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

2020年8月14日 更新者:Ruth Tappen、Florida Atlantic University

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

192

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Florida
      • Boca Raton、Florida、アメリカ、33431
        • Florida Atlantic University, Christine E. Lynn College of Nursing

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

21年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Decision aid
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.
他の名前:
  • Transfer Decision Guide
介入なし:No decision aid
Does not receive the decision aid.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Preparation for Decision Making
時間枠: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.

Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)
Decisional Conflict Scale
時間枠: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

Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

二次結果の測定

結果測定
メジャーの説明
時間枠
Knowledge Test
時間枠: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

Pretest (baseline) and Post test (2-3 weeks after pretest)
Treatment Preference/Decisional Conflict Scale
時間枠: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.
Post test (2-3 weeks after pretest)
30 Day Hospital Readmission
時間枠: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.
Length of stay ≤30 days at Post test

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Ruth M. Tappen, EdD, RN, FAAN、Christine E. Lynn College of Nursing, Florida Atlantic University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年10月1日

一次修了 (実際)

2015年9月1日

研究の完了 (実際)

2015年9月1日

試験登録日

最初に提出

2015年10月2日

QC基準を満たした最初の提出物

2015年10月5日

最初の投稿 (見積もり)

2015年10月6日

学習記録の更新

投稿された最後の更新 (実際)

2020年8月31日

QC基準を満たした最後の更新が送信されました

2020年8月14日

最終確認日

2020年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 343268
  • 1IP2PI000281-01 (その他の助成金/資金番号:Patient-Centered Outcomes Research Institute)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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