Clinical trial NCT02568475: Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions
Official title: Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Acute Disease
Keywords: nursing home residents, decision aid, acute care transfers
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Preparation for Decision Making
timeFrame: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)
measure: Decisional Conflict Scale
timeFrame: Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only
Secondary outcomes:
measure: Knowledge Test
timeFrame: Pretest (baseline) and Post test (2-3 weeks after pretest)
measure: Treatment Preference/Decisional Conflict Scale
timeFrame: Post test (2-3 weeks after pretest)
measure: 30 Day Hospital Readmission
timeFrame: Length of stay ≤30 days at Post test
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Florida Atlantic University, Christine E. Lynn College of Nursing
state: Florida
Study officials:
affiliation: Christine E. Lynn College of Nursing, Florida Atlantic University
name: Ruth M. Tappen, EdD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tappen RM, Worch SM, Elkins D, Hain DJ, Moffa CM, Sullivan G. Remaining in the nursing home versus transfer to acute care: resident, family, and staff preferences. J Gerontol Nurs. 2014 Oct;40(10):48-57. doi: 10.3928/00989134-20140807-01.