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PPO 16-335 – HSR&D Study

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PPO 16-335
Pilot testing prehabilitation services aimed at improving outcomes of frail Veterans following major abdominal surgery
Daniel E. Hall MD MDiv MHSc
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, PA
Funding Period: January 2017 - September 2018

BACKGROUND/RATIONALE:
Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these patients.

"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call "prehabilitation." By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations.

OBJECTIVE(S):
We examined the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims were to:

(1) Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention;

(2) Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and

(3) Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living.

METHODS:
This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers.

Assessments will be made at baseline, every other week during prehabilitation, the week/day before surgery, and then again at 30 and 90 days after surgery. Inclusion criteria hinge on frailty as measured by the Risk Analysis Index (RAI), but frailty will be further assessed at multiple time points based on the RAI, Clinical Frail Scale, Edmonton Frail Scale and Fried Frail Scale. Physical performance will be assessed with the timed up and go, walking speed, grip strength, 6-minute walk test (6MWT) and the Short Physical Performance Battery (SPPB) to measure physical performance. Pulmonary function will be assessed with Maximal Inspiratory and Expiratory Pressures (MIP & MEP). Nutrition will be assessed with prealbumin and the 7-point Subjective Global Assessment. Standard postoperative outcomes (morbidity, mortality, length of stay) will be assessed by chart review. Survey instruments will be used to assess health-related quality of life, quality of surgical care, decision regret, preference for operative management, patient centeredness of care and satisfaction with the decision-making process. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention.

FINDINGS/RESULTS:
Aim 1 Findings: 54 eligible patients were approached to enroll 18 (recruitment rate: 33%). Of the 36 who declined participation, the most common reason was the excessive burden of travel (9/36 or 25%) or desire not to delay surgery (3/36 or 8%). Enrolled participants were equally randomized to prehabilitation or standard of care (9 in each group), but 3 crossed from prehabili to standard care and 5 crossed from standard care to prehab (chi-square 0.9, p=.34), leaving 11 patients in the prehab arm and 7 in the control arm. Overall retention rates were 83% and 61% at 30- and 90-days after surgery, respectively.

Duration of prehabilitation ranged from 3-10 weeks with a median of 4 weeks and a mean (standard deviation) of 5.7 (2.5). Compliance with the prescribed, on-site, hospital prehabilitation sessions was 94% overall and ranged from 82-100% among the prehabilitation patients. All patients were referred to physical therapy and nutrition as per protocol, and consults lasted approximately 15 minutes each. In-hospital training sessions lasted 90-120 minutes with 60-75 minutes of exercise and 30-40 minutes of instruction or assessment. Compliance with at-home exercise and nutrition logs was mixed: 3 of 10 (30%) returned their exercise logs demonstrating 90-100% compliance with exercise, but only 66% compliance with nutrition; the remaining participants did not return log books, but based on conversations, compliance was estimated between 0% and 80%. Nursing homes did not facilitate exercise, and overall out-of-hospital compliance was estimated at 55%.

Aim 1 Conclusions: Recruitment and retention procedures were proven feasible. However, burdens of participation limit enrollment and compliance with prescribed interventions, potentially limiting the effect of the intervention. Home-based prehabilitation is a potential solution to these barriers.


Aim 2 Findings: Measurement of frailty, physical performance, pulmonary function and nutrition was proven feasible at every time point. The prehabilitation group demonstrated clinically significant improvements in grip strength from 27 to 29 kg (p=0.006), MEP from 90 to 109 centimeters of water (p=0.02), and 6-minute walk test from 909 to 1070 meters (p=0.015). Other measures demonstrated changes in line with what would be expected, but were insufficiently powered for statistical significance. Overall, the prehabilitation group appeared more frail than the control group, and although they made modest improvements during prehabilitation, those improvements did not persist at 90-days after surgery, many deteriorating below baseline levels. By contrast, the control group deteriorated between baseline and surgery with regard to MEP (120 to 112, p=0.023), walking speed (1.54 to 1.07, p=0.024), and RAI score (25 to 29 (0.086), but largely recovered to baseline by 90-days after surgery. This may be due to more robust baseline performance among the control group as well as comparatively less invasive procedures.

Aim 2 Conclusions: Methods for assessing physical performance were proven feasible with clinically significant changes observed in both the prehabilitation and control groups in as few as 4 weeks. The added value of longer prehabilitation is uncertain.

Aim 3 Findings: There were no detectable differences in mortality, major complication or length of stay, though power was limited. Independent living at baseline and 90-days after surgery was unchanged, though as expected, several patients required increased levels of care at 30-days after surgery. There was no difference in health-related quality of life over time in the prehabilitation group, but among the control arm, quality of life improved from baseline to 90-days post op (0.67 to 0.8, p<.0001). The global rating of surgical care was identical in prehabilitation and control groups [8.4 on a scale from 1 (poor) to 10 (best)], indicating very good quality of care. Ratings for preoperative communication, operative recovery, and postoperative communication were all very good, ranging from 1.13-1.33 on a scale from 1 (good) to 3 (poor); the prehabilitation group had slightly higher scores, but the difference was not statistically significant.

There was no significant difference in decision regret between prehabilitation or control groups, or within groups over time. Patient centeredness of care trended to improve among prehabilitation patients from 1.78 to 1.42 (p=.086), but remained unchanged among the control group (1.46 to 1.56, p=.824). There was no difference between prehabilitation and control groups with respect to satisfaction with the decision-making process (2.19 vs 2.9, p=.252) or satisfaction with the decision (2.33 vs. 2.47, p=.346), though point estimates were better in the prehabilitation group (lower scores are better). Overall satisfaction with the diagnosis of frailty was equivocal in both groups (3.00 vs. 2.83, with 5 being perfect satisfaction and 3 being unsure). The prehabilitation patients were similarly equivocal about their overall satisfaction with their palliative care consultation (3.00). Both groups, however, were quite satisfied with the IMPACT clinic (4.46 and 4.63, respectively).

Aim 3 Conclusions: Methods for assessing postoperative outcomes were proven feasible, though as expected, this small pilot is insufficiently powered to detect significant change. Survey measures appear more sensitive to change and difference between groups and should be included in subsequent studies as secondary outcomes. Patient ambivalence about the "bad news" of their frailty diagnosis is understandable, and may indicate a target for quality improvement.

IMPACT:
Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each year.

PUBLICATIONS:
None at this time.


DRA: Aging, Older Veterans' Health and Care
DRE: Prevention, TRL - Applied/Translational
Keywords: none
MeSH Terms: none

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