Chronic DiseaseNCT02568475
Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions
A study testing Provision of "Go to the Hospital or Stay Here?" in people with Chronic Disease and Acute Disease, run by Florida Atlantic University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Disease, Acute Disease
- What is being tested?
- Provision of "Go to the Hospital or Stay Here?"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia as indicated by score on Mini-Cog. Inability to respond to questions due to physical disability or illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University, Christine E. Lynn College of Nursing
Boca Raton, Florida, 33431
About this study
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:
Read more
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.
Read the 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
- Chronic Disease, Acute Disease
- Being tested
- Provision of "Go to the Hospital or Stay Here?"
- Keywords
- nursing home residents, decision aid, acute care transfers
- Medical subject headings
- Chronic Disease, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of "Go to the Hospital or Stay Here?"Behavioural
Also called Transfer Decision Guide
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | Provision of "Go to the Hospital or Stay Here?" Receives: Behavioral: Provision of "Go to the Hospital or Stay Here?" |
| No decision aid | No intervention | Does not receive the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation for Decision Making
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.
Measured: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)
Decisional Conflict Scale
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
Measured: Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only
Secondary outcomes (3)
Knowledge Test
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
Measured: Pretest (baseline) and Post test (2-3 weeks after pretest)
Treatment Preference/Decisional Conflict Scale
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.
Measured: Post test (2-3 weeks after pretest)
30 Day Hospital Readmission
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.
Measured: Length of stay ≤30 days at Post test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Tappen, Florida Atlantic University
- Investigators
- Ruth M. Tappen, EdD, RN, FAAN, Principal investigator, Christine E. Lynn College of Nursing, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568475
- Sponsor's protocol ID
- 343268
- Other IDs
- 1IP2PI000281-01
- Status last verified
- Aug 2020
- First submitted
- 2 Oct 2015
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25275783
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involving Nursing Home Residents and Their Families in Acute Transfer Decisions: Pilot Test of a New Decision Aid
- ClinicalTrials.gov ID
- NCT02568475
- Acronym / sponsor ID
- 343268
- Conditions
- Chronic Disease, Acute Disease
- Keywords
- nursing home residents, decision aid, acute care transfers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Behavioral: Provision of "Go to the Hospital or Stay Here?"Provision of "Go to the Hospital or Stay Here?" |
| No decision aid | No intervention | –Does not receive the decision aid. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Dementia as indicated by score on Mini-Cog. Inability to respond to questions due to physical disability or illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of "Go to the Hospital or Stay Here?"Also: Transfer Decision GuideResidents 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. | Behavioural | Decision aid |
Primary outcome
Preparation for Decision Making
Time frame: 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.
Decisional Conflict Scale
Time frame: 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
3 secondary outcomes
Knowledge Test
Time frame: Pretest (baseline) and Post test (2-3 weeks after pretest)
Treatment Preference/Decisional Conflict Scale
Time frame: Post test (2-3 weeks after pretest)
30 Day Hospital Readmission
Time frame: Length of stay ≤30 days at Post test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25275783Tappen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth M. Tappen, EdD, RN, FAAN principal investigator
Christine E. Lynn College of Nursing, Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of "Go to the Hospital or Stay Here?" in people with Chronic Disease and Acute Disease, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparation for Decision Making (time frame: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.