The Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) as an eHealth Approach to Presurgical Hip Replacement Education: Protocol for a Randomized Controlled Trial

William C Miller, Somayyeh Mohammadi, Wendy Watson, Morag Crocker, Marie Westby, William C Miller, Somayyeh Mohammadi, Wendy Watson, Morag Crocker, Marie Westby

Abstract

Background: Osteoarthritis (OA), leading to hip replacement (THR), is a primary contributor to global mobility impairment. In 2018, more than 59,000 THR surgeries were performed in Canada. Health promotion education, such as prehabilitation, is vital to optimizing surgical outcomes.

Objective: This study aims to evaluate the feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER), an eHealth approach to prehabilitation education.

Methods: A single-blind (assessor-blind), 2-arm, feasibility randomized controlled trial will be conducted. We will recruit 40 (HIPPER group, n=20; control group, n=20) older adults with hip OA and on a waitlist for a THR. The HIPPER intervention consists of 12 online, interactive modules. The control group will receive the current standard practice consisting of 2 online educational sessions lasting 2 hours each (webinars). Feasibility outcomes (eg, recruitment and retention rates) will be evaluated.

Results: Recruitment started in March 2021. As of April 20, 2021, 18 participants were recruited. All 18 completed T1 measures. Only 1 participant has been scheduled to have a surgery and therefore has been scheduled to complete T2 measures. The remainder of the participants are waiting to be notified of their surgery date. This project was funded by a Canadian Institutes of Health Research Project Grant. Our institute's research ethics board approved this study in November 2016.

Conclusions: Results will lead to refinement of the HIPPER protocol in order to evaluate a standardized and geographically accessible prehabilitation program.

Trial registration: ClinicalTrials.gov NCT02969512; https://ichgcp.net/clinical-trials-registry/NCT02969512.

International registered report identifier (irrid): DERR1-10.2196/29322.

Keywords: bone; eHealth; education; evaluation; feasibility; hip; osteoarthritis; prehabiliatation; preoperative education; randomized controlled trial; recovery; rehabilitation; surgery; total hip replacement.

Conflict of interest statement

Conflicts of Interest: None declared.

©William C Miller, Somayyeh Mohammadi, Wendy Watson, Morag Crocker, Marie Westby. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.07.2021.

Figures

Figure 1
Figure 1
Data collection procedure for the randomized controlled trial. HIPPER: Hip Instructional Prehabilitation Program for Enhanced Recovery.

References

    1. Metcalfe S, Ju H, Molodianovitsh K, Sidhom P, Faye L, Webste G. Knee Replacement in Canada: Canadian Joint Replacement Registry 2015 Annual Report. Canadian Institute for Health Information. 2015. Sep, [2021-06-27]. .
    1. Ruchlin H, Elkin E, Allegrante J. The economic impact of a multifactorial intervention to improve postoperative rehabilitation of hip fracture patients. Arthritis & Rheumatism. 2001;45(5):446–452. doi: 10.1002/1529-0131(200110)45:5<446::AID-ART364>. doi: 10.1002/1529-0131(200110)45:5<446::aid-art364>;2-r.
    1. Santavirta N, Lillqvist G, Sarvimäki A, Honkanen V, Konttinen Y, Santavirta S. Teaching of patients undergoing total hip replacement surgery. Int J Nurs Stud. 1994 Apr;31(2):135–42. doi: 10.1016/0020-7489(94)90040-x.
    1. Butler G, Hurley C, Buchanan K, Smith-VanHorne J. Prehospital education: effectiveness with total hip replacement surgery patients. Patient Education and Counseling. 1996 Nov;29(2):189–197. doi: 10.1016/0738-3991(96)00883-x.
    1. Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966–9. doi: 10.1139/apnm-2015-0084. doi: 10.1139/apnm-2015-0084.
    1. Moulton LS, Evans PA, Starks I, Smith T. Pre-operative education prior to elective hip arthroplasty surgery improves postoperative outcome. Int Orthop. 2015 Aug 11;39(8):1483–6. doi: 10.1007/s00264-015-2754-2.
    1. Ibrahim M, Twaij H, Giebaly D, Nizam I, Haddad F. Enhanced recovery in total hip replacement. The Bone & Joint Journal. 2013 Dec;95-B(12):1587–1594. doi: 10.1302/0301-620X.95B12.31303. doi: 10.1302/0301-620x.95b12.31303.
    1. Aydin D, Klit J, Jacobsen S, Troelsen A, Husted H. No major effects of preoperative education in patients undergoing hip or knee replacement--a systematic review. Dan Med J. 2015 Jul;62(7):1.
    1. Westby M, Marshall D, Jones C. Development of quality indicators for hip and knee arthroplasty rehabilitation. Osteoarthritis Cartilage. 2018 Mar;26(3):370–382. doi: 10.1016/j.joca.2017.10.020.
    1. McDonald S, Page MJ, Beringer K, Wasiak J, Sprowson A. Preoperative education for hip or knee replacement. Cochrane Database Syst Rev. 2014 May 13;(5):CD003526. doi: 10.1002/14651858.CD003526.pub3.
    1. Jayakumar N, Brunckhorst O, Dasgupta P, Khan MS, Ahmed K. e-Learning in Surgical Education: A Systematic Review. J Surg Educ. 2015 Nov;72(6):1145–57. doi: 10.1016/j.jsurg.2015.05.008.
    1. Gruner D, Pottie K, Archibald D, Allison J, Sabourin V, Belcaid I, McCarthy A, Brindamour M, Augustincic Polec L, Duke P. Introducing global health into the undergraduate medical school curriculum using an e-learning program: a mixed method pilot study. BMC Med Educ. 2015 Sep 02;15:142. doi: 10.1186/s12909-015-0421-3.
    1. van de Steeg L, IJkema R, Wagner C, Langelaan M. The effect of an e-learning course on nursing staff's knowledge of delirium: a before-and-after study. BMC Med Educ. 2015 Feb 05;15(1):12. doi: 10.1186/s12909-015-0289-2.
    1. Parker SJ, Jessel S, Richardson JE, Reid MC. Older adults are mobile too!Identifying the barriers and facilitators to older adults' use of mHealth for pain management. BMC Geriatr. 2013 May 06;13(1):43. doi: 10.1186/1471-2318-13-43.
    1. Martin T. Assessing mHealth: opportunities and barriers to patient engagement. J Health Care Poor Underserved. 2012 Aug;23(3):935–41. doi: 10.1353/hpu.2012.0087.
    1. Internet use by location of use, age group, household income and geography. Statistics Canada. 2019. [2019-11-21]. .
    1. Knowles M. The Adult Learner: A Neglected Species. Madison, WI: American Society for Training and Development; 1978. p. 20.
    1. Kujala S. User involvement: A review of the benefits and challenges. Behaviour & Information Technology. 2003 Jan;22(1):1–16. doi: 10.1080/01449290301782.
    1. Chan A, Tetzlaff J, Altman D, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré CJ, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold F, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 05;158(3):200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Duivenvoorden T, Vissers M, Verhaar J, Busschbach J, Gosens T, Bloem R, Bierma-Zeinstra S, Reijman M. Anxiety and depressive symptoms before and after total hip and knee arthroplasty: a prospective multicentre study. Osteoarthritis Cartilage. 2013 Dec;21(12):1834–40. doi: 10.1016/j.joca.2013.08.022.
    1. Rolfson O, Wissig S, van Maasakkers L, Stowell C, Ackerman I, Ayers D, Barber T, Benzakour T, Bozic K, Budhiparama N, Caillouette J, Conaghan PG, Dahlberg L, Dunn J, Grady-Benson J, Ibrahim SA, Lewis S, Malchau H, Manzary M, March L, Nassif N, Nelissen R, Smith N, Franklin PD. Defining an International Standard Set of Outcome Measures for Patients With Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res (Hoboken) 2016 Nov 26;68(11):1631–1639. doi: 10.1002/acr.22868. doi: 10.1002/acr.22868.
    1. Dobson F, Hinman R, Roos E, Abbott J, Stratford P, Davis A, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell K. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042–52. doi: 10.1016/j.joca.2013.05.002.
    1. Nilsdotter A, Bremander A. Measures of hip function and symptoms: Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), Lequesne Index of Severity for Osteoarthritis of the Hip (LISOH), and American Academy of Orthopedic Surgeons (AAOS) Hip and Knee Questionnaire. Arthritis Care Res (Hoboken) 2011 Nov 07;63 Suppl 11(S11):S200–7. doi: 10.1002/acr.20549. doi: 10.1002/acr.20549.
    1. Naal FD, Sieverding M, Impellizzeri FM, von Knoch F, Mannion AF, Leunig M. Reliability and validity of the cross-culturally adapted German Oxford hip score. Clin Orthop Relat Res. 2009 Apr;467(4):952–7. doi: 10.1007/s11999-008-0457-3.
    1. Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141–52. doi: 10.1002/pri.411.
    1. Gill SD, de Morton NA, Mc Burney H. An investigation of the validity of six measures of physical function in people awaiting joint replacement surgery of the hip or knee. Clin Rehabil. 2012 Oct 09;26(10):945–51. doi: 10.1177/0269215511434993.
    1. Washburn RA, McAuley E, Katula J, Mihalko SL, Boileau RA. The physical activity scale for the elderly (PASE): evidence for validity. J Clin Epidemiol. 1999 Jul;52(7):643–51. doi: 10.1016/s0895-4356(99)00049-9.
    1. Svege I, Kolle E, Risberg MA. Reliability and validity of the Physical Activity Scale for the Elderly (PASE) in patients with hip osteoarthritis. BMC Musculoskelet Disord. 2012 Feb 21;13(1):26. doi: 10.1186/1471-2474-13-26.
    1. Waldrop D, Lightsey ORJ, Ethington CA, Woemmel CA, Coke AL. Self-efficacy, optimism, health competence, and recovery from orthopedic surgery. Journal of Counseling Psychology. 2001;48(2):233–238. doi: 10.1037/0022-0167.48.2.233.
    1. Stevens M, van den Akker-Scheek I, van Horn JR. A Dutch translation of the Self-Efficacy for Rehabilitation Outcome Scale (SER): a first impression on reliability and validity. Patient Educ Couns. 2005 Aug;58(2):121–6. doi: 10.1016/j.pec.2004.07.005.
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Brooke J. SUS: A quickdirty usability scale. In: Jordan PW, Thomas B, McClelland BA, Weerdmeester LI, editors. Usability Evaluation in Industry. London: Taylor & Francis; 1996.
    1. Billingham S, Whitehead A, Julious S. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
    1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist. 2005 Oct;4(4):287–291. doi: 10.1002/pst.185.
    1. Vranceanu A, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5(1):30. doi: 10.1186/s40814-019-0416-7.
    1. Singal A, Higgins P, Waljee A. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol. 2014 Jan 02;5:e45. doi: 10.1038/ctg.2013.13.
    1. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10(1):67. doi: 10.1186/1471-2288-10-67.
    1. Randomisation and Online Databases for Clinical Trials. Sealed Envelope. [2021-06-08]. .
    1. Brosseau L, Wells G, Brooks-Lineker S, Bennell K, Sherrington C, Briggs A, Sturnieks D, King J, Thomas R, Egan M, Loew L, De Angelis G, Casimiro L, Toupin April K, Cavallo S, Bell M, Ahmed R, Coyle D, Poitras S, Smith C, Pugh A, Rahman P. Internet-based implementation of non-pharmacological interventions of the "people getting a grip on arthritis" educational program: an international online knowledge translation randomized controlled trial design protocol. JMIR Res Protoc. 2015 Feb 03;4(1):e19. doi: 10.2196/resprot.3572.
    1. Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234–8. doi: 10.1016/j.jclinepi.2007.02.006.
    1. Dimitrov D, Rumrill P. Pretest-posttest designs and measurement of change. Work. 2003;20(2):159–65.
    1. Overall JE, Spiegel DK. Concerning least squares analysis of experimental data. Psychological Bulletin. 1969;72(5):311–322. doi: 10.1037/h0028109.
    1. Moncur RA, Larmer JC. Clinical applicability of intention-to-treat analyses. Evidence Based Medicine. 2009;6(1):39–41. doi: 10.2307/j.ctt20p57sd.24.
    1. DeMets D. Datasafety monitoring boards. Armitage P, Colton T. editors. Chichester: John Wiley & Sons; 1998.
    1. OsteoArthritis Service Integration System (OASIS) Vancouver Coastal Health. [2021-06-08].
    1. Jayakumar N, Brunckhorst O, Dasgupta P, Khan MS, Ahmed K. e-Learning in Surgical Education: A Systematic Review. J Surg Educ. 2015 Nov;72(6):1145–57. doi: 10.1016/j.jsurg.2015.05.008.
    1. Dear BF, Zou JB, Ali S, Lorian CN, Johnston L, Terides MD, Staples LG, Gandy M, Fogliati VJ, Klein B, Titov N. Examining self-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety and depression: Two feasibility open trials. Internet Interventions. 2015 Mar;2(1):17–23. doi: 10.1016/j.invent.2014.11.002.
    1. Alley SJ, Kolt GS, Duncan MJ, Caperchione CM, Savage TN, Maeder AJ, Rosenkranz RR, Tague R, Van Itallie AK, Kerry Mummery W, Vandelanotte C. The effectiveness of a web 2.0 physical activity intervention in older adults - a randomised controlled trial. Int J Behav Nutr Phys Act. 2018 Jan 12;15(1):4. doi: 10.1186/s12966-017-0641-5.
    1. Hip and Knee Replacements in Canada, 2017-2018: Canadian Joint Replacement Registry Annual Report Internet. Canadian Institute for Health Research. 2019. [2019-11-21]. .
    1. Canada IFHI. Hip and Knee Replacements in Canada: Canadian Joint Replacement Registry 2015 Annual Report Internet. Canada Institute for Health Information. [2018-03-02]. .
    1. Visual Census – Language, Vancouver. Statistics Canada. 2012. [2018-03-02]. .
    1. Tiedeman DV, Knowles M. The Adult Learner: A Neglected Species. Educational Researcher. 1979 Mar;8(3):20. doi: 10.2307/1174362.
    1. Hróbjartsson A, Emanuelsson F, Skou Thomsen AS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol. 2014 Aug;43(4):1272–83. doi: 10.1093/ije/dyu115.
    1. Day S, Altman D. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000;321(7259):504. doi: 10.1136/bmj.321.7259.504.
    1. Deyo RA, Walsh NE, Schoenfeld LS, Ramamurthy S. Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain. Am J Phys Med Rehabil. 1990 Feb;69(1):6–10. doi: 10.1097/00002060-199002000-00003.

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