Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE ...

Multicenter OsteopathicPneumonia Study in the Elderly(MOPSE)The Primary Outcomes

BACKGROUND

MOPSE(Multicenter Osteopathic Pneumonia Study in the Elderly)• A registered study at www.clinicaltrials.gov• Conducted between March 2004 and April 2007• Protocol Paper: www.jaoa.edu– Noll DN, Degenhardt BF, Fossum C, and Hensel K. Clinical andResearch Protocol for Osteopathic Manipulative Treatment of ElderlyPatients with Pneumonia JAOA September 2008; 108: 508-516• Main Outcomes Paper: www.om-pc.com– Noll DR, Degenhardt BF, Morley FM, Blais FX, Hortos FA, Hensel K,Johnson CJ, Pasta DJ, and Stoll ST. Efficacy of osteopathicmanipulation as an adjunctive treatment for hospitalized patients withpneumonia: a randomized d controlled trial. Osteopathic thi Medicine i andPrimary Care 2010, 4:2

Funded by a Consortium ofOsteopathic Foundations• Brentwood Foundation (Ohio)• Colorado Springs Osteopathic Foundation (Colorado)• Foundation for Osteopathic Health Services (Maryland)• Muskegon General Osteopathic Foundation (Michigan)• Northwest Oklahoma Osteopathic Foundation (Oklahoma)• Osteopathic Founders Foundation (Oklahoma)• Osteopathic Institute of the South (Georgia)• Osteopathic Heritage Foundation (Ohio)• Quad City Osteopathic Foundation (Iowa)

Multicenter study structureOsteopathicFoundationsOsteopathicResearchCenter in FortWorth, TexasOhio –DoctorsHospitalAT Still ResearchInstitute inKirksville,MissouriNew Jersey– KennedyStratfordMichigan –MountClemensMissouri –NERMCTexas –OMCT,Plaza &John PeterSmith

Study Methods

Primary Hypothesis• Osteopathic Manipulative Treatmentwill:– Reduce length of stay (LOS)– Reduce time to clinical stability– Improve the symptomatic and functionalrecovery e score

Length of stay (LOS)• A traditional measure• Taken from the time and date the order waswritten for;– Admission– Discharge• Or the closest approximation found in the chart• At midnight, a new day starts

MOPSE Key Aspects (Slide I)1. Randomized Controlled Clinical Trial• Efficacy study, not a mechanistic study2. Seamless Design• Not to interfere with usual care3. Blinded Study• For the decision makers4. Three arm study design• OMT group• Light touch “sham” group• Conventional care only group

MOPSE Key Aspects (Slide II)5. OMT is an adjunctive treatment modality• Does not replace conventional care6. Balances uniformity with individualization• 15 minutes standard, 5 minutes specific7. Best effect design over pragmatic design• Build upon the previous studies8. 24 hour window• From admission to first treatment

Inclusion Criteria• Age ≥ 50 years• NEW pulmonary infiltrate on x-ray• Two of the following–New, increased cough–Fever ≥ 38 degrees Centigrade–Pleuritic chest pain–New findings on physical exam–Respiratory rate ≥ 25 bpm–Mental status change–WBC ≥ 12,000 cells/mm 3

Eight Standardized Techniques1. Thoracolumbar soft tissue2. Rib raising3. Doming of the diaphragm myofascial release4. Cervical soft tissue5. Suboccipital i decompression6. Thoracic inlet myofascial release7. Thoracic lymphatic pump8. Pedal lymphatic pump

MOPSE Study Design SummarySubjectOMTGroupShamTreatmentGroupUsual CareOnly GroupOMT: Twice a day7 days a week15 minutesdurationSham: Twice-a-day7 days a week15 minutesdurationPrimary Outcomes:1) Length of HospitalStay2) Time to ClinicalStability3) Rate of Symptomaticand FunctionalRecoverySecondary Outcomes:• Duration of IV and oralantibiotic treatment• Treatment Endpoints:Death, RespiratoryFailure and Discharge• 60-day Re-admission• Success in Blinding

Subject Recruitment(from seven community hospitals)3,426 Screened2,883Not Eligible543 Eligible137Declined406 Randomized

Demographics• Antibiotic Selection– 84% agreement with practice guidelines• Demographics– No differences, except• Aspiration risk (LT > CCO) by ITT analysis• Current Alcohol Use (OMT < LT, CCO) by PP analysis• Pneumonia Severity Index– no between group differences

Randomization and Numbers406 RandomizedOMT LT CCO135 Assigned 136 Assigned 135 Assigned130 ITT 124 ITT 133 ITT96 PP 95 PP127 PPITT = Intention to treat statistical analysisPP = Per protocol statistical analysis

Mean LOSOMT LT CCOIntention to treat analysisn = 130 n = 124 n = 1334.5 days4.9 days4.5 days(SD 2.7) (SD 2.7 (SD 2.6)p = 0.53Per protocol analysisn = 96 n = 95 n = 1274.0 days4.44 days4.5 daysp =0010.01(SD 2.0)(SD 2.4)(SD 2.6)(OMT

Time to Clinical StabilityOMT LT CCOIntention to treat analysisn = 121 n = 118 n = 1302.5 days2.5 days2.6 days(SD 1.6) (SD 14) 1.4) (SD 16) 1.6)p = 0.97Per protocol analysisn = 90 n = 90 n = 1242.3 days2.5 days2.6 daysp =0470.47(SD 1.4)(SD 1.5)(SD 1.6)

Symptomatic and FunctionalRecovery Score (no statistical difference)2520Group x Time P=0.24Group P=0.47OMT (n=99)LT (n=102)15 CCO (n=99)105Mean SFRS (SD)0Admission 14 -day 30 -day 60 -dayMeasurement Point

Treatment End Point Data:Intent to treat analysisOMT LT CCOn = 124 n = 124 n = 132Death2% 3% 6%RespiratoryFailureDischargedAlive3% 3% 8%95% 94% 86% p = 0.08

Treatment End Point Data:By per protocol analysisOMT LT CCOn = 96 n = 95 n = 132Death 0% 3% 6%RespiratoryFailureDischargedAlive1% 2% 7%99% 95% 87% p = 0.006

Treatment EndpointIntention-to-TreatAnalysisPer-ProtocolAnalysis100%95% 94%86%100%99% 95%87%80%P=0.0880%P=0.00660%60%40%40%20%0%6% 8%2% 3% 3% 3%20%0%6% 7%3%0% 1% 2%DeathRespiratoryFailureDischargedAliveDeathRespiratoryFailureDischargedAliveOMT (n=124) LT (n=124) CCO (n=132)OMT (n=96) LT (n=95) CCO (n=127)

60-Day Readmission RateOMT LT CCOBy intention to treat analysisn =93 n=96 n=9617 % 20 % 21 % p = 0.64OMT LT CCOBy per protocol analysisN = 80 N = 79 N = 9211 % 20 % 21 % p = 0.16

Blinding: Percent CorrectlyIdentifying their GroupIntention to treat analysisOMT LT CCO53 % 44 % 49 %Per protocol analysisproduced similar numbers

Conclusions andDiscussion

Conclusions•By ITT analysis– outcomes not improved• By PP analysis– OMT decreased LOS, duration IV antibiotics,and Mortality• Relative to the CCO group• LT groups– outcomes tended to fall between the OMT andCCO outcomes

Changing Mean Length of Stay forPneumonia in the Elderlyl

Points for Discussion• Does the shortened hospital LOS make OMTobsolete?– Where might OMT find a therapeutic role?• How significant are the positive outcomes?– ITT analysis verses PP analysis• Is LT more like OMT or CCO?– How should the three group outcomes beinterpreted?

Stay tuned for the panel discussionMOPSE Research Team