Acute Disease, Chronic Disease
Conditions
Keywords
nursing home residents, decision aid, acute care transfers
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.
Interventions
BEHAVIORALProvision 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.
Sponsors
Florida Atlantic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preparation for Decision Making | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Test | 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 |
| Treatment Preference/Decisional Conflict Scale | 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. |
| 30 Day Hospital Readmission | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Provision of Go to the Hospital or Stay Here?
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. | 97 |
| No Decision Aid Does not receive the decision aid. | 95 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged home | 4 | 4 |
| Overall Study | Lost to Follow-up | 40 | 39 |
| Overall Study | Short-term: Discharge location unknown | 4 | 0 |
| Overall Study | Transferred to another facility | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Decision Aid | No Decision Aid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 78 Participants | 83 Participants | 161 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 12 Participants | 31 Participants |
| Age, Continuous | 76.69 years STANDARD_DEVIATION 12.72 | 79.3 years STANDARD_DEVIATION 13.94 | 78.05 years STANDARD_DEVIATION 13.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 86 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 20 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 87 Participants | 74 Participants | 161 Participants |
| Region of Enrollment United States Elsewhere | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Southeast Florida | 97 Participants | 95 Participants | 192 Participants |
| Sex: Female, Male Female | 66 Participants | 63 Participants | 129 Participants |
| Sex: Female, Male Male | 31 Participants | 32 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 95 |
| other Total, other adverse events | 0 / 97 | 0 / 95 |
| serious Total, serious adverse events | 0 / 97 | 0 / 95 |
Outcome results
Primary
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
Time frame: Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only
Population: Nursing Home Residents and Family Members. Only data for the Decision Aid group was collected for this outcome. The No Decision Aid Group, didn't receive the intervention and no data was analyzed before pre-test, therefore no data was collected. However, the score was analyzed in the No Decision Aid group (N=78) at the post-test time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid | Decisional Conflict Scale | Pretest | 13.11 score on a scale | Standard Deviation 12.01 |
| Decision Aid | Decisional Conflict Scale | Post test | 9.39 score on a scale | Standard Deviation 9.98 |
| No Decision Aid | Decisional Conflict Scale | Pretest | NA score on a scale | — |
| No Decision Aid | Decisional Conflict Scale | Post test | 15.73 score on a scale | Standard Deviation 14.68 |
p-value: 0.00195% CI: [2.9, 10.6]t-test, 2 sided
Primary
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.
Time frame: Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)
Population: This analysis only included those that received the Decision Aid intervention and were collected at the end of the intervention (Time Point 2) and with a 3-month follow-up. Only 39 participants were still residents in the nursing homes during the 3-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid | Preparation for Decision Making | Post test | 39.59 score on a scale | Standard Deviation 9.113 |
| Decision Aid | Preparation for Decision Making | 3 month follow-up | 36.00 score on a scale | Standard Deviation 10.084 |
p-value: 0.04695% CI: [0.059, 7.12]t-test, 2 sided
Secondary
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.
Time frame: Length of stay ≤30 days at Post test
Population: Nursing Home Residents and Family Members
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Aid | 30 Day Hospital Readmission | 8 Participants |
| No Decision Aid | 30 Day Hospital Readmission | 5 Participants |
Secondary
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
Time frame: Pretest (baseline) and Post test (2-3 weeks after pretest)
Population: Nursing Home Residents and Family Members
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid | Knowledge Test | Pretest | 15.63 score on a scale | Standard Deviation 2.69 |
| Decision Aid | Knowledge Test | Post test | 17.38 score on a scale | Standard Deviation 2.86 |
| No Decision Aid | Knowledge Test | Pretest | 15.19 score on a scale | Standard Deviation 2.64 |
| No Decision Aid | Knowledge Test | Post test | 15.80 score on a scale | Standard Deviation 2.56 |
Secondary
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.
Time frame: Post test (2-3 weeks after pretest)
Population: Nursing Home Residents and Family Members
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Decision Aid | Treatment Preference/Decisional Conflict Scale | Prefer Hospital | 17 participants |
| Decision Aid | Treatment Preference/Decisional Conflict Scale | Prefer Nursing Home | 17 participants |
| Decision Aid | Treatment Preference/Decisional Conflict Scale | No Response | 50 participants |
| No Decision Aid | Treatment Preference/Decisional Conflict Scale | Prefer Hospital | 23 participants |
| No Decision Aid | Treatment Preference/Decisional Conflict Scale | Prefer Nursing Home | 6 participants |
| No Decision Aid | Treatment Preference/Decisional Conflict Scale | No Response | 49 participants |