Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142903
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-15
Brief Title:
Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
THE COMPARATIVE EFFECTIVENESS OF 7 VERSUS 21 HOME-DELIVERED MEDICALLY TAILORED MEALS TO IMPROVE MALNUTRITION RISK IN MALNOURISHED PATIENTS WITH HEART FAILURE A RANDOM ORDER CROSSOVER FEEDING TRIAL MEDIMEALS
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure HF and malnutrition risk or malnutrition at hospital discharge This random order crossover design will provide evidence as to whether the provision of dinner meals alone versus all 3 daily meals to patients homes is more effective at improving malnutrition risk score and secondarily unplanned emergency department visits and readmissions
Detailed Description:
11 Background and Relevant Literature Heart failure HF is a common clinical syndrome occurring in 62 million adults in the US with a cost of 307 million in 2012 due to health care services medications and missed days of work The symptoms of HF result from the impaired ability of the heart to deliver blood and oxygen adequately to peripheral tissues
Patients with HF at the Hospital of the University of Pennsylvania experience worse than expected clinical outcomes Length of hospital stay in FY2021 mean LOS 749 d expected LOS 66 d and FY22 mean 721 d expected 66 d and 30-day readmissions were 171 in FY21 and 173 in FY22
Malnutrition is a common comorbid condition with HF In an observation of 4000 patients with HF 57 had at least mild malnutrition a condition that was associated with increased mortality The malnutrition reported with HF comprises protein-energy malnutrition muscle wasting and cachexia variables evaluated during malnutrition assessment
Patients with malnutrition have worse clinical outcomes Patients at our hospital who had moderate or severe disease-related malnutrition during the hospital stay had significantly more 30-day readmissions 40 versus 23 OR 213 182-248 greater mortality OR 147 10-199 and longer length of stay 15 vs 12 days p 00067 than patients who did not meet criteria for malnutrition4 In data from the 2012-2014 Nationwide Inpatient Sample malnutrition was associated with mortality OR of 248 23-266 almost double the admission cost and longer length of stay of 87 days 85-86 vs 53 52-535
The mainstay of HF disease management is patient self-management of medications diet restriction of Na with limited alcohol and fluid restriction to 15-2 L daily Daily self-weighing is a strategy to detect fluid accumulation and permit adjustment of fluid intake or medical therapy In addition to a Na restriction the Diet Approach to Stop Hypertension or Mediterranean diet has been suggested To optimize cardiovascular health and reduce cardiac deaths and strokes by 20 the 2020 American Heart Association AHA guidelines included an evidence-based dietary approach targeting servings of six food groups optimal intake of whole grains fruitsvegetables nutsseedslegumes and fish with limited intake of processed meats and sweet beverages8 and with restriction of sodium intake to 1500 mg and saturated fat to 7 of kcal The DASH diet approach emphasizes intake of fruits vegetables whole grains dairy nutsseedslegumes and limits intake of meat sweets and fats A six-month nutrition intervention that included oral nutrition supplements in malnourished patients with HF significantly reduced mortality
While readmissions in patients with HF are generally attributed to disease exacerbations the disease exacerbations may be related to diet Patients with HF should follow a strict Na-restricted heart healthy diet as a strategy to limit fluid accumulation that can exacerbate symptoms of edema bloating and dyspnea However disease-related symptoms of fatigue or dyspnea may make preparing such a diet challenging because meals must be prepared without the use of processed or commercial frozen food items due to their high sodium and fat content
Clinicians often treat patients with HF in the ED during emergency department visits EDV to avoid formal hospital admissions though data on this outcome are not commonly reported However EDVs are disruptive to the quality of life of the patient and utilize hospital resources We hypothesize that reducing malnutrition risk by providing medically-tailored meals may provide protection against 30-day unplanned readmissions and EDV
Simple interventions such as provision of medically-tailored meals to the patients home setting hold the potential to improve malnutrition and prevent both EDV and readmissions One pilot trial compared 21 mealsweek to standard care in patients with HF with a trend towards fewer readmissions in the meals treatment arm A small pilot in elderly patients 38 of whom were diagnosed with HF determined that it was feasible to provide 10 days of home-delivered meals but lacked statistical power to determine the impact on readmissions by 45 days However there are no data to determine whether dinner meals alone will provide equivalent outcomes to 21 mealsweek or whether provision of medically tailored meals can improve malnutrition risk or reduce EDVs or readmissions
2 Study Objectives The overall objective of the study is to determine whether the provision of 7 or 21 medically tailored meals per week to the patient in their home setting can improve malnutrition risk MST score and secondarily reduce 30-day unplanned EDV readmissions and improve diet quality by PDH score
21 Primary Objective To compare the effectiveness of home delivery of 7 versus 21 medically-tailored meals per week on improvement reduction in malnutrition risk MST score
22 Secondary Objectives
To compare the effectiveness of home delivery of 7 versus 21 medically-tailored meals per week on unplanned 30-day EDV or readmissions and PHD score
3 Investigational Plan Patients with HF who are identified with moderate or severe malnutrition during their HUP admission will be offered participation in the random order crossover design home-based feeding trial Telephone visits with the patient at day 05 305 and 605 will be used to gather MST PHD SARC-F calf circumference and weight data The meals will be delivered weekly to the patients home address by MANNA The EDV and readmission outcomes will be adjudicated by the clinical dietitian in consultation with the cardiology medical team as planned or unplanned events Adverse events will be adjudicated for seriousness and relatedness to the diet intervention by Dr Bruce Kinosian the studys safety officer
31 General Design Consented patients will be randomized using a computer-generated scheme to delivery of either 7 dinner meals or 21 meals 7 breakfast 7 lunch 7 dinner meals each week for 4 weeks duration At approximately day 0 30 and 60 relative to discharge from the hospital patients will be contacted by telephone to assess their MST score diet quality relative to AHA dietary goals and obtain their self-measured weight and calf circumference
32 Allocation to Interventional Group Subjects will be randomized in a one to one fashion to the order of 7 versus 21 mealsweek intervention for one month followed immediately by the other treatment arm using a computer-generated algorithm designed by the study statistician MANNA contacts will be aware of the treatment arm assignment but the study personnel will be blinded Because the study meals are provided using the same foods a washout period is not indicated
33 Study Measures Each of the following tools will be collected by telephone contact with enrolled patients at approximately 0 30 and 60 days relative to hospital discharge
The Malnutrition Screening Tool MST score ranges from 0-5 with higher scores indicating greater risk of malnutrition
The Penn Healthy Diet Survey PHD score ranges 0-64 with higher scores indicating a healthier diet
Sarcopenia Screening Tool SARC-F score ranges 0-10 with higher results indicating greater debility
Calf Circumference will be measured in cm by the patient or a caregiver at the maximum diameter of the calf using a paper measuring tape provided by the study prior to discharge
Weight measured on the day of the telephone call will be recorded
Adherence to medically-tailored meals will be determined by asking the patient how many of the meal entrees they were able to consume in the prior week
Patients with HF at the Hospital of the University of Pennsylvania experience worse than expected clinical outcomes Length of hospital stay in FY2021 mean LOS 749 d expected LOS 66 d and FY22 mean 721 d expected 66 d and 30-day readmissions were 171 in FY21 and 173 in FY22
Malnutrition is a common comorbid condition with HF In an observation of 4000 patients with HF 57 had at least mild malnutrition a condition that was associated with increased mortality The malnutrition reported with HF comprises protein-energy malnutrition muscle wasting and cachexia variables evaluated during malnutrition assessment
Patients with malnutrition have worse clinical outcomes Patients at our hospital who had moderate or severe disease-related malnutrition during the hospital stay had significantly more 30-day readmissions 40 versus 23 OR 213 182-248 greater mortality OR 147 10-199 and longer length of stay 15 vs 12 days p 00067 than patients who did not meet criteria for malnutrition4 In data from the 2012-2014 Nationwide Inpatient Sample malnutrition was associated with mortality OR of 248 23-266 almost double the admission cost and longer length of stay of 87 days 85-86 vs 53 52-535
The mainstay of HF disease management is patient self-management of medications diet restriction of Na with limited alcohol and fluid restriction to 15-2 L daily Daily self-weighing is a strategy to detect fluid accumulation and permit adjustment of fluid intake or medical therapy In addition to a Na restriction the Diet Approach to Stop Hypertension or Mediterranean diet has been suggested To optimize cardiovascular health and reduce cardiac deaths and strokes by 20 the 2020 American Heart Association AHA guidelines included an evidence-based dietary approach targeting servings of six food groups optimal intake of whole grains fruitsvegetables nutsseedslegumes and fish with limited intake of processed meats and sweet beverages8 and with restriction of sodium intake to 1500 mg and saturated fat to 7 of kcal The DASH diet approach emphasizes intake of fruits vegetables whole grains dairy nutsseedslegumes and limits intake of meat sweets and fats A six-month nutrition intervention that included oral nutrition supplements in malnourished patients with HF significantly reduced mortality
While readmissions in patients with HF are generally attributed to disease exacerbations the disease exacerbations may be related to diet Patients with HF should follow a strict Na-restricted heart healthy diet as a strategy to limit fluid accumulation that can exacerbate symptoms of edema bloating and dyspnea However disease-related symptoms of fatigue or dyspnea may make preparing such a diet challenging because meals must be prepared without the use of processed or commercial frozen food items due to their high sodium and fat content
Clinicians often treat patients with HF in the ED during emergency department visits EDV to avoid formal hospital admissions though data on this outcome are not commonly reported However EDVs are disruptive to the quality of life of the patient and utilize hospital resources We hypothesize that reducing malnutrition risk by providing medically-tailored meals may provide protection against 30-day unplanned readmissions and EDV
Simple interventions such as provision of medically-tailored meals to the patients home setting hold the potential to improve malnutrition and prevent both EDV and readmissions One pilot trial compared 21 mealsweek to standard care in patients with HF with a trend towards fewer readmissions in the meals treatment arm A small pilot in elderly patients 38 of whom were diagnosed with HF determined that it was feasible to provide 10 days of home-delivered meals but lacked statistical power to determine the impact on readmissions by 45 days However there are no data to determine whether dinner meals alone will provide equivalent outcomes to 21 mealsweek or whether provision of medically tailored meals can improve malnutrition risk or reduce EDVs or readmissions
2 Study Objectives The overall objective of the study is to determine whether the provision of 7 or 21 medically tailored meals per week to the patient in their home setting can improve malnutrition risk MST score and secondarily reduce 30-day unplanned EDV readmissions and improve diet quality by PDH score
21 Primary Objective To compare the effectiveness of home delivery of 7 versus 21 medically-tailored meals per week on improvement reduction in malnutrition risk MST score
22 Secondary Objectives
To compare the effectiveness of home delivery of 7 versus 21 medically-tailored meals per week on unplanned 30-day EDV or readmissions and PHD score
3 Investigational Plan Patients with HF who are identified with moderate or severe malnutrition during their HUP admission will be offered participation in the random order crossover design home-based feeding trial Telephone visits with the patient at day 05 305 and 605 will be used to gather MST PHD SARC-F calf circumference and weight data The meals will be delivered weekly to the patients home address by MANNA The EDV and readmission outcomes will be adjudicated by the clinical dietitian in consultation with the cardiology medical team as planned or unplanned events Adverse events will be adjudicated for seriousness and relatedness to the diet intervention by Dr Bruce Kinosian the studys safety officer
31 General Design Consented patients will be randomized using a computer-generated scheme to delivery of either 7 dinner meals or 21 meals 7 breakfast 7 lunch 7 dinner meals each week for 4 weeks duration At approximately day 0 30 and 60 relative to discharge from the hospital patients will be contacted by telephone to assess their MST score diet quality relative to AHA dietary goals and obtain their self-measured weight and calf circumference
32 Allocation to Interventional Group Subjects will be randomized in a one to one fashion to the order of 7 versus 21 mealsweek intervention for one month followed immediately by the other treatment arm using a computer-generated algorithm designed by the study statistician MANNA contacts will be aware of the treatment arm assignment but the study personnel will be blinded Because the study meals are provided using the same foods a washout period is not indicated
33 Study Measures Each of the following tools will be collected by telephone contact with enrolled patients at approximately 0 30 and 60 days relative to hospital discharge
The Malnutrition Screening Tool MST score ranges from 0-5 with higher scores indicating greater risk of malnutrition
The Penn Healthy Diet Survey PHD score ranges 0-64 with higher scores indicating a healthier diet
Sarcopenia Screening Tool SARC-F score ranges 0-10 with higher results indicating greater debility
Calf Circumference will be measured in cm by the patient or a caregiver at the maximum diameter of the calf using a paper measuring tape provided by the study prior to discharge
Weight measured on the day of the telephone call will be recorded
Adherence to medically-tailored meals will be determined by asking the patient how many of the meal entrees they were able to consume in the prior week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None