Optimizing PharmacoTherapy In the Multimorbid Elderly in Primary CAre: the OPTICA Trial

NCT03724539 | Completed DMC

• 1 other identifier: U1111-1181-9400
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistant (STRIPA) and implemented by general practitioners (GPs), will lead to an improvement in clinical and economic outcomes in patients aged 65 or older with multimorbidity and polypharmacy.

Conditions

Multimorbidity; Polypharmacy

Keywords

Drug utilization review; Old age

Outcome Measures

Primary Outcomes (2)

• Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI)

  Medication Appropriateness Index (MAI), assessed at baseline as well as at the 6 and 12 months follow-ups for each chronic medication of the patient. The 10 item version of the MAI will be used, but the cost-effectiveness item will be excluded. The MAI score for each medication will range from 0 to 17.

  12 months

• Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU)

  Assessment of Underutilization (AOU), assessed for each of the patients' chronic conditions at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.

  12 months

Secondary Outcomes (14)

• Patients' degree of polypharmacy

  12 months

• Patients' degree of overprescribing, as measured by the Medication Appropriateness Index (MAI)

  12 months

• Patients' degree of underprescribing, as measured by the Assessment of Underutilization

  12 months

• Patients' falls and fractures

  12 months

• Patients' quality of life measured by 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D), including pain/discomfort.

  12 months

Study Arms (2)

STRIPA intervention

EXPERIMENTAL

GPs in the intervention group will perform a STRIPA analysis for each of their 8-10 patients after the recruitment of the patient into the OPTICA trial, so that the results can be discussed in the next consultation and a shared decision-making can be performed. STRIPA is a structured method to perform pharmacotherapy optimization. The STRIPA intervention in the OPTICA trial consists of 4 steps: 1. recording medication and diagnoses in STRIPA (upload from data from the 'Family medicine ICPC Research using Electronic medical records' (FIRE) database) 2. structured drug review through the GP based on the STRIPA with the integrated STOPP/START criteria 3. shared decision-making between GP and patient with possible adaptation of the recommendation 4. follow-up through study team

Device: STRIPA intervention

Sham intervention

SHAM COMPARATOR

Patients in the control group will receive a sham intervention, which consists of a usual medication review by their GP as well as a shared decision making of the latter.

Other: Sham intervention

Interventions

STRIPA intervention DEVICE

STRIPA is a Dutch software-based tool for the support of the pharmaceutical analysis by 1) taking into account the predictable adverse medication effects, 2) advising safe and appropriate therapy using established STOPP/START criteria, 3) interaction monitoring, and 4) appropriate dosing in accordance with renal function. It represents a highly efficient and user-friendly software engine, which is capable of individually screening the clinical status and pharmacological therapy of older patients with multimorbidity, which can define optimal drug therapy, and which can highlight the adverse drug reaction risk. A summary of these outputs will be used as STRIPA recommendations, which will, if applicable, be implemented by GPs and patients. Prior to the STRIPA medication review, the necessary patient information will be loaded from the FIRE database that contains data from more than 300 Swiss GP practices.

STRIPA intervention

Sham intervention OTHER

Patients being assigned to the control arm will be treated in accordance with standard care. They will receive a sham intervention, which consists of a usual medication review by their GP and a shared decision making between patient and GP.

Sham intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Being a regular patient of participating GP
• Age: 65 years of age or older
• Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification in Primary Care -2 (ICPC-2) codes defined as chronic (O'Halloran et al., 2004) with an estimated duration of 6 months or more, or based on a clinical decision supported by Pharmacost Groups (PCG) for chronic conditions in an algorithm from FIRE
• Polypharmacy: Use of five or more different regular drugs (defined as authorized medications with registration numbers) for more than 30 days before signing the informed consent form

You may not qualify if:

• Inability to provide informed consent from a patient or to obtain informed consent from a proxy for patients with cognitive impairment
• If the patient is already participating in the a different interventional study

Sponsors & Collaborators

• University of Bern: lead
• Utrecht University: collaborator
• University of Basel: collaborator
• University of Zurich: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (1)

Berner Institut für Hausarztmedizin, BIHAM

Bern, 3012, Switzerland

Location

Related Publications (16)

• Barry PJ, Gallagher P, Ryan C, O'mahony D. START (screening tool to alert doctors to the right treatment)--an evidence-based screening tool to detect prescribing omissions in elderly patients. Age Ageing. 2007 Nov;36(6):632-8. doi: 10.1093/ageing/afm118. Epub 2007 Sep 19.

  PMID: 17881418 BACKGROUND

• Chmiel C, Bhend H, Senn O, Zoller M, Rosemann T; FIRE study-group. The FIRE project: a milestone for research in primary care in Switzerland. Swiss Med Wkly. 2011 Jan 28;140:w13142. doi: 10.4414/smw.2011.13142. eCollection 2011.

  PMID: 21279858 BACKGROUND

• Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008 Nov;37(6):673-9. doi: 10.1093/ageing/afn197. Epub 2008 Oct 1.

  PMID: 18829684 BACKGROUND

• Gallagher PF, O'Connor MN, O'Mahony D. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria. Clin Pharmacol Ther. 2011 Jun;89(6):845-54. doi: 10.1038/clpt.2011.44. Epub 2011 Apr 20.

  PMID: 21508941 BACKGROUND

• Jadad AR, To MJ, Emara M, Jones J. Consideration of multiple chronic diseases in randomized controlled trials. JAMA. 2011 Dec 28;306(24):2670-2. doi: 10.1001/jama.2011.1886. No abstract available.

  PMID: 22203536 BACKGROUND

• Meulendijk M, Spruit M, Drenth-van Maanen C, Numans M, Brinkkemper S, Jansen P. General practitioners' attitudes towards decision-supported prescribing: an analysis of the Dutch primary care sector. Health Informatics J. 2013 Dec;19(4):247-63. doi: 10.1177/1460458212472333.

  PMID: 24255051 BACKGROUND

• Meulendijk MC, Spruit MR, Willeboordse F, Numans ME, Brinkkemper S, Knol W, Jansen PA, Askari M. Efficiency of Clinical Decision Support Systems Improves with Experience. J Med Syst. 2016 Apr;40(4):76. doi: 10.1007/s10916-015-0423-z. Epub 2016 Jan 20.

  PMID: 26791992 BACKGROUND

• Samsa GP, Hanlon JT, Schmader KE, Weinberger M, Clipp EC, Uttech KM, Lewis IK, Landsman PB, Cohen HJ. A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994 Aug;47(8):891-6. doi: 10.1016/0895-4356(94)90192-9.

  PMID: 7730892 BACKGROUND

• Somers A, Mallet L, van der Cammen T, Robays H, Petrovic M. Applicability of an adapted medication appropriateness index for detection of drug-related problems in geriatric inpatients. Am J Geriatr Pharmacother. 2012 Apr;10(2):101-9. doi: 10.1016/j.amjopharm.2012.01.003. Epub 2012 Feb 1.

  PMID: 22304791 BACKGROUND

• O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.

  PMID: 25324330 BACKGROUND

• Jeffry S, Ruby C, Twersky J, Hanlon JT. Effect of an interdisciplinary team on suboptimal prescribing in a long-term care facility. The Consultant Pharmacist 14(12):1386-91, 1994.

  BACKGROUND

• Jungo KT, Deml MJ, Schalbetter F, Moor J, Feller M, Luthold RV, Huibers CJA, Sallevelt BTGM, Meulendijk MC, Spruit M, Schwenkglenks M, Rodondi N, Streit S. A mixed methods analysis of the medication review intervention centered around the use of the 'Systematic Tool to Reduce Inappropriate Prescribing' Assistant (STRIPA) in Swiss primary care practices. BMC Health Serv Res. 2024 Mar 18;24(1):350. doi: 10.1186/s12913-024-10773-y.

  PMID: 38500163 DERIVED

• Jungo KT, Weir KR, Cateau D, Streit S. Older adults' attitudes towards deprescribing and medication changes: a longitudinal sub-study of a cluster randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e075325. doi: 10.1136/bmjopen-2023-075325.

  PMID: 38199626 DERIVED

• Jungo KT, Ansorg AK, Floriani C, Rozsnyai Z, Schwab N, Meier R, Valeri F, Stalder O, Limacher A, Schneider C, Bagattini M, Trelle S, Spruit M, Schwenkglenks M, Rodondi N, Streit S. Optimising prescribing in older adults with multimorbidity and polypharmacy in primary care (OPTICA): cluster randomised clinical trial. BMJ. 2023 May 24;381:e074054. doi: 10.1136/bmj-2022-074054.

  PMID: 37225248 DERIVED

• Jungo KT, Meier R, Valeri F, Schwab N, Schneider C, Reeve E, Spruit M, Schwenkglenks M, Rodondi N, Streit S. Baseline characteristics and comparability of older multimorbid patients with polypharmacy and general practitioners participating in a randomized controlled primary care trial. BMC Fam Pract. 2021 Jun 22;22(1):123. doi: 10.1186/s12875-021-01488-8.

  PMID: 34157981 DERIVED

• Jungo KT, Rozsnyai Z, Mantelli S, Floriani C, Lowe AL, Lindemann F, Schwab N, Meier R, Elloumi L, Huibers CJA, Sallevelt BTGM, Meulendijk MC, Reeve E, Feller M, Schneider C, Bhend H, Burki PM, Trelle S, Spruit M, Schwenkglenks M, Rodondi N, Streit S. 'Optimising PharmacoTherapy In the multimorbid elderly in primary CAre' (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial. BMJ Open. 2019 Sep 3;9(9):e031080. doi: 10.1136/bmjopen-2019-031080.

  PMID: 31481568 DERIVED

Related Links

• Project description by National Research Programme 74 "Smarter Healthcare" (NRP74) / Swiss National Science Foundation (SNSF)

Study Officials

• Sven Streit, Prof., MD, PhD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The OPTICA study is partially blinded, with blinding being implemented as follows: * Due to the nature of the study intervention participating GPs (care providers) cannot be blinded. * Patients remain blinded. They will not be informed to which treatment arm their GP is allocated to, in order to minimize performance and other reporting biases. Despite this, they receive a "high-level description" of the study question and the study procedures. * Data collection for primary and secondary outcome analyses will be conducted by blinded study team members. * Outcome adjudication (MAI and AOU assessment) will be performed by blinded study team members.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clusters will be randomized 1:1, to either the intervention arm receiving STRIPA or to the control arm undergoing a sham intervention. Each cluster is defined by one GP. The patients assigned to a cluster (i.e. GP) which was allocated to the intervention arm will undergo a systematic pharmacotherapy optimization by their GP using the STRIP assistant and shared decision making. Patients assigned to a cluster that was assigned to the control arm will receive a sham intervention, which consists of a usual medication review by the GP in accordance with usual care and shared decision making. This RCT randomizes GPs instead of patients to prevent contamination, which would occur if the same GPs treated patients in the intervention and the control arm simultaneously.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 30, 2018
• Study Start: January 7, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)