Dementia
Conditions
Keywords
Dementia, Nutrition, Feeding
Brief summary
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.
Detailed description
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.
Interventions
OTHERFeeding Options in Dementia Decision Aid
Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.
Sponsors
National Institute of Nursing Research (NINR)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* dementia diagnosis * advanced cognitive impairment * feeding problem * age \>= 65 * surrogate decision maker
Exclusion criteria
* feeding tube decision made * hospice * BMI \> 26 * major psychosis or developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | 3 months | Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent With Treatment Decisions | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
425 eligible dementia resident-surrogate dyads identified ; 118 surrogates refused, 41 unable to contact, and 10 unable to participate due to concurrent illness.
Pre-assignment details
No enrolled participants were excluded before assignment
Participants by arm
| Arm | Count |
|---|---|
| Decision Support Structured decision aid with prompting to share information in discussion with primary treating health care providers. | 127 |
| Control | 129 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Control | Decision Support | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 129 Participants | 127 Participants | 256 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 85.3 years STANDARD_DEVIATION 2.3 | 85.2 years STANDARD_DEVIATION 2.1 | 85.2 years STANDARD_DEVIATION 2.1 |
| Region of Enrollment United States | 129 participants | 127 participants | 256 participants |
| Sex: Female, Male Female | 98 Participants | 97 Participants | 195 Participants |
| Sex: Female, Male Male | 31 Participants | 30 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 129 |
| serious Total, serious adverse events | 0 / 127 | 0 / 129 |
Outcome results
Primary
Decisional Conflict Scale
Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.
Time frame: 3 months
Population: intention to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Support Intervention | Decisional Conflict Scale | 1.65 units on a scale |
| Control | Decisional Conflict Scale | 1.97 units on a scale |
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Support Intervention | Percent With Treatment Decisions | 46 percentage of subjects |
| Control | Percent With Treatment Decisions | 33 percentage of subjects |
Post Hoc
Percentage of Subjects With Weight Loss
Percentage of subjects with weight loss at 9 months
Time frame: 9 months
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Support Intervention | Percentage of Subjects With Weight Loss | 6 percentage of participants |
| Control | Percentage of Subjects With Weight Loss | 16 percentage of participants |