Trial Outcomes & Findings for The Adverse Drug Reaction (ADRe) Profile for Polypharmacy (NCT NCT03955133)

Last Updated: 2021-08-17

Results Overview

Number of participant with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

3 months from start of intervention

Results posted on

2021-08-17

Participant Flow

There was no arm / group assignment. This was a single arm study.

Unit of analysis: care homes

Participant milestones

Participant milestones
Measure	Intervention This is a single arm before and after study with data collection at 4 time points. The full range of signs and symptoms possibly related to adverse effects of commonly prescribed medicines was collected. Only the first and last data sets were analysed. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Overall Study STARTED	19 3
Overall Study COMPLETED	19 3
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=19 Participants This is a single arm before and after study with data collection at 4 time points. Only the first and last results were analysed. The results comprise the full range of signs and symptoms associated with possible adverse effects of commonly prescribed medicines. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	17 Participants n=93 Participants
Age, Continuous	74.8 years STANDARD_DEVIATION 15.2 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=93 Participants
Region of Enrollment United Kingdom	19 participants n=93 Participants
problems identified per resident	16 problems n=93 Participants

PRIMARY outcome

Timeframe: 3 months from start of intervention

Population: care home residents

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants This is a single arm before and after study with data collection at 4 time points. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents	17 Participants

SECONDARY outcome

Timeframe: Baseline, then 3 months from start of intervention

Population: problems recorded for each resident. Change between start and end of study.

Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months.

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants This is a single arm before and after study with data collection at 4 time points. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Number of Clinical Gains Per Resident Between Baseline and 3 Months	3 number of problems addressed per residen Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Baseline, then 3 months from start of intervention

Population: care home residents

number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months)

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants This is a single arm before and after study with data collection at 4 time points. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Number of Medicines Prescribed: Change Between Baseline and 3 Months	0 number of medicines per resident Interval -1.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, then 3 months from start of intervention

Population: care home residents

Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number.

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants This is a single arm before and after study with data collection at 4 time points. Adverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
Number of Problems Listed on Profile	3 number of problems per resident Interval 0.0 to 5.0

Adverse Events

Intervention. This is a Single Arm Before and After Study.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Sue Jordan

Swansea University

Phone: +44 (0) 1792518541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place