Trial Outcomes & Findings for Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions (NCT NCT02568475)

Last Updated: 2020-08-31

Results Overview

Range of possible raw scores: 10 - 50. Items can be summed and scored (sum the 10 items and divide by 10). There are no subscales. A higher score is positive indicating perception of being better prepared to make the decision identified when test is administered.

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)

Results posted on

2020-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Decision Aid Provision of "Go to the Hospital or Stay Here?" Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid Does not receive the decision aid.
Overall Study STARTED	97	95
Overall Study Post-test	85	82
Overall Study COMPLETED	46	52
Overall Study NOT COMPLETED	51	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Decision Aid Provision of "Go to the Hospital or Stay Here?" Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid Does not receive the decision aid.
Overall Study Lost to Follow-up	40	39
Overall Study Withdrawal by Subject	2	0
Overall Study Discharged home	4	4
Overall Study Short-term: Discharge location unknown	4	0
Overall Study Transferred to another facility	1	0

Baseline Characteristics

Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid n=97 Participants Provision of "Go to the Hospital or Stay Here?" Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid n=95 Participants Does not receive the decision aid.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	12 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical >=65 years	78 Participants n=93 Participants	83 Participants n=4 Participants	161 Participants n=27 Participants
Age, Continuous	76.69 years STANDARD_DEVIATION 12.72 • n=93 Participants	79.3 years STANDARD_DEVIATION 13.94 • n=4 Participants	78.05 years STANDARD_DEVIATION 13.38 • n=27 Participants
Sex: Female, Male Female	66 Participants n=93 Participants	63 Participants n=4 Participants	129 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=93 Participants	86 Participants n=4 Participants	179 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	20 Participants n=4 Participants	25 Participants n=27 Participants
Race (NIH/OMB) White	87 Participants n=93 Participants	74 Participants n=4 Participants	161 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States · Southeast Florida	97 Participants n=93 Participants	95 Participants n=4 Participants	192 Participants n=27 Participants
Region of Enrollment United States · Elsewhere	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)

Population: This analysis only included those that received the Decision Aid intervention and were collected at the end of the intervention (Time Point 2) and with a 3-month follow-up. Only 39 participants were still residents in the nursing homes during the 3-month follow-up.

Outcome measures

Outcome measures
Measure	Decision Aid n=39 Participants Received and Discussed the Decision Aid Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid Does not receive the decision aid.
Preparation for Decision Making Post test	39.59 score on a scale Standard Deviation 9.113	—
Preparation for Decision Making 3 month follow-up	36.00 score on a scale Standard Deviation 10.084	—

PRIMARY outcome

Timeframe: Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

Population: Nursing Home Residents and Family Members. Only data for the Decision Aid group was collected for this outcome. The No Decision Aid Group, didn't receive the intervention and no data was analyzed before pre-test, therefore no data was collected. However, the score was analyzed in the No Decision Aid group (N=78) at the post-test time.

Scale Range of possible raw scores: 0 - 64. A lower score indicates less decisional conflict related to making the identified decision. Decisional conflict is a state of uncertainty about a course of action. Decision supporting interventions are thought to be effective in

Outcome measures

Outcome measures
Measure	Decision Aid n=84 Participants Received and Discussed the Decision Aid Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid n=78 Participants Does not receive the decision aid.
Decisional Conflict Scale Pretest	13.11 score on a scale Standard Deviation 12.01	NA score on a scale Standard Deviation NA The No Decision Aid group did not do the Decision Aid during Pretest
Decisional Conflict Scale Post test	9.39 score on a scale Standard Deviation 9.98	15.73 score on a scale Standard Deviation 14.68

SECONDARY outcome

Timeframe: Pretest (baseline) and Post test (2-3 weeks after pretest)

Population: Nursing Home Residents and Family Members

Decision Aid Quiz Investigator Developed: True/False Test of Knowledge based upon information in the Decision Aid. Scale Range: 0 - 22. Total score is the number of questions answered correct. A higher score indicates greater number of responses are correct. Items are scored as 0 = incorrect; 1 = correct. Criteria used to assess this measure: Items based upon concept mapping of the Decision Aid Reviewed by a panel of experts prior to administration

Outcome measures

Outcome measures
Measure	Decision Aid n=82 Participants Received and Discussed the Decision Aid Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid n=79 Participants Does not receive the decision aid.
Knowledge Test Pretest	15.63 score on a scale Standard Deviation 2.69	15.19 score on a scale Standard Deviation 2.64
Knowledge Test Post test	17.38 score on a scale Standard Deviation 2.86	15.80 score on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Post test (2-3 weeks after pretest)

Population: Nursing Home Residents and Family Members

Treatment Site Option Preference Administered prior to the Decisional Conflict Scale, this single item was used to ask participants if they preferred treatment in the hospital or nursing home or if the preference depended upon the seriousness of their condition (three choices). This is nominal level data. The administration of the item precedes administration of the Decisional Conflict Scale (DCS) described previously. Standard administration of the Decision Conflict Scale includes this item but it is not part of the DCS score.

Outcome measures

Outcome measures
Measure	Decision Aid n=84 Participants Received and Discussed the Decision Aid Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid n=78 Participants Does not receive the decision aid.
Treatment Preference/Decisional Conflict Scale Prefer Hospital	17 participants	23 participants
Treatment Preference/Decisional Conflict Scale Prefer Nursing Home	17 participants	6 participants
Treatment Preference/Decisional Conflict Scale No Response	50 participants	49 participants

SECONDARY outcome

Timeframe: Length of stay ≤30 days at Post test

Population: Nursing Home Residents and Family Members

Report of all hospitalizations from facility staff or participants Hospital Transfers Occurring During Study Period, i.e., number of resident participants who were hospitalized from pretest to posttest and by end of 3 month follow-up period.

Outcome measures

Outcome measures
Measure	Decision Aid n=87 Participants Received and Discussed the Decision Aid Provision of "Go to the Hospital or Stay Here?": Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.	No Decision Aid n=83 Participants Does not receive the decision aid.
30 Day Hospital Readmission	8 Participants	5 Participants

Adverse Events

Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Decision Aid

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

Ruth M. Tappen, Principal Investigator

Florida Atlantic University

Phone: 561-297-2613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place