EAL

MNT: Cost Effectiveness, Cost-benefit, or Economic Savings of MNT (2009)

Citation:

Stern JM, Bruemmer B, Moinpour C, Sullivan KM, Lenssen P, Aker SN. Impact of a randomized, controlled trial of liberal vs. conservative hospital discharge criteria of energy, protein and fluid intake in patients who received marrow transplants. J Am Diet Assoc. 2000; 100: 1,015-1,022.

PubMed ID: 11019348

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To assess the safety and cost-effectiveness of adult patients who received marrow transplants and determine if they had faster resumption of oral energy and nutrient intake and shorter duration of intravenous (IV) fluid requirement if discharged from the hospital earlier than is customary.

Inclusion Criteria:

Patients who consumed less than 33% of estimated energy requirements and required up to 3,000ml of fluid per day intravenously for three consecutive days met the study entry criterion.

Exclusion Criteria:

Were not afebrile
Did not have an absolute neutrophil count of more than 500cm³for 48 hours
Did not have a stool volume less than 500ml per day
Did not have a caregiver trained to perform central line care and operate an IV pump
Did not give informed consent.

Description of Study Protocol:

Recruitment

Patients who received marrow transplant and consumed less than 33% of estimated energy requirement for three consecutive days were recruited from the Fred Hutchinson Cancer Research Center from July, 1989 through August, 1991.

Design

Randomized controlled trial of patients remaining hospitalized because of inadequate oral intake. Consenting patient were assigned randomly, within 24 hours, to remain hospitalized (control group and hospital group) or be discharged to an ambulatory setting with health care support at home (ambulatory group).

Intervention

Hospital Group: Patients that remained hospitalized received standard nutrition services, including provision of parenteral nutrition by the hospital pharmacy, a weighed or measured diet and counseling by a dietitian or dietetic technician to promote resumption of oral intake at least once weekly. At discharge from the hospital, a dietitian instructed the patient's record keeper in the procedures to record oral intake volumes of all foods and fluids using standard measuring utensils.
Ambulatory Group: Patients were instructed to record daily oral intake volumes in the same way as the hospital group. Patients attended the ambulatory-care clinic a minimum of once weekly for multidisciplinary assessment, including nutrition counseling by a dietitian.

Statistical Analysis

The statistical analysis system was used for data analysis. Demographic data were described by group with mean and standard deviation. Differences by treatment are in time to meet energy, protein, parenteral nutrition and IV hydration goals and were each evaluated by Cox regression analysis.

Data Collection Summary:

Timing of Measurements

July, 1989 through August, 1991.

Dependent Variables

Energy requirements (days to consume 33% of estimated needs)
Protein requirements (days to consume 33% of estimated needs)
Parenteral nutrition (initiated for all study participants, continued until oral energy intake began to increase)
Intravenous fluid support (discontinued when oral intake provided adequate fluid volume)
Cost data for professional nutrition consultations and assessments, energy and nutrient intake analysis, and enteral supplements provided in the ambulatory clinic.

Independent Variables

Hospital Group: Patients who remain hospitalized received standard nutrition services, including provision of parenteral nutrition by the hospital pharmacy, a weighed or measure diet and counseling by a dietitian or dietetic technician to promote resumption of oral intake at least once weekly. At discharge from the hospital, a dietitian instructed the patient's record keeper in the procedures to record oral intake volumes of all foods and fluids using standard measuring utensils.
Ambulatory Group: Patients were instructed to record daily oral intake volumes in the same way as the hospital group. Patients attended the ambulatory care clinic a minimum of once weekly for multidisciplinary assessment, including nutrition counseling by a dietitian.

Control Variables

Prednisone therapy received within five days of discontinuation of parenteral nutrition was evaluated as a time-dependent variable in resumption of oral intake and cessation of parenteral nutrition and IV hydration
Potential confounding factors were GI and oral symptom scores, methotrexate therapy, prednisone therapy, acute graft vs. host disease and radiation.

Description of Actual Data Sample:

Initial N: 78 patients (29 male)
Attrition (final N): 73 (three died, one relapsed and one discharged from the center with continued poor oral intake).

Age

Hospital Group: 20.3 years (mean age)
Ambulatory Group: 23.2 years (mean age).

Anthropometrics

The groups were well-stratified for type of transplant, age and number of days post-transplantation at time of randomization. The randomization process resulted in even distribution by disease and gender. No differences occurred between study groups in the number receiving total body irradiation as part of conditioning therapy, methotrexate as graft-vs.-host disease prophylaxis, oral or GI toxicity scores at study entry or frequency of grade of acute graft-vs.-host disease among subjects receiving allogeneic or unrelated donor grafts.

Location

Seattle, Washington, US.

Summary of Results:

Variables	Hospital Group		Ambulatory Group		Statistical Significance of Group Difference P-Value
Variables	Median	10th, 90th Percentiles	Median	10th, 90th Percentiles	Statistical Significance of Group Difference P-Value
Days After Study Entry to Meet Discharge Energy Criteria	4.5	2, 7	8	2, 37	0.004
Days After Study Entry to Consume 33% of Protein Requirements	11	5, 34	9	3, 42	0.470
Days After Study Entry to Discontinue Parenteral Nutrition	22	7, 43.5	17	5, 49	0.817
Days After Study Entry to Discontinue All IV Fluids	30.5	14, 59	48.5	12, 71	0.019

Other Findings

The charges for nutrition consultations were similar for the hospital and ambulatory groups
The mean patient charge per study week for the hospital group was $32.89±$8.99; for the ambulatory group it was $33.17±$8.88
The mean patient consultation time in minutes per study week was 51.2±13.6 for the hospital group and 52.0±12.2 for the ambulatory group
Total volumes of parenteral nutrition and IV hydration required were similar between groups; however, the median charges for IV fluids was $739 ($99 per liter of PN, $17 per liter of IV hydration) for hospital group and $4,557 ($351 per liter of PN, $37 to $72 per liter of IV hydration) for the ambulatory group
The hospital group took fewer days than the ambulatory group to resume oral energy intake (4.5 vs. 8.0, P=0.004) and to discontinue IV fluids (30.5 vs. 48.5, P=0.019)
There was no difference between groups in days of parenteral nutrition support (P=0.817) or days to resume oral protein intake (P=0.470).

Author Conclusion:

Earlier hospital discharge can achieve cost savings but may delay resumption of oral energy intake. Nutrition assessment and counseling are necessary in both the hospital and ambulatory setting to promote resumption of oral intake and discontinuation of IV fluids. The charges for professional nutrition assessment and consultation, food record analysis and oral nutrition supplements were not different between the hospital group and ambulatory group.

Funding Source:

University/Hospital:

Turlane University, Jewish Hospital and Medical Center of Brooklyn

Reviewer Comments:

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes