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

• Sponsor: Florida Atlantic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02568475
• Collaborator: (none)
• Enrollment: 192
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of interest related to development of decision support tools that bring patients, families and clinicians together to decide, in this instance, whether or not transfer from the nursing home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to develop an evidence-based decision aid addressing potentially avoidable transfers of residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this decision aid in terms of acceptability to residents and families and its effect on the quality of transfer decisions.

The primary hypotheses to be tested are:

Hypothesis 1: Resident and family members in the intervention group will report greater preparation for decision making and less decisional conflict than those in the no treatment control group.

Hypothesis 2: Residents and family members in the intervention group will demonstrate increased knowledge related to acute care transfer and less preference for acute care transfer than those in the no treatment control group.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease; Acute Disease	Behavioral: Provision of "Go to the Hospital or Stay Here?"	N/A

Detailed Description

Project Summary: The goal of this project is to develop (Phase I) and test (Phase II) a new Transfer Decision aid that will better prepare nursing home (NH) residents and their families to participate in decisions to transfer the resident to an acute care facility or remain in the NH for treatment.

Objectives: The specific aim of this study is to evaluate the decision aid, "Go to the Hospital or Stay Here?" in terms of acceptability to residents and families and its effect on decision making and transfer decisions by residents and families.

Study Design: A mixed methods design was used to address the study aims. In Phase I (not submitted to ClinicalTrials.gov), interviews of a diverse sample of NH residents, their family members, primary care providers, nurses and social workers in the NH were conducted and the results were used to create a Transfer Decision aid to be pilot tested in Phase II for its effect on decision making and transfer decisions.

Phase II involves a pretest, intervention for the half randomly selected to receive it, 14 day posttest and 90 day follow-up.

Study Population: Staff of 15 participating South Florida nursing homes (NHs) were asked to recommend residents and family members of residents who could participate in the study. Residents were tested for ability to provide consent using the Mini-Cog prior to enrollment.

General Analytic Strategy: Multiple linear regression (MLR) will be used to analyze the variance when predicting the primary and secondary outcome variables, preparation for decision making, decisional conflict, knowledge and number of transfers (McNeil, Newman & Kellee, 1996; Pedhazur & Schmelking, 1991). For qualitative data, Phase II interviews are transcribed and the transcriptions reviewed for accuracy. Responses were de-identified (names, gender and ethnic identity information removed). A framework for descriptive (labeling and categorizing), interpretive (based on underlying meaning) and pattern (thematic) codes was developed. Intercoder reliability was calculated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision aid Provision of "Go to the Hospital or Stay Here?"	Behavioral: 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.; Other Names: Transfer Decision Guide
No Intervention: No decision aid Does not receive the decision aid.

Outcome Measures

Primary Outcome Measures

1. Preparation for Decision Making [Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)]

   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.

2. Decisional Conflict Scale [Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only]

   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

Secondary Outcome Measures

1. Knowledge Test [Pretest (baseline) and Post test (2-3 weeks after pretest)]

   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

2. Treatment Preference/Decisional Conflict Scale [Post test (2-3 weeks after pretest)]

   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.

3. 30 Day Hospital Readmission [Length of stay ≤30 days at Post test]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult nursing home resident and/or family member or identified significant other of a nursing home resident. Cognitively unimpaired individuals. Long or short term residents of nursing home or rehabilitation center.

Exclusion Criteria:

• Dementia as indicated by score on Mini-Cog. Inability to respond to questions due to physical disability or illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Atlantic University, Christine E. Lynn College of Nursing	Boca Raton	Florida	United States	33431

Sponsors and Collaborators

• Florida Atlantic University

Investigators

• Principal Investigator: Ruth M. Tappen, EdD, RN, FAAN, Christine E. Lynn College of Nursing, Florida Atlantic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruth Tappen, Christine E. Lynn Eminent Scholar and Professor, Florida Atlantic University
• ClinicalTrials.gov Identifier: NCT02568475
• Other Study ID Numbers: 343268; 1IP2PI000281-01
• First Posted: Oct 6, 2015
• Last Update Posted: Aug 31, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Ruth Tappen, Christine E. Lynn Eminent Scholar and Professor, Florida Atlantic University: nursing home residents, decision aid, acute care transfers
• Additional relevant MeSH terms: Chronic Disease; Acute Disease

Study Results

Participant Flow

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Period Title: Overall Study
STARTED	97	95
Post-test	85	82
COMPLETED	46	52
NOT COMPLETED	51	43

Baseline Characteristics

Arm/Group Title	Decision Aid	No Decision Aid	Total
Arm/Group Description	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.	Does not receive the decision aid.	Total of all reporting groups
Overall Participants	97	95	192
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 19.6%	12 12.6%	31 16.1%
>=65 years	78 80.4%	83 87.4%	161 83.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.69 (12.72)	79.3 (13.94)	78.05 (13.38)
Sex: Female, Male (Count of Participants)
Female	66 68%	63 66.3%	129 67.2%
Male	31 32%	32 33.7%	63 32.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 2.1%	5 5.3%	7 3.6%
Not Hispanic or Latino	93 95.9%	86 90.5%	179 93.2%
Unknown or Not Reported	2 2.1%	4 4.2%	6 3.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 2.1%	0 0%	2 1%
Asian	3 3.1%	0 0%	3 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 5.2%	20 21.1%	25 13%
White	87 89.7%	74 77.9%	161 83.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1.1%	1 0.5%
Region of Enrollment (Count of Participants)
Southeast Florida	97 100%	95 100%	192 100%
Elsewhere	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Preparation for Decision Making
Description	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.
Time Frame	Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Measure Participants	39	0
Post test	39.59 (9.113)
3 month follow-up	36.00 (10.084)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid
	Comments
	Type of Statistical Test	Equivalence
	Comments	Continuous scale: score compares results before and after intervention without a cut parameter.
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.59
	Confidence Interval	(2-Sided) 95%; 0.059 to 7.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.74
	Estimation Comments

2. Primary Outcome

Title	Decisional Conflict Scale
Description	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
Time Frame	Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Measure Participants	84	78
Pretest	13.11 (12.01)	NA (NA)
Post test	9.39 (9.98)	15.73 (14.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decision Aid, No Decision Aid
	Comments
	Type of Statistical Test	Other
	Comments	This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.78
	Confidence Interval	(2-Sided) 95%; 2.9 to 10.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Knowledge Test
Description	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
Time Frame	Pretest (baseline) and Post test (2-3 weeks after pretest)

Outcome Measure Data

Analysis Population Description

Nursing Home Residents and Family Members

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Measure Participants	82	79
Pretest	15.63 (2.69)	15.19 (2.64)
Post test	17.38 (2.86)	15.80 (2.56)

4. Secondary Outcome

Title	Treatment Preference/Decisional Conflict Scale
Description	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.
Time Frame	Post test (2-3 weeks after pretest)

Outcome Measure Data

Analysis Population Description

Nursing Home Residents and Family Members

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Measure Participants	84	78
Prefer Hospital	17 17.5%	23 24.2%
Prefer Nursing Home	17 17.5%	6 6.3%
No Response	50 51.5%	49 51.6%

5. Secondary Outcome

Title	30 Day Hospital Readmission
Description	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.
Time Frame	Length of stay ≤30 days at Post test

Outcome Measure Data

Analysis Population Description

Nursing Home Residents and Family Members

Arm/Group Title	Decision Aid	No Decision Aid
Arm/Group Description	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.	Does not receive the decision aid.
Measure Participants	87	83
Count of Participants [Participants]	8 8.2%	5 5.3%

Adverse Events

Time Frame	6-8 months
Adverse Event Reporting Description	Serious adverse events reported to IRB
Arm/Group Title	Decision Aid		No Decision Aid
Arm/Group Description	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.		Does not receive the decision aid.
All Cause Mortality
	Decision Aid		No Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/95 (0%)
Serious Adverse Events
	Decision Aid		No Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/95 (0%)
Other (Not Including Serious) Adverse Events
	Decision Aid		No Decision Aid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/95 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.