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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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
Sponsor: Florida Atlantic University

Current Primary Outcome:

• Preparation for Decision Making [ Time Frame: 2 - 3 weeks Post-Intervention ]
  10 item scale designed to evaluate resident and family perceptions of how useful a decision aid is in preparing to communicate with the practitioner during a consultation visit and to make a health care decision.
• Decisional Conflict Scale [ Time Frame: 2 - 3 weeks Post-Intervention ]
  Measures uncertainty about the decision to be made.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Knowledge Test [ Time Frame: 2 - 3 weeks Post-Intervention ]
  True-False Test of knowledge gained from Decision Aid
• Treatment Preference [ Time Frame: 2 - 3 weeks Post-Intervention ]
  Coded responses to hypothetical change in condition presented as a case scenario
• Acute Care Transfers [ Time Frame: 3 months Post-Intervention ]
  Report of all hospitalizations

Original Secondary Outcome: Same as current

Information By: Florida Atlantic University

Dates:
Date Received: October 2, 2015
Date Started: October 2012
Date Completion:
Last Updated: October 5, 2015
Last Verified: October 2015