Drug Therapy Management Clinical Trial
Official title:
Durchführung Einer Beobachtungsstudie im Rahmen Einer Masterarbeit Zur Identifikation Von Pharmaceutical Care Issues Bei Patienten, Welche Mit Oralen Antikoagulantien Behandelt Werden
| Verified date | December 2016 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Observational |
Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict adherence is needed.Thus, medication review and identification of safety issues and knowledge gaps about OAC is critically important. The polymedication check (PMC) is a reimbursed intermediate medication review focusing on adherence and medication management for Swiss primary care. Investigators aime to assess the impact of the PMC extended with a semi-structured interview focusing on OAC.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | December 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - intake of an oral anticoagulant - more than 3 drugs over at least 3 months prior to recruitment - german language (written and spoken) - medicines use in self management Exclusion Criteria: - living in a nursing home - provision of polymedication check in the past |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Pharmaceutical Care Research Group University of Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | University of Basel |
Switzerland,
Bryant LJ, Coster G, Gamble GD, McCormick RN. The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy. Int J Pharm Pract. 2011 Apr;19(2):94-105. doi: 10.1111/j.2042-7174.2010.00079.x. — View Citation
Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. — View Citation
Krska J, Avery AJ; Community Pharmacy Medicines Management Project Evaluation Team.. Evaluation of medication reviews conducted by community pharmacists: a quantitative analysis of documented issues and recommendations. Br J Clin Pharmacol. 2008 Mar;65(3):386-96. — View Citation
Kwint HF, Faber A, Gussekloo J, Bouvy ML. Effects of medication review on drug-related problems in patients using automated drug-dispensing systems: a pragmatic randomized controlled study. Drugs Aging. 2011 Apr 1;28(4):305-14. doi: 10.2165/11586850-000000000-00000. — View Citation
Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team.. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Knowledge gaps about oral anticoagulation therapy | Knowledge about oral anticoagulation therapy will be assessed during the extended Polymedication check which includes 8 specific questions on oral anticoagulation knowledge. After 2 Weeks a follow-up telephone interview will be performed and the same 8 questions will be assessed. | 2 Weeks | No |
| Secondary | Medication possessio ratio (MPR) | Medication history from pharmacy software will be used to calculate the MPR of all drugs, retrospectively starting 12 months before the extended PMC takes place. | 12 Months | No |