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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR009826 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision support | Experimental | Structured decision aid with prompting to share information in discussion with primary treating health care providers. |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding Options in Dementia Decision Aid | Other | Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider. |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflict Scale | Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent With Treatment Decisions | Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura C Hanson, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24083403 | Derived | Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19. | |
| 22091750 | Derived | Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15. |
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No enrolled participants were excluded before assignment
425 eligible dementia resident-surrogate dyads identified ; 118 surrogates refused, 41 unable to contact, and 10 unable to participate due to concurrent illness.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Support | Structured decision aid with prompting to share information in discussion with primary treating health care providers. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Support | Structured decision aid with prompting to share information in discussion with primary treating health care providers. |
| BG001 | Control | |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decisional Conflict Scale | Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict. | intention to treat | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decisions Support Intervention |
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Cluster randomization required, preventing double-blinding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura C. Hanson, MD, MPH | University of North Carolina Chapel Hill | 9199665945 | lhanson@med.unc.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 20729251 | Derived | Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Percent With Treatment Decisions | Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding. | Posted | Number | percentage of subjects | 3 months |
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| Post-Hoc | Percentage of Subjects With Weight Loss | Percentage of subjects with weight loss at 9 months | intention to treat | Posted | Number | percentage of participants | 9 months |
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|
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | Control | 0 | 129 | 0 | 129 |
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| D001523 | Mental Disorders |