7. PHASE 3

Objectives and method

The work of phases one and two of the project was repeated to re-audit the facilities, equipment, staffing, ECT procedures, training and supervision and clinical outcome. Either the project co-ordinator or project worker revisited each ECT suite. The visit was unannounced and involved viewing an actual treatment session in progress. This enabled closer scrutiny of procedure and protocol at ECT and an impression of inter disciplinary collaboration. Patient consent forms were viewed and a judgement made of their current validity.* The quality of nursing care was assessed and the anaesthetist asked for his/her views on equipment and staffing. The junior doctor giving the ECT was asked for his/her impression of training and supervision. Outcome based on a further nine months of data (collected between 01/08/98 and 30/04/99) was analysed and inter site variation examined to try and identify aspects of good practice to inform the production of guidelines on the optimum treatment package for ECT.

• The important question of assessing the validity of the patients informed consent is a methodologically and ethically complex issue (Cheshire and Freeman 1986). This has formed the basis of many debates between user group representatives and clinicians. The discussions are ongoing and it is likely that a separate research project will be required to provide the answer.

Results (July 1999)

i. Premises and equipment: The one site considered unacceptable during phase 1 had been closed and patients who required ECT were being transferred to a neighbouring hospital. All sites now had tilting beds or trolleys and a standard of anaesthetic equipment acceptable to the anaesthetists interviewed who gave a rating as in Annex D of good (57%) or adequate (34%).

ii. Staffing: Responsibility for each ECT service remained with a senior psychiatrist and 14% now had contracted sessional time for this commitment (cf. 6% in phase one). All anaesthetists were again of a senior grade and 13 clinics had an anaesthetic assistant. The standard of nursing remained high with 89% of nursing staff actively involved in the ECT treatment being defined as either designated or special interest. Against the standard set for nursing levels (see Annex E) staffing was rated as follows:

Adequate number of staff: In preparation - 32 (100%) During treatment - 32 (100%) In recovery - 30 (93.8%)

iii. ECT practice: The ECT treatment schedule was now the responsibility of 33 ECT consultants as opposed to 2 units where this was still decided by the consultant from the clinical team. 66% of clinics (cf. 52%) had now adapted their ECT form to include written prescription of treatments. There were an increased number of clinics (89% cf. 78%) either measuring or estimating the first ECT dose in line with College recommendations and 94%* employed a stimulus dosing protocol. A written policy for the termination of prolonged seizures was now easily available in 71% of treatment rooms and clinical information from case notes at 97% of sites. [* Since completion of the audit all centres now employ a stimulus dosing protocol.]

iv. Training and supervision: This time round the junior doctor delivering the treatment, in contrast to the consultant, was asked for his/her opinion of training and supervision. The main problem identified in phase one had been with good ongoing supervision. Although somewhat improved overall at 50% (cf. 45%) good ongoing supervision was still an area of concern.

Table 12: Phase 3 (1998) overall ratings (refer to Annex D)

* Changes of staff and illness were the reasons given for the very poor training and supervision at this site where ECT numbers were low. Since completion of the audit arrangements have been made to give ECT at a different site.

v. ECT usage

All sites returned some data. The reasons given for missing data were long term sickness or key personnel changes in units which depended on one person for data collection.

Table 13: ECT usage during Phase 3

(Ref: SMRO 1991, National Census and ISD)

Again prescription rates varied throughout the country but no significant trend could be seen to explain this.

vi. Demographic data

Table 14: Age and sex of patients receiving ECT during Phase 3 of the audit

• All but 6 patients (1%) were white, a figure which remains below the proportion of black and Asian people within the Scottish population as a whole (1.25%).
• Again the ratio of female to male patients (F:M = 1.9:1) reflected the higher number of female admissions for depressive illness. (F:M = 1.6:1; Scottish Health Statistics 1998)
• As in phase two 92% were in-patients and twice weekly treatments were the norm (96%).
• 10 patients were given only unilateral ECT and 4 others some unilateral in addition to (mainly) bilateral treatment, otherwise the bilateral electrode placement was used.

vii. Legal Status and consent at outset (refer to Annex F)

Table 15: Legal status and consent at outset during Phase 3 of the audit

* S102 is a record of urgent treatment rather than a consent document per se. A second opinion doctor, appointed by the Mental Welfare Commission, gave permission for further ECT for this patient.

The number of patients detained under the Mental Health Act again fell by 1% during the course of ECT.

During Phase 3 of the audit it was agreed by ECT co-ordinators that any relevant Mental Health Act documentation should be available for the ECT suite staff before treatment proceeds. This means that copies of any statutory form should be physically present and staff should refuse to administer ECT without it. This tightens up the procedure whereby it was assumed such forms were held in the records department, or, in the case of a second opinion, in the post. The Mental Welfare Commission has taken steps to ensure that Second Opinion doctors are aware of this requirement and has now issued Guidelines for Consent at ECT (Annex F).

viii. Diagnosis and indication for ECT

Again the majority of patients suffered from a depressive illness (87%). A further 6.3% were diagnosed as having a schizophrenic illness and 3% a manic illness. 1.5% suffered from a neurotic disorder and no diagnosis was recorded for 2.2% of patients.

Table 16: Indications for ECT during Phase 3 of the audit

Indications for ECT (as many as relevant)

ix. Efficiency of the ECT session

The un-announced visit to watch an ECT session in progress gave an opportunity to assess how well the treatment team followed the protocols in place. Ratings, according to the scale at Annex D, were made as follows:

Table 17: Efficiency rating of the ECT clinics during Phase 3 of the audit

All informal patients had signed a consent form and this consent still appeared valid. The statutory documentation was available for all those patients detained under the Mental Health Act.

The consultant was present at 56% of sessions and overall the ECT treatment was judged to be effective, as indicated by seizure length, on 97% of occasions (65/67).

At the time of the visit only two sites had failed to begin collection of audit data but were encouraged to collect as much information as possible retrospectively.

x. Outcome measures

Data was returned for 426 courses of ECT representing 74% of the audit forms returned (426/578) and 57% of the total number of courses given (426/752). Four sites failed to return at least 50% of data and this brought the otherwise high average return down. Three of these sites have now improved their collection systems and the other has ceased to function. Results were consistent with those of phase two.

For MADRS scores the standard set for good outcome remained at a 50% reduction in at least 70% of patients. Results are summarised in table 18.

Table 18: MADRS score (depressive illness) during Phase 3 of the audit

(n=349 patients)

For CGIC scores the standard set was a definite clinical improvement in the majority of patients and results are given in table 19.

Table 19: Clinical Global Impression of Change (CGIC) (all patients) during Phase 3 of the audit

Again it was shown that ECT given in a routine clinical setting was effective for the clear majority of patients suffering from a mood disorder. Factor analysis failed to show any strong correlation between outcome and indication for ECT, severity of MADRS score, type of ECT machine used or stimulus dosing schedule employed.

xi. Untoward events

58 (10%) out of the 579 courses of treatment were discontinued prior to completion as a result of some untoward event. Reasons given were:

Table 20: Reasons for discontinuation ECT during Phase 3 of the audit

(* see Table 21).

See section 9 for a discussion on adverse events temporally related to ECT.