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Trial Outcomes & Findings for Shared Decision Making to Improve Palliative Care in the Nursing Home (NCT NCT02917603)

NCT ID: NCT02917603

Last Updated: 2021-01-20

Results Overview

9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

30 days

Results posted on

2021-01-20

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention
These family members and residents will use web conferencing technology to attend their quarterly care conferences Web Conferencing: Individuals will communicate with the nursing home team via web conferencing during quarterly care conference
Control
These family and residents will receive usual care
Overall Study
STARTED
20
20
Overall Study
COMPLETED
19
16
Overall Study
NOT COMPLETED
1
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shared Decision Making to Improve Palliative Care in the Nursing Home

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=20 Participants
These family members and residents will use web conferencing technology to attend their quarterly care conferences
Control
n=20 Participants
These family and residents will receive usual care
Total
n=40 Participants
Total of all reporting groups
Age, Customized
Mean Age at consent
55.7 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
57.2 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
56.4 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
19 Participants
n=7 Participants
39 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 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
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
20 Participants
n=5 Participants
19 Participants
n=7 Participants
39 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants
Anxiety (GAD-7)
2.10 Score on a scale
STANDARD_DEVIATION 3.34 • n=5 Participants
2.10 Score on a scale
STANDARD_DEVIATION 2.86 • n=7 Participants
2.10 Score on a scale
STANDARD_DEVIATION 3.07 • n=5 Participants
Depression (PHQ-9)
1.50 units on a scale
STANDARD_DEVIATION 1.47 • n=5 Participants
2.55 units on a scale
STANDARD_DEVIATION 3.63 • n=7 Participants
2.03 units on a scale
STANDARD_DEVIATION 2.79 • n=5 Participants
Burden (Zarit)
2.45 score on a scale
STANDARD_DEVIATION 2.37 • n=5 Participants
3.7 score on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
3.08 score on a scale
STANDARD_DEVIATION 3.08 • n=5 Participants
Caregiver Quality of Life (CQLI-R)
33.75 units on a scale
STANDARD_DEVIATION 5.14 • n=5 Participants
30.95 units on a scale
STANDARD_DEVIATION 7.04 • n=7 Participants
32.35 units on a scale
STANDARD_DEVIATION 6.25 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.

Outcome measures

Outcome measures
Measure
Intervention
n=20 Participants
These family members and residents will use web conferencing technology to attend their quarterly care conferences
Control
n=20 Participants
These family and residents will receive usual care
Difference in Mean Patient Health Questionaire 9 Score From Baseline
.74 units on a scale
Standard Deviation 1.19
3.38 units on a scale
Standard Deviation 3.5

SECONDARY outcome

Timeframe: 30 days

Family members will report which of their responsibilities are perceived as burdensome. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Total score computed with an average score response.

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
These family members and residents will use web conferencing technology to attend their quarterly care conferences
Control
n=16 Participants
These family and residents will receive usual care
Zarit Burden Interview
3.16 units on a scale
Standard Deviation 2.63
4.25 units on a scale
Standard Deviation 4.93

SECONDARY outcome

Timeframe: 30 days

7 questions that measure family member anxiety. It has 7 items and is scored 0-21 with a higher number representing greater anxiety. A total score is computed.

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
These family members and residents will use web conferencing technology to attend their quarterly care conferences
Control
n=16 Participants
These family and residents will receive usual care
Generalized Anxiety- 7
.63 score on a scale
Standard Deviation .96
2.06 score on a scale
Standard Deviation 2.72

SECONDARY outcome

Timeframe: 30 days

4 questions pertaining to family quality of life. There are 4 items each scored 0-9 with a total score of 0 to 36 and higher scores representing poorer quality of life.

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
These family members and residents will use web conferencing technology to attend their quarterly care conferences
Control
n=16 Participants
These family and residents will receive usual care
Caregiver Quality of Life
33.79 units on a scale
Standard Deviation 4.21
32.06 units on a scale
Standard Deviation 7.89

Adverse Events

Intervention

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

Control

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

Debra Parker Oliver; PI

UMissouri

Phone: 573-356-6719

Results disclosure agreements

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