of 100)
Standard Deviation 19.72
-2.94 Change in Domain Score (out of 100)
Standard Deviation 12.13
2.08 Change in Domain Score (out of 100)
Standard Deviation 13.71
6.25 Change in Domain Score (out of 100)
Standard Deviation 17.68
2.92 Change in Domain Score (out of 100)
Standard Deviation 16.17
1.56 Change in Domain Score (out of 100)
Standard Deviation 20.22
Change in DUTCH Conflict Handling Scores
Change in Forcing Score
-18.36 Change in Domain Score (out of 100)
Standard Deviation 28.09
-3.68 Change in Domain Score (out of 100)
Standard Deviation 15.63
-9.17 Change in Domain Score (out of 100)
Standard Deviation 14.92
-3.31 Change in Domain Score (out of 100)
Standard Deviation 14.34
-7.5 Change in Domain Score (out of 100)
Standard Deviation 13.19
-9.38 Change in Domain Score (out of 100)
Standard Deviation 14.66
-2.5 Change in Domain Score (out of 100)
Standard Deviation 18.57
-1.56 Change in Domain Score (out of 100)
Standard Deviation 23.11
Change in DUTCH Conflict Handling Scores
Change in Problem Solving Score
0 Change in Domain Score (out of 100)
Standard Deviation 16.93
4.04 Change in Domain Score (out of 100)
Standard Deviation 17.25
1.67 Change in Domain Score (out of 100)
Standard Deviation 14.46
-2.57 Change in Domain Score (out of 100)
Standard Deviation 9.13
-2.08 Change in Domain Score (out of 100)
Standard Deviation 13.08
8.48 Change in Domain Score (out of 100)
Standard Deviation 13.56
-6.67 Change in Domain Score (out of 100)
Standard Deviation 17.43
-4.3 Change in Domain Score (out of 100)
Standard Deviation 19.06
Change in DUTCH Conflict Handling Scores
Change in Yielding Score
-1.95 Change in Domain Score (out of 100)
Standard Deviation 10.88
3.68 Change in Domain Score (out of 100)
Standard Deviation 11.49
2.5 Change in Domain Score (out of 100)
Standard Deviation 12.90
1.1 Change in Domain Score (out of 100)
Standard Deviation 11.32
-5.42 Change in Domain Score (out of 100)
Standard Deviation 13.12
-1.79 Change in Domain Score (out of 100)
Standard Deviation 13.74
-3.33 Change in Domain Score (out of 100)
Standard Deviation 14.54
-4.3 Change in Domain Score (out of 100)
Standard Deviation 9.87
Change in DUTCH Conflict Handling Scores
Change in Avoiding Score
-9.38 Change in Domain Score (out of 100)
Standard Deviation 13.31
-.37 Change in Domain Score (out of 100)
Standard Deviation 13.34
-.83 Change in Domain Score (out of 100)
Standard Deviation 14.73
-.74 Change in Domain Score (out of 100)
Standard Deviation 14.3
11.25 Change in Domain Score (out of 100)
Standard Deviation 19.51
.89 Change in Domain Score (out of 100)
Standard Deviation 15.08
-1.25 Change in Domain Score (out of 100)
Standard Deviation 17.55
-2.34 Change in Domain Score (out of 100)
Standard Deviation 19.48

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 months post-baseline

Population: All Participants who completed the 1 month post-intervention assessment are included.

We deployed a panel of 15 questions measuring participant knowledge of negotiation techniques. The panel measures knowledge in three subdomains (identification of interests, rights, and power statements) and can also be measured in aggregate to assess knowledge across the three subdomains. Participants receive 1 point for each correct answer. All Scores, including subdomain scores, are converted to a 0/100 measure. Intraparticipant change is assessed between baseline and 1 month post-intervention. Dependent Sample T-Tests were performed on the change scores from baseline-1 month.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change in Negotiation Knowledge Scores
Change in Interests score
9.38 Change in Score Baseline-1 Month
Standard Deviation 21.05
7.84 Change in Score Baseline-1 Month
Standard Deviation 17.79
4.44 Change in Score Baseline-1 Month
Standard Deviation 17.21
4.9 Change in Score Baseline-1 Month
Standard Deviation 11.43
6.67 Change in Score Baseline-1 Month
Standard Deviation 12.28
1.19 Change in Score Baseline-1 Month
Standard Deviation 10.26
-1.11 Change in Score Baseline-1 Month
Standard Deviation 27.79
5.21 Change in Score Baseline-1 Month
Standard Deviation 15.77
Change in Negotiation Knowledge Scores
Change in Rights Score
7.5 Change in Score Baseline-1 Month
Standard Deviation 21.76
4.71 Change in Score Baseline-1 Month
Standard Deviation 16.63
2.67 Change in Score Baseline-1 Month
Standard Deviation 16.68
2.35 Change in Score Baseline-1 Month
Standard Deviation 28.18
10.67 Change in Score Baseline-1 Month
Standard Deviation 31.95
-4.29 Change in Score Baseline-1 Month
Standard Deviation 19.5
5.33 Change in Score Baseline-1 Month
Standard Deviation 22
-3.75 Change in Score Baseline-1 Month
Standard Deviation 18.21
Change in Negotiation Knowledge Scores
Change in total score
8.33 Change in Score Baseline-1 Month
Standard Deviation 14.91
4.71 Change in Score Baseline-1 Month
Standard Deviation 9.65
3.11 Change in Score Baseline-1 Month
Standard Deviation 12.82
2.35 Change in Score Baseline-1 Month
Standard Deviation 13.11
6.22 Change in Score Baseline-1 Month
Standard Deviation 11.94
-1.9 Change in Score Baseline-1 Month
Standard Deviation 11.23
.89 Change in Score Baseline-1 Month
Standard Deviation 19.82
.42 Change in Score Baseline-1 Month
Standard Deviation 9.57
Change in Negotiation Knowledge Scores
Change in Power Score
7.81 Change in Score Baseline-1 Month
Standard Deviation 17.6
0 Change in Score Baseline-1 Month
Standard Deviation 17.68
1.67 Change in Score Baseline-1 Month
Standard Deviation 25.82
-1.47 Change in Score Baseline-1 Month
Standard Deviation 20.67
0 Change in Score Baseline-1 Month
Standard Deviation 23.15
-3.57 Change in Score Baseline-1 Month
Standard Deviation 13.36
-1.67 Change in Score Baseline-1 Month
Standard Deviation 25.82
-1.56 Change in Score Baseline-1 Month
Standard Deviation 11.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post-baseline

Population: 125 participants out of 131 randomized had data available at one month post-intervention. Of those, only 85 were deployed the website utilization question.

We deployed a survey panel of 5 yes/no questions to participants asking them about utilization of negotiation techniques in the month following the intervention. Result rates are out of 100%.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Utilization Rates
In the past month, have you experienced any conflicts related to the care of your older adult? · No
6 Participants
12 Participants
8 Participants
5 Participants
8 Participants
7 Participants
5 Participants
7 Participants
Utilization Rates
In the past month, have you experienced any conflicts related to the care of your older adult? · Yes
10 Participants
5 Participants
7 Participants
12 Participants
7 Participants
7 Participants
10 Participants
9 Participants
Utilization Rates
In the past month, have you used anything you learned from the negotiation training activities? · No
8 Participants
10 Participants
8 Participants
13 Participants
6 Participants
6 Participants
9 Participants
13 Participants
Utilization Rates
Are there other parts of your life where you used negotiation skills gained during this study? · No
8 Participants
10 Participants
8 Participants
13 Participants
6 Participants
6 Participants
9 Participants
13 Participants
Utilization Rates
In the past month, have you negotiated anything related to the care of your older adult? · Yes
9 Participants
6 Participants
10 Participants
9 Participants
6 Participants
9 Participants
9 Participants
7 Participants
Utilization Rates
In the past month, have you visited NegotiAge.com? · No
4 Participants
5 Participants
5 Participants
5 Participants
4 Participants
7 Participants
7 Participants
4 Participants
Utilization Rates
In the past month, have you visited NegotiAge.com? · Yes
7 Participants
7 Participants
4 Participants
7 Participants
6 Participants
3 Participants
3 Participants
7 Participants
Utilization Rates
In the past month, have you used anything you learned from the negotiation training activities? · Yes
8 Participants
7 Participants
7 Participants
4 Participants
9 Participants
8 Participants
6 Participants
3 Participants
Utilization Rates
Are there other parts of your life where you used negotiation skills gained during this study? · Yes
8 Participants
7 Participants
7 Participants
4 Participants
9 Participants
8 Participants
6 Participants
3 Participants
Utilization Rates
In the past month, have you negotiated anything related to the care of your older adult? · No
7 Participants
11 Participants
5 Participants
8 Participants
9 Participants
5 Participants
6 Participants
9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post-baseline

Population: All participants with data available at 1 month post-intervention were included in the analysis.

The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores are evaluated out of 50. The ten item scales thus have score ranges from 10-50. Higher scores in a single domain indicate greater perception of that type of affect. So, higher positive affect scores=greater positive affect, and higher negative affect scores=higher negative affect. Positive change on either scale indicates an increase in that domain, and negative change on either scale indicates a decrease in that domain.

Outcome measures

Outcome measures
Measure
Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister
n=17 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
Sister/OA
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Sister/Physician
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Universal Only
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
Older Adult
n=14 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
Physician
n=15 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
Sister/Physician/OA
n=16 Participants
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
Change In Positive and Negative Affect Schedule Scores
Positive Affect Score
.75 Change in Score
Standard Deviation 5.72
.76 Change in Score
Standard Deviation 3.98
.2 Change in Score
Standard Deviation 4.89
.47 Change in Score
Standard Deviation 4.35
-.53 Change in Score
Standard Deviation 2.7
1.21 Change in Score
Standard Deviation 4.69
0 Change in Score
Standard Deviation 5.15
-.13 Change in Score
Standard Deviation 7.11
Change In Positive and Negative Affect Schedule Scores
Negative Affect Score
-2.19 Change in Score
Standard Deviation 7.13
-2.12 Change in Score
Standard Deviation 5.05
-1.2 Change in Score
Standard Deviation 4.75
-1.76 Change in Score
Standard Deviation 6.19
-.2 Change in Score
Standard Deviation 4.06
-2.21 Change in Score
Standard Deviation 5.15
-2.67 Change in Score
Standard Deviation 5.74
-4.19 Change in Score
Standard Deviation 7.26

Adverse Events

Condition 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 6

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 7

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Condition 8

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

Vanessa Ramirez-Zohfeld

Northwestern University- Feinberg School of Medicine- Division of Geriatrics

Phone: +1 312 503 3916

Results disclosure agreements

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