Coronary Heart DiseaseNCT01115608
Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients
A study testing Pharmacist follow-up in people with Coronary Heart Disease, run by Hospital Pharmacy of North Norway Trust at 1 site in Norway.
Trial summary
Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Pharmacist follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2009to 30 Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established coronary heart disease
- age 18 - 80 years
- patients living in the three nearby communities Tromsoe, Balsfjord and Karlsoey, this because they need to see the pharmacist personally.
Who cannot join
- patients living in nursing homes
- patients included in NORstent, another trial including patients at the same department
- patients already receiving pharmaceutical follow-up elsewhere
- cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Standardized Clinical Pharmacist Service for Patients Discharged From Hospital. Measurement of Drug Prescribing Quality in Secondary Prevention of Coronary Heart Disease Utilizing a Medication Assessment Tool (MAT-CHDsp)
Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls.
Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P < 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients.
No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.
Read the detailed description
Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf
- Conditions
- Coronary Heart Disease
- Being tested
- Pharmacist follow-up
- Keywords
- Preventive Health Services
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist follow-upOther
Drug review, drug conversation and written drug information. Follow-up concerning therapeutic goals and cooperation with the patient and the patient's GP to achieve these.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist follow-up | Experimental | The patients will receive pharmaceutical follow-up during one year after discharge from the hospital. Three meetings are arranged, one at discharge, one after three months and the last after one year. Patients will be called up for arrangement of "consultation". Written information concerning drugs used will be supplied. Receives: Other: Pharmacist follow-up |
| Control group | No intervention | The control group receives no follow-up from the pharmacist, but will after one year, when they are out of the study, receive one follow-up visit and drug review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.
Measured: At baseline (both arms)
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.
Measured: After one year (both arms)
Secondary outcomes (2)
Drug related problems
Medication reviews often reveals safety issues concerning the drug regime, except from the primary outcome measures. THese are noted and will be assessed and tried solved during follow-up in close cooperation with the GP.
Measured: At inclusion, after three months and after one year.
Hospitalisation
Data will be collected, both for the study group and for the control group, concerning hospitalisation during the year included in the study. The groups will be compared.
Measured: After one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study start1 Feb 2009
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pharmacy of North Norway Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Beate Hennie Garcia, PhD, Hospital Pharmacy of North Norway Trust
- Investigators
- Trude Giverhaug, Dr.Scient., Study chair, Hospital Pharmacy of North Norway Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115608
- Sponsor's protocol ID
- SHAN-001
- Status last verified
- Jun 2020
- First submitted
- 29 Apr 2010
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Standardized Clinical Pharmacist Service for Patients Discharged From Hospital. Measurement of Drug Prescribing Quality in Secondary Prevention of Coronary Heart Disease Utilizing a Medication Assessment Tool (MAT-CHDsp)
- ClinicalTrials.gov ID
- NCT01115608
- Acronym / sponsor ID
- SHAN-001
- Conditions
- Coronary Heart Disease
- Keywords
- Preventive Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital Pharmacy of North Norway TrustUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls.
Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P < 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients.
No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.
Detailed description
Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist follow-up | Experimental | Other: Pharmacist follow-upThe patients will receive pharmaceutical follow-up during one year after discharge from the hospital. Three meetings are arranged, one at discharge, one after three months and the last after one year. Patients will be called up for arrangement of "consultation". Written information concerning drugs used will be supplied. |
| Control group | No intervention | –The control group receives no follow-up from the pharmacist, but will after one year, when they are out of the study, receive one follow-up visit and drug review. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- established coronary heart disease
- age 18 - 80 years
- patients living in the three nearby communities Tromsoe, Balsfjord and Karlsoey, this because they need to see the pharmacist personally.
Key exclusion criteria (4 listed)
- patients living in nursing homes
- patients included in NORstent, another trial including patients at the same department
- patients already receiving pharmaceutical follow-up elsewhere
- cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist follow-upDrug review, drug conversation and written drug information. Follow-up concerning therapeutic goals and cooperation with the patient and the patient's GP to achieve these. | Other | Pharmacist follow-up |
Primary outcome
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
Time frame: At baseline (both arms)
MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
Time frame: After one year (both arms)
MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.
2 secondary outcomes
Drug related problems
Time frame: At inclusion, after three months and after one year.
Hospitalisation
Time frame: After one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Published ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trude Giverhaug, Dr.Scient. study chair
Hospital Pharmacy of North Norway Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist follow-up in people with Coronary Heart Disease, run by Hospital Pharmacy of North Norway Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations) (time frame: At baseline (both arms)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.