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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568475
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Ruth Tappen, Florida Atlantic University

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?" Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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 Name: Transfer Decision Guide

No Intervention: No decision aid
Does not receive the decision aid.



Primary Outcome Measures :
  1. Preparation for Decision Making [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568475


Locations
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United States, Florida
Florida Atlantic University, Christine E. Lynn College of Nursing
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Florida Atlantic University
Investigators
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Principal Investigator: Ruth M. Tappen, EdD, RN, FAAN Christine E. Lynn College of Nursing, Florida Atlantic University
Publications of Results:
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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 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: October 6, 2015    Key Record Dates
Results First Posted: August 31, 2020
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by Ruth Tappen, Florida Atlantic University:
nursing home residents, decision aid, acute care transfers
Additional relevant MeSH terms:
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Chronic Disease
Acute Disease
Disease Attributes
Pathologic Processes