UWL: Medical Nutrition Therapy (2007)

Citation:
 
Study Design:
Class:
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Quality Rating:
Research Purpose:

To identify the rate of unintentional weight loss in adults following their admission into residential healthcare facilities, assess the effectiveness of a new medical nutrition therapy protocol for the prevention and treatment of unintentional weight loss and describe nutrition assessment and intervention activities of dietitians.

Inclusion Criteria:

Inclusion criteria for dietitians not described. Dietitians were instructed to sequentially invite all adults (21 and older), up to a maximum of 20, who were admitted to their healthcare facilities during a three-month recruitment period. 

Exclusion Criteria:

Exclusion criteria for dietitians not described. Adults entering hospice, respite care program or those expected to have a short-term stay of less than 30 days were excluded.

Description of Study Protocol:

Recruitment

Volunteer dietitians were recruited via announcement in CD-HCF publications and at national and state meetings. Interested dietitians were mailed a study overview, study expectations and consent forms. Enrollment was from November 1998 to June 1999. 

Design

Randomized clinical trial. Volunteer dietitians were randomly assigned to usual nutrition care or MNT protocol care groups using a random numbers table.

Intervention

  • Usual nutrition care, using existing definition for significant weight loss
  • MNT protocol care: Emphasized assessment; intervention (including weighing frequency); communication with staff, medical doctor, family and resident; and reassessment, using weight loss criteria defined in the protocol. 

Statistical Analysis

  • Desired sample size to detect significant differences in unintentional weight loss was 400 residents
  • Dietitian and facility characteristics were compared between groups using the chi-square test
  • Descriptive statistics were used to describe residents, characterize nutrition care and resident outcomes and make comparisons between groups
  • Discharge from the facility and missing data led to varying numbers in the analyses
  • Resident characteristics were compared between groups using an independent T-test and chi-square test
  • Chi-square and independent T-tests were used to test differences between groups, and repeated measures ANOVA was used to test the effect of nutrition care group on weight change while controlling for gender
  • Multivariate analysis using the general linear model was used to explore the association of oral and nutritional risks and health conditions on weight outcomes.
Data Collection Summary:

Timing of Measurements

Dietitians recruited newly admitted residents and tracked their weights for up to six months. Weighing was expected at admission and 90 days later. If residents were identified with significant unintended weight loss within the first 90 days post-admission, their weight was tracked for an additional 90 days following identification.

Dependent Variables

  • Rate of unintentional weight loss
  • Weight status 90 days after admission
  • Weight status 90 days after identification of unintentional weight loss
  • Weights were taken from medical or other records
  • Due to weighing schedules within facilities, weights were accepted if they were within a 14-day window
  • Medical record audit forms including age, gender, admitting diet, disease information and MDS data collected for each enrolled resident
  • Documented nutrition care activities related to assessment, intervention and staff involvement were noted using a checklist.

Independent Variables

  • Usual nutrition care
  • MNT protocol care
  • Compliance with study procedures ascertained through midpoint dietitian feedback survey.

Control Variables

Demographic information regarding gender, race, higher education, number of years working in residential healthcare facilities and information about the facility collected through dietitian questionnaire.

Description of Actual Data Sample:
  • Initial N: 96 dietitians volunteered and received the recruitment packet, and 36 completed the consent form and dietitian questionnaire and were randomized (20 MNT, 16 usual care)
  • Attrition (final N): 31 dietitians from 29 facilities completed the field test (16 MNT, 13 usual care). Medical record data were available for 394 residents (223 MNT, 171 usual care) and complete weight trend data were available for 364 residents (200 MNT, 164 usual care). Reasons for dietitian withdrawal not mentioned. 11 dietitians in the MNT group and 13 dietitians in the usual care group returned the midpoint dietitian survey.
  • Age: Dietitian age was not mentioned. Resident age ranged from 38 to 100 years (mean 81.7±9.2 years).
  • Anthropometrics: There were no significant differences between MNT and usual care groups
  • Location: United States. 
Summary of Results:

Other Findings

  • 14 of 364 residents (4%) were admitted with significant pre-existing weight loss, which was successfully treated in eight residents during the first 90 days
  • Substantial unintentional weight loss (more than 5% in any 30 days) developed in 78 residents (21%)
  • Women developed significant weight loss more often than men (24% vs. 16.7%) and unintended weight loss was more likely to go unidentified in women than men (6.0% vs. 1.9%).
  • Factors found to be associated with weight change from admission to 90 days were the following: Gender (female, 91.022, P=0.000), Alzheimer's disease (female, 4.144, P=0.043) and on a therapeutic diet (female, 5.153, P=0.024)
  • MNT-protocol care dietitians were more likely to identify unintentional weight loss
  • When unintentional weight loss was identified, and after providing nutrition care to these residents for an additional 90 days, 32 of 61 residents (52%) maintained or gained weight
  • Dietitians in usual care and MNT-protocol care groups were equally successful in treating pre-existing or post-admission unintentional weight loss when it was identified
  • Differences were found in nutrition care activities. MNT-protocol care dietitians reported more nutrition assessment activities, whereas usual care dietitians reported more intervention activities.
  • For residents with weight loss problems, usual care dietitians more frequently talked with and instructed staff, educated resident or family members, talked with MDs and recommended alternative feeding routes
  • MNT dietitians tended to recommend diet modification, appetite enhancers, and increased weighing frequency for residents with weight loss problems; in contrast, usual care dietitians recommended feeding assistance and supplements for residents with or without weight-loss problems. 
Author Conclusion:

Nutrition care protocols with standardized weighing procedures can increase the identification of unintentional weight loss in the residential healthcare environment. Improved identification supports the additional assessment activities used by MNT-protocol care dietitians. Similar outcomes for usual care and MNT-protocol care groups when unintentional weight loss was identified indicate that usual nutrition care was already a high standard of care for intervention.

Funding Source:
Other: None reported
Reviewer Comments:

Inclusion and exclusion criteria for dietitians not described. Weights were accepted if within a 14-day window. Usual care interventions were not necessarily similar enough for comparison. Discharge from the facility and missing data led to varying numbers in the analyses. Authors note the following limitations:

  • Dietitians were self-selected and may not be representative of other dietitians in residential healthcare facilities
  • Sample size of 394 came close to calculated sample size of 400, but weight data were incomplete for 12% of the sample
  • MNT and usual care groups differed in the extent of residents' oral and nutritional problems, diagnoses and health conditions
  • Lacked control over actual weighing and therefore precision and reliability of weights
  • Volunteer dietitians had responsibility for data collection at their own facilities, raising the potential of bias and possible inconsistency between sites.
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? ???
  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? No
  2.2. Were criteria applied equally to all study groups? No
  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? ???
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? ???
  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? ???
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? No
  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? N/A
  6.6. Were extra or unplanned treatments described? N/A
  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