Chronic Disease Clinical Trial
Official title:
Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid
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.
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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