Clinical Trials Directory

Trials / Completed

CompletedNCT02568475

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

Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
192 (actual)
Sponsor
Florida Atlantic University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALProvision 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.

Timeline

Start date
2012-10-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2015-10-06
Last updated
2020-08-31
Results posted
2020-08-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02568475. Inclusion in this directory is not an endorsement.